10:30 AM
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Evaluation of Data Requirements for Animal Derived Wound Care Devices: Limitations of the 510k Pathway
Introduction: Chronic wounds are an increasingly relevant public health concern and are typically managed with local wound care. Selecting an appropriate wound care product for patients can be challenging due to the numerous options available on the market and paucity of comparative data. Because these products are traditionally cleared through the 510K pathway, it is unclear whether the premarket data required by the Food and Drug Administration (FDA) provide sufficient information for providers to make informed patient-specific decisions.
Methods: The publicly available online 510K database was queried for all animal derived wound care products (KGN) and summary statements were reviewed. Data requirements for each product were recorded and reported as descriptive statistics.
Results: A total of 133 KGN products have been cleared through the 510K pathway since the FDA Center for Devices and Radiologic Health was established in 1976. Of these, only 114 had a publicly available clearance statement online. The most common animal component was porcine (48, 42%). Preclinical biocompatibility was performed in 85 (74.6%) and leveraged in 10 (8.8%) while preclinical wound healing testing in animals was only performed in 17 (14.9%) products. Clinical safety testing was performed for only 9 products (7.9%), and no products provided clinical effectiveness data from patients.
Conclusion: While the 510K pathway provides an appropriate avenue for clearing new wound care products, clinical effectiveness was never evaluated in regulatory review. Wound care products are primarily evaluated by FDA for safety and biocompatibility, and any claims of effectiveness for wound healing require independent validation.
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10:35 AM
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Effect of a Perioperative Educational Video about Mohs Reconstruction: A Randomized Clinical Trial
Purpose: The characteristics of defects created by Mohs micrographic surgery (MMS) is difficult to predict and may require complex reconstruction. This uncertainty about reconstructive options and cosmetic appearance may be difficult emotionally and cognitively for patients. While educational interventions have been evaluated for improving patient knowledge about MMS, few studies discuss the reconstructive and recovery journey that often involve plastic surgeons. We investigated the utility of an educational video to improve understanding among patient undergoing MMS about reconstruction with plastic surgeons.
Methods: A randomized clinical trial was conducted at an academic hospital in the US. The study was approved by the Vanderbilt University institutional review board. Inclusion criteria for study participation were: (1) adult patients (18 years or older) and (2) undergoing MMS with plastic surgery reconstruction. Patients were excluded if they were not undergoing reconstruction with a plastic surgeon or did not undergo MMS. Patients in the intervention arm watched an educational video about reconstruction after MMS which included content about reconstructive options and potential complications. All patients completed a 33-item survey about their understanding of reconstruction following MMS, satisfaction with their care, and the video if they received the intervention. A four-point Likert scale with responses "no understanding", "a little", "quite a bit", and "very much" was used to measure patient understanding. Demographics were described and Pearson χ2 tests with Rao-Scott correction were used to compare outcomes.
Results: A total of 18 patients were recruited for the study and completed the survey. Of these, 9 were randomized to the intervention group and viewed the educational video before completing the survey. There were no statistically significant differences in gender, marital status, race, and payer status among intervention and control groups. Although there were no statistically significant differences in educational attainment, 5 (55.6%) of patients in the control group had a master's degree or higher level of education compared to none in the intervention group.
Only one patient reported that cosmetic appearance was not important to them. All patients in the intervention group would recommend the video to family members with similar diagnoses and rated the video as useful and easy to understand. All patients also reported that they were "comfortable" or "very comfortable" having a plastic surgeon perform their reconstruction compared to a dermatologist (72.2%), otolaryngologist (44.4%), or general surgeon (61.1%). Compared to the control group, patients who watched the video were more likely to report "quite a bit" or "very much" understanding in regard to complications of reconstruction (100% vs 33.3%, P<.05), the difference between delayed and immediate reconstruction (100% vs 22.2%, P<.05), and the role of plastic surgery in reconstruction after MMS (100% vs 33.3%, P<.05). There were no differences in patient satisfaction between the groups.
Conclusions: This randomized clinical trial found that the use of a multimedia educational intervention improved patient understanding of reconstruction following MMS. Patients who watched the video were more likely to report understanding complications, surgical planning, and the role of plastic surgery.
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10:40 AM
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Chest Wall Reconstruction of Oncologic Defects: An Analysis of Post-Operative Outcomes
Chest wall reconstruction poses an engaging challenge, requiring protection of underlying thoracic structures while preserving respiratory function. The present study examines post-operative outcomes following chest wall reconstruction due to oncologic defects and the sequela of oncologic treatment.
Retrospective review of cases involving reconstruction of oncologic defects of the chest wall from October 2012- October 2022 was conducted. Cases involving primary resection, metastasectomy, infectious complications of oncologic procedures, or reconstructions needed due to adverse effects of prior treatments such as osteoradionecrosis were included for analysis. Patient demographics, cancer type, neoadjuvant and adjuvant therapy, type of reconstruction, and post-operative complications were compared.
36 patients (mean age of 59.5 years) were included. Male patients (52.8%, n=19) and white patients (72%, n=26) outnumbered female patients (47.2%, n=17) and black patients (27.7%, n=10), respectively. 62.9% of patients had a history of tobacco use, with 22.2% being current smokers. The mean BMI was 28.69 (SD±7.7). The prevalence of obesity and morbid obesity (BMI>40) was 19.4% and 11.1%, respectively. Neo-adjuvant (47.2% chemo-, 47.2% radio-) or adjuvant (41.7% chemo-, 16.7% radio-) therapy were common. Reconstruction consisted primarily of pedicled flap procedures (86.1%); including latissimus dorsi flaps (44.4%), followed by omental flaps (19.4%) and pectoralis muscle flaps (13.9%). Acellular dermal matrix or synthetic mesh was used in 27.8% of reconstructions. The mean length of stay was 10.77 days (SD ± 12.28), and the mean follow-up was 10.17 months (SD ±20.15).
The presence of any major complication occurred in 61.1% of patients; these primarily involved wound breakdown or dehiscence (25%), disease recurrence (22.2%), and cardiopulmonary complication or unplanned intubation (16.7%). Minor complications occurred in 27.8% of patients; primarily minor wound breakdown or dehiscence (19.4%), followed by seroma or hematoma managed conservatively (8.3%). There was a significantly higher incidence of disease recurrence in black patients relative to white patients (50% vs. 11%, p=0.012). Morbid obesity was associated with a higher rate of major flap loss or necrosis (50% vs. 6.25%, p=0.008). Adjuvant chemotherapy showed higher rates of major wound breakdown or dehiscence (6.7% vs. 3.8%, p=0.032), minor wound breakdown or dehiscence (40% vs. 4.7%, p=0.007), minor seroma or hematoma (20% vs. 0%, p=0.033) and presence of any minor complication (53.3% vs. 9.5%, p=0.003). Finally, adjuvant radiation therapy had a higher rate of incidence of any major complication (100% vs. 53%, p=0.033) and disease recurrence (66.7% vs. 13.3%, p=0.003)
Reconstruction of oncologic chest wall defects requires an understanding of anatomy and disease pathophysiology. Pedicled flap closure is often necessary for coverage of the wide resection margins. While local disease control remains the critical factor in disease prognosis, reconstruction of the resultant chest wall defects after neoplasm extirpation often carries a significant rate of post-operative complications.
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10:45 AM
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The ACS NS-QIP Risk Calculator as a Predictor for Post-Operative Complications in Microsurgery
Background: Peri-operative indexes such as the American College of Surgeons National Surgical Quality Improvement Program (ACS NS-QIP) have been widely used as an objective tool by surgical specialties to predict post-operative patient outcomes. This study aimed to determine the accuracy of ACS NS-QIP in predicting the rate of postoperative complications in patients with microsurgical free flap reconstruction.
Methods: A retrospective review of patients who underwent any microsurgical free flap reconstruction surgery between August 2019 to June 2021. Univariate analysis between complication and no complication groups were completed to identify significant differences between ACS NS-QIP risk percentages. Receiver operating characteristic (ROC) curves of ACS NS-QIP were synthesized using the risk percentage to predict complications in our population.
Results: A total of 79 patients were identified. The mean age of the cohort was 58.5 ± 12.7, mean BMI was 28.4 ± 6.6, where forty-one (52%) patients were men. On univariate analysis venous thromboembolism (p= 0.01) and any complication (p= 0.006) were found to be significant. Predictability of venous thromboembolism risk was found to have a diagnostic accuracy of 87.5% with an ACS NS-QIP percentage threshold of 2.5% that was associated with a sensitivity of 82.0% and specificity of 71.0%. ACS NS-QIP predicted any complication occurring with a diagnostic accuracy of 66.3% with an ACS NS-QIP threshold value of 22.4%, associated with a sensitivity of 69.2% and a specificity of 60.0%.
Conclusion: The ACS NS-QIP risk calculator may be a useful tool for surgeons to identify patients at increased risk for post-operative complications in microsurgery. This index's accuracy could be made stronger by increasing future incorporation of validated free flap preoperative risks and postoperative complications data to continue to direct better patient outcomes.
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10:50 AM
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Risk of autologous abdominal free flap breast reconstruction in Class 3 obese patients
Obesity is a well-known risk factor for postoperative complications in autologous breast reconstruction. Advancements in flap design and surgical timing of definitive reconstruction have all played a role in diminishing adverse outcomes1-3. The deep inferior epigastric perforator (DIEP) flap has become a workhorse in current breast reconstruction surgical therapies1,4. Despite continued research, there remains conflicting information regarding complications and outcomes in obese patients following DIEP flap reconstruction. To better identify complications and understand the effects of obesity in the setting of autologous breast reconstruction, we describe a single-center outcomes analysis of patients who underwent DIEP flap reconstruction. An initial cohort of 194 patients consisting of 332 DIEP flaps was retrospectively analyzed at the University of Nebraska Medical Center utilizing electronic medical records. Inclusion criteria included patients who have undergone DIEP flap breast reconstruction immediately, delayed-immediate, or delayed from the time of mastectomy. Data will be organized into five categories using World Health Organization (WHO) weight status by body mass index (BMI). BMI will be based on the day-of-surgery weight. Initial data analysis consisted of ANOVA and standard T-Test's evaluating surgical complications and surgical complications requiring procedural intervention between Class III obese patients and patients with a BMI < 40 kg/m2. Surgical complications that were recorded for analysis include seroma, hematoma, infection, fat necrosis, wound dehiscence, skin necrosis, abdominal hernia or bulge, and DVT or PE. Required interventions include surgical and procedural events in the postoperative course to address one of the complications listed above. No follow-up aesthetic interventions were included. Class III obese patients had a significantly higher mean number of postoperative complications, 2.15, compared to those with a BMI of less than 40, who had a mean number of 1.23 (p=0.0048). Additionally, the number of postoperative interventions required was significantly higher in Class III obese patients, at 1.38 vs. 0.42 in those with a BMI of less than 40 (p = 0.00011). The data presented suggest that a BMI greater than 40 poses a significant risk for complication and required intervention postoperatively. This can lead to further morbidity in a patient population that has largely undergone breast oncologic treatment before and/or after the DIEP procedure. This project is an attempt to guide future breast reconstruction surgery in obese patients to determine safety and outcome data postoperatively. Future directions include comparing surgical outcomes in delayed vs. immediate DIEP flap reconstruction as well as postoperative narcotic usage in those who completed the ERAS protocol at our institution.
- Heidekrueger PI, Fritschen U, Moellhoff N, et al. Impact of body mass index on free DIEP flap breast reconstruction: A multicenter cohort study. Journal of Plastic, Reconstructive and Aesthetic Surgery. 2021;74(8):1718-1724. doi:10.1016/j.bjps.2020.12.043
- Patterson CW, Palines PA, Bartow MJ, et al. Stratification of Surgical Risk in DIEP Breast Reconstruction Based on Classification of Obesity. Journal of Reconstructive Microsurgery. 2021;(class III). doi:10.1055/s-0041-1727202
- Papadakis M, Schuster F, Djedovic G, Rahmanian-Schwarz A. Super obesity is not necessarily a contraindication to deep inferior epigastric perforator flap breast reconstruction. BMJ Case Reports. 2018;2018:2017-2019. doi:10.1136/bcr-2017-223065
- Sultan SM, Seth AK, Lamelas AM, Greenspun DT, Erhard HA. Bipedicle-Conjoined Deep Inferior Epigastric Perforator Flaps for Unilateral Breast Reconstruction in Overweight and Obese Patients: Do the Benefits Outweigh the Risks? Journal of Reconstructive Microsurgery. 2020;36(5):346-352. doi:10.1055/s-0040-1701209
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10:55 AM
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Perioperative Characteristics and Postoperative Complications of Pediatric Clitoral Reconstruction
Clitoroplasty, or clitoral reconstruction, are performed in the pediatric population in cases of clitoral hypertrophy to return clitoral form and function. There have been no previous nationwide cohort studies of pediatric clitoral reconstruction. We aim to describe the perioperative characteristics and postoperative outcomes of patients that underwent pediatric clitoral reconstruction in the United States.
A retrospective cohort analysis was conducted using the National Surgical Quality Improvement Program Pediatric (NSQIP-P) database from 2012 to 2020. The database was queried using the CPT code 56805. All patients who underwent clitoral reconstruction were analyzed and descriptive statistics were collected.
111 female patients underwent clitoral reconstruction. The median patient age was 2.7 years (IQR 1.0 – 7.3). Most patients were ASA class 2 (62.6%), followed by ASA class 3 (28.8%) and ASA class 1 (9.0%). The mean (SD) length of total hospital stay was 1.9 days (1.7), and the total operation time was 210.9 minutes (112.3). Out of all the patients, 18.9% were born prematurely, and 16.2% exhibited minor to major cardiac risk factors. 82.7% had a congenital malformation, and 0.9% were underweight neonates (< 1500 grams) at the time of surgery. The most common diagnosis at the time of surgery was congenital adrenal hyperplasia (48.6%). The complication rate was 0.9% and was due to bleeding/transfusions. The readmission rate was 5.6%.
Overall, pediatric clitoral reconstruction is a safe procedure with low 30-day post-operative complication rates and an acceptable perioperative course. Further research into postoperative complications is essential to inform decision-making regarding the operative management approach.
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11:00 AM
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Safety and Function after VRAM Reconstruction for Proximal Lower Limb Defects: A 3-year Single Centre Case Series
Purpose:
The reconstruction of large complicated wound defects after soft tissue sarcoma extipiration of the proximal lower limb plays a vital role in the surgical outcomes for these patients [1]. This case series aims to summarize the utility of the vertical rectus abdominis musculocutaneous (VRAM) flap to reconstruct such complicated defects following wide resection of soft tissue sarcoma in the proximal lower limb.
Methods:
A 3-year mixed method, prospective-retrospective case series of 10 patients undergoing VRAM reconstruction for soft tissue sarcoma of the proximal lower limb (thigh and hip) from January 2020 to January 2022 at The Ottawa Hospital. Prospectively collected patient-reported outcomes included the Surgical Satisfaction Questionnaire (SSQ-8) to measure postoperative patient satisfaction and the Lower Extremity Functional Score (LEFS) to measure postoperative function [2,3]. Retrospectively collected outcomes included postoperative complications and recovery.
Results:
All 10 patients were ambulant, with limb functions fully restored regarding walking and gait following rehabilitation at 1-year postoperative follow-up. The overall reported function was excellent in all cases, with mean LEFS scores of 70.2 (out of 80 points), which was comparable among hip and thigh cases. All flaps showed complete survival and wound healing with no major complications requiring take-back to the OR. All patients reported feeling "very satisfied" or "satisfied" regarding postoperative pain control, recovery time, and surgical results on the SSQ-8.
Conclusion:
VRAM flaps provided reliable reconstructive success for coverage of large complex defects in the proximal lower limb of all patients after wide resection. The VRAM flap provides a large well-vascularized soft tissue flap that facilitates healing. The excellent functional and satisfaction outcomes are encouraging, and VRAM should be considered a reconstructive option in treating sarcoma after wide soft tissue resection.
References:
[1] Grinsell, D., Di Bella, C., & Choong, P. F. M. (2012). Functional Reconstruction of Sarcoma Defects Utilising Innervated Free Flaps. Sarcoma, 2012, 315190–315198. https://doi.org/10.1155/2012/315190
[2] Binkley, J. M., Stratford, P. W., Lott, S. A., & Riddle, D. L. (1999). The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Physical Therapy, 79(4), 371–383.
[3] Haff, R. ., Stoltzfus, J., Lucente, V. ., & Murphy, M. (2011). The Surgical Satisfaction Questionnaire (SSQ-8): A Validated Tool for Assessment of Patient Satisfaction Following Surgery To Correct Prolapse and/or Incontinence. Journal of Minimally Invasive Gynecology, 18(6), S49–S50. https://doi.org/10.1016/j.jmig.2011.08.171
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11:05 AM
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The Effect of Biologics on Surgical Healing and Postoperative Complications in Hidradenitis Suppurativa Patients
Introduction:
Hidradenitis suppurativa (HS) is a debilitating skin disease that leads to severe, painful lesions in the apocrine gland areas. Managing this disease is complex and often includes biologic therapy and surgery for severe disease. Studies have suggested that the use of both biologics and surgical intervention may enhance wound healing and reduce the risk of disease recurrence.1,2 However, a study by Worden et al suggests that continuing immune modulating therapy in the perioperative period may negatively impact wound healing.3 The purpose of this study is to analyze postoperative outcomes in patients who use perioperative biologic therapy for HS.
Methods:
This retrospective cohort study included patients who underwent surgery for HS at a single institution between January 1, 2013 and December 31, 2021. Chart review identified patient demographics, HS history, disease severity, surgery characteristics, and postoperative complications. Cohorts included patients who continued taking biologic therapy three months before surgery and those who did not. Our analysis focused on individual surgeries rather than individual patients and compared the presence of a surgery having at least one postoperative complication in the biologics and no biologics cohorts. Unadjusted Chi-square tests were used to evaluate the association between perioperative biologics and postoperative complications.
Results:
78 patients underwent surgery for HS with a total of 143 operations performed. 78 surgeries (55.2%) included patients who used biologics within three months before surgery. Within 30 days after surgery, there were no differences between the biologics and no biologics cohorts in patients that experienced at least one postoperative complication (p-value 0.26). Greater than 30 days after surgery, the biologics cohort had significantly more surgeries with at least one postoperative complication (p-value 0.03). Patients who used perioperative biologics had 2.53 greater odds of experiencing a disease flare, disease recurrence in the same anatomic site, and/or reoperation for a complication (95% CI 1.20-5.33, p-value 0.01). In the biologics cohort, there were no statistically significant differences in surgeries having any complications across all anatomic sites, surgical methods, and closures in the late postoperative period.
Conclusion:
Our study demonstrates that there are no statistically significant differences in postoperative complications between patients on perioperative biologic therapy and those who are not on biologic therapy in the immediate postoperative period. However, in the period greater than 30 days after surgery, patients on perioperative biologic therapy are more likely to experience a disease flare, disease recurrence in the same anatomic site, and/or may need a reoperation--irrespective of the anatomic site operated on, surgical method, and closure method. This may be due to more severe disease being masked by biologic therapy at the time of surgery, suggesting the need for deeper and wider excision of HS in patients continuing their biologic therapy to reduce postoperative complications. These results suggest that surgeons may not need to advise patients to discontinue their biologic therapy prior to surgery but should inform patients about the possibility of experiencing these complications in the late postoperative period.
References:
- Van Rappard DC, Mekkes JR. Treatment of severe hidradenitis suppurativa with infliximab in combination with surgical interventions: Correspondence. British Journal of Dermatology. 2012;167(1):206-208. doi:10.1111/j.1365-2133.2012.10807.x
- DeFazio MV, Economides JM, King KS, et al. Outcomes After Combined Radical Resection and Targeted Biologic Therapy for the Management of Recalcitrant Hidradenitis Suppurativa: Annals of Plastic Surgery. 2016;77(2):217-222. doi:10.1097/SAP.0000000000000584
- Worden A, Yoho DJ, Houin H, et al. Factors Affecting Healing in the Treatment of Hidradenitis Suppurativa: Annals of Plastic Surgery. 2020;84(4):436-440. doi:10.1097/SAP.0000000000002105
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11:10 AM
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Effectiveness of Risk Analysis Index Frailty Scores as a Predictor of Adverse Outcomes in Lower Extremity Reconstruction
Background: Frailty has been associated with increased postoperative morbidity and mortality. While calculating frailty is increasing in clinical significance, the effectiveness of its screening tools remains a challenge. This study evaluates the effectiveness of RAI-rev (Risk Analysis Index) at predicting adverse outcomes in lower extremity (LE) local and free flap reconstruction.
Methods: All LE local and free flap cases were obtained from the NSQIP database from 2015-2020. Demographics, perioperative factors, flap type, and 30-day outcomes were compared using student's t-test and Fisher's exact test. Frailty score was calculated for all cases using RAI-rev. Frailty scores were separated into increments from 15-35. The non-frail group is represented by scores <15 and the most-frail group by scores >35. Using the non-frail group as the reference, adjusted odds-ratios (aOR) for specific complications were calculated for each frailty score increment. Using chi-squared analysis, frailty scores for local flaps were compared to those for free flaps. Other variables of interest not included in the RAI-rev were collected, including COPD, diabetes, smoking, hypertension, BMI, steroid use, and wound class.
Results: We identified 270 local flap and 107 free flap cases. Univariate analysis of local flaps cases showed increased complications in patients with higher RAI scores, most notably deep surgical site infection (1% non-frail vs. 20% patients with RAI 31-35), stroke (0% non-frail vs. 17% most-frail), and mortality (0% non-frail vs. 17% most-frail). Local flap cases with RAI scores corresponding to the most-frail group were found to have an aOR of 51.0 (95% CI: 1.8 – 1402.5, p=0.02), 43.1 (95% CI: 1.6-1167.6, p=0.03), 6.8 (95% CI: 1.2-37.4, p=0.03) for stroke, mortality, and any complication respectively. While there were trends of higher rates of complications with higher RAI frailty scores in free flap patients, only sepsis had a statistically significant difference between the non-frail and most-frail patients (6% non-frail vs. 100% most-frail; aOR 42.3, CI: 1.45 – 1245.3, p=0.03). Average RAI score was significantly lower in patients receiving free flaps compared to local flaps (14.91 vs. 17.64, p=0.01).
Conclusion: Higher RAI-rev frailty scores, specifically score >35, were associated with increased complications in LE local flaps showing that the RAI-rev is a useful tool in predicting complications in patients undergoing LE local flaps. Patients undergoing LE free flap reconstruction had low RAI-rev frailty scores, highlighting that free flaps are less frequently offered to patients who are presumed to be of higher risk. This study showed that the RAI-rev can be used as a risk calculator in LE reconstruction to determine if patients are good candidates for limb salvage, or if amputation may be a better option.
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11:15 AM
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Breaking Barriers: Managing Stomal Stenosis After Continent Urinary Stoma Creation in Bladder Exstrophy
INTRODUCTION
Classic bladder exstrophy (CBE) is a rare genitourinary malformation, where management is focused on achieving urinary continence. If bladder capacity fails to increase, urinary diversion through a continent urinary stoma (CUS) must be considered. Stenosis of the catheterizable channel is the most frequent and feared complication as it is progressive and recurrent. Stomal stenosis (SS) is initially managed conservatively but if SS persists, dilation under anesthesia becomes necessary. If this is unsuccessful, scarred tissue is excised with healthy mucosa and skin re-approximated in a local tissue rearrangement (LTR).
The aim of this study was to identify causes, risk factors, and management strategies of SS amongst CBE patients that previously underwent CUS creation.
METHODS
CBE patients who underwent CUS were retrospectively reviewed for risk factors for SS including outcome of primary exstrophy closure, number of prior midline laparotomies, and suture material used during umbilicoplasty for securing the CUS to abdominal skin. SS was defined as difficulty self-catheterizing due to adhesions, hypertrophic scarring, or keloid formation. Conservative SS management included overnight catheterization, topical corticosteroids or triamcinolone acetonide (TAC) injections. Surgical management included stomal incision or scar excision with a LTR using either a V-Y advancement flap or Z-plasty. Success was defined as the ability to independently self-catheterize at last follow-up.
RESULTS
A total of 265 CBE patients underwent CUS creation at a mean age of 10.9 years. SS developed in 68 patients (25.7%) at a mean interval of 3.7 years after CUS creation (range, 0.1–19.2). Etiology included adhesions in 45 patients (66.2%), keloid in 16 (23.5%), and hypertrophic scar in 7 (10.3%). No difference in SS rates were observed by primary exstrophy closure success rates or number of prior midline laparotomies. Vicryl use for CUS creation was associated with an increased risk of SS compared to PDS (p=0.0025).
Of the 68 SS patients, conservative management was successful in 13.3% of adhesion and 4.3% of both hypertrophic scar and keloid patients. Most adhesion patients underwent stomal incision with a success rate of 88.2%. Stomal incision with TAC or stomal excision and LTR were successful in 62.5% and 53.8% of cases, respectively. Patients with hypertrophic scars or keloid (n=23), responded best with scar excision and LTR (60.0%) whereas only 16.7% achieved initial resolution after incision and TAC. At last follow-up, all patients achieved successful SS management.
CONCLUSIONS
SS is a common complication following CUS and represents a challenge for the reconstructive surgeon. Vicryl suture may increase risk of SS compared to PDS, perhaps due to monofilamentous suture inducing less hypertrophic scarring compared to multifilamentous suture. Patients with adhesions benefited most from stomal incision while patients with hypertrophic scarring or keloid require scar excision and marsupialization of healthy mucosa to healthy abdominal skin. Utilizing PDS may reduce the incidence of this complication and these management techniques may improve success from primary surgical repair.
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11:20 AM
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Reconstructive Session 4 - Discussion 1
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11:30 AM
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Surgical Management of Sirenomelia: A Case Study
Introduction
Sirenomelia is a rare congenital condition characterized by fusion of the lower limbs. Patients generally do not survive long after birth, as the condition is associated with multi-system organ dysfunction due to developmental anomalies. In surviving neonates, the levels of organ dysfunction and skeletal fusion determine how to proceed with therapy. However, considering the low incidence and few cases surviving the neonate period, there is minimal understanding surrounding the surgical management of Sirenomelia. We present a unique case of an infant born with Sirenomelia who not only survived the birth process, but at age 11 months, was determined to be a candidate for surgical separation of the lower extremities.
Report of Case
The patient is an 11-month-old female that was born with fusion of the lower limbs. Additional congenital malformations at the time of birth included an imperforate anus and a single perineal channel draining urine, with complete absence of external genitalia. Ultrasound demonstrated a right solitary kidney and no definitive bladder. Initial patient management revolved around investigating and intervening upon visceral and gastrointestinal issues, given their severity and potential lethality. After stabilization of the patient's other malformations, lower extremity separation could be addressed. First, a thorough pre-operative assessment was performed to assess feasibility and develop an approach for separation. CT imaging revealed no bony involvement of the fusion and adequate vasculature, indicative of type I Sirenomelia. This case was approached much like a dorsal rectangular flap syndactyly release. Large z-plasty flaps were designed and raised, and the soft tissue within the skin bridge was meticulously dissected to preserve anatomy and provide adequate skin flaps without perineal skin grafting. A quadrangular flap was designed to reconstruct the perineum and produce a neo-vulva using de-epithelization. At 15 months old, 4 months post-op, the incisions are well-healed and she continues to progress with physical activity and weight-bearing bilaterally.
Conclusions
Management of Sirenomelia is incredibly challenging. There is limited data to guide surgical management of affected patients. We performed a single-stage surgical separation in a surviving Sirenomelia patient, with good aesthetic and functional outcome. Medical comorbidity stabilization, multi-disciplinary care, and thorough pre-operative imaging are vital aspects of successful repair in these patients.
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11:35 AM
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Management of thoracic aortic graft infections with combined omental and bilateral pectoralis major flaps
Background: Following open replacement of the thoracic aorta, vascular graft infection is an infrequent but highly morbid complication, with reported mortality rates as high as 75%. Historically, surgical management has consisted of complete removal and re-replacement of the infected graft. However, several studies suggest vascularized tissue transfer may serve as an effective method for treating aortic graft infections, particularly in patients who may be unable to tolerate extended extra-anatomic bypass procedures required for total graft removal and re-replacement. In this study, we reviewed our experience with treating thoracic aortic graft infections with combined omental and bilateral pectoralis major myocutaneous (PMM) advancement flaps.
Methods: Records of 600 sternal wound reconstructions performed by the senior author (JAA) at a high-volume cardiac surgery center from 1996-2023 were reviewed. At the time of surgery, all patients underwent sternal hardware removal, debridement, and closure with bilateral pectoralis major (PMM) myocutaneous advancement flaps and pedicled omentum. Patients with clinical and/or radiographic signs of aortic graft infection were included.
Results: Complete data were available for 561 sternal wound reconstructions performed by the senior author during this period. Combined bilateral pectoralis and omental flaps were mobilized in 11 patients with aortic graft infections. 9/11 patients (81.9%) had an ASA score 4. At the time of index cardiac surgery, 11/11 (100%) patients underwent aortic root repair/replacement, and 9/11 (81.9%) patients also underwent aortic valve repair/replacement. Indications for sternal reconstruction included culture-positive wound infection (8/11; 72.7%), dehiscence (5/11; 45.5%), wound drainage (7/11; 63.6%), and inability to close the chest following the original sternotomy due to hemodynamic instability (5/11; 45.5%). At the time of chest exploration, 6/11 patients (54.5%) underwent complete removal and re-replacement of the infected aortic graft, compared to 5/11 patients (45.5%) who underwent graft-preserving mediastinal washout and debridement. Immediate flap closure was performed in 4/11 patients (36.4%) following graft replacement or mediastinal debridement. Notably, all patients required intraoperative vasopressor therapy during their flap reconstruction procedure. Intraoperative deep mediastinal cultures were positive in 3/11 patients (27.3%). Post-operative complications included partial dehiscence (1/11; 9.1%), seroma (2/11; 18.2%), hematoma (1/11, 9.1%), abdominal hernia (1/11; 9.1%), and recurrent infection (1/11; 9.1%). One patient (9.1%) died within 30 days of sternal reconstruction from tachyarrhythmia secondary to mitral valve failure. No patients have undergone operative re-intervention for perioperative flap-related complications, but one patient underwent elective resection of the omental flap 13 months postoperatively as it caused him discomfort and he did not like its associated bulge. None of the other patients had any aesthetic or functional complaints related to the flaps.
Conclusions: Patients with thoracic aortic graft infection all had significant preoperative systemic comorbidities. However, given overall low postoperative morbidity and mortality, we found treatment of these life-threatening aortic graft infections with combined omental and pectoralis major flaps to be safe and effective, particularly in patients who may be too frail to undergo complete graft excision procedures.
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11:40 AM
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The Orthoplastic Paradigm in pediatric lower extremity sarcoma: specialized skill sets operating in concert
Background: Plastic surgery participation in multidisciplinary surgical subspecialty care has been demonstrated to improve patient outcomes, decrease complications and length of hospital stay, and increase hospital revenue. The reconstructive skills of plastic surgeons are critical in optimizing functional outcomes in settings where injury or necessary ablative procedures can be otherwise devastating. This analysis aimed to characterize the institutional collaboration of plastic surgery and oncologic orthopaedic surgeons in the treatment of pediatric osteosarcoma.
Methods: A retrospective chart review of operating schedules was conducted for teams consisting of oncologic orthopaedic surgery and reconstructive plastic surgery at a large pediatric tertiary referral center. Data collection included patient demographics, case descriptions, diagnoses, neoplastic pathology, and contributions of surgeons to each case. Cases were sub-stratified by sarcoma location and analysis focused on the most prevalent location, the lower extremity. Descriptive statistics were used to quantify the distribution of sarcoma location and pathology, as well as characterize case involvement of reconstructive plastic surgery in operative treatment of pediatric sarcoma.
Results: 94 patients underwent sarcoma resection and functional reconstruction by an orthopaedic and plastic surgeon team in a 10-year period. 54 patients underwent combined ablative and reconstructive operations for lower extremity sarcoma at an average age of 16.6 ± 8.8 years. Total oncologic knee arthroplasty was the most prevalent procedure, performed in 20 patients and utilized for sarcomas located in the distal femur or proximal tibia. Plastic surgery involvement in oncologic arthroplasty primarily consisted of local pedicled flaps. 15 patients were identified in which osseus fibular free flaps were utilized in a modified-Capanna procedure, in which plastic surgery performed flap harvest, inset, and microsurgical anastomoses. Osseus free flaps were primarily used in cases with ablative defects in the long bone diaphysis. Local flap coverage was utilized in up to 65% of combined lower extremity orthopeadic oncology and reconstructive plastic surgery cases, and osseus free flaps were used in up to 30% of cases. Sarcoma recurrence, infection, chronic wounds, pathologic fractures, non-union, and hardware failure were prevalent in this primarily adolescent population, most of whom were immunosuppressed secondary to resuming chemotherapy regimens.
Conclusions: An 'Orthoplastic' approach has previously been suggested for severe limb injuries and diabetic foot ulcers. Osseus free flaps are critical to reconstruction of defects in the diaphysis and require the microsurgical skills of plastic surgeons, but tenets of plastic surgery have numerous applications and benefits in this setting beyond osseus flaps. Prevalence of sarcoma recurrence, non-union and hardware failure requires an individualized, thoughtful yet dynamic approach to reconstruction, a skillset intuitive to plastic and reconstructive surgeons. The Orthoplastic paradigm in the setting of pediatric oncologic reconstruction promotes a holistic approach to optimization of functional outcomes and quality-of-life considerations during and after cancer.
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11:45 AM
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The Evolution of PROs Following Limb-Salvage vs Amputation: An Analysis of LIMB-Q Data
Introduction:
Lower extremity traumatic injuries can be devastating events for patients. The impact on patients' lives is widespread and long-lasting. However, it is not well understood how patient-reported outcomes (PROs) evolve over time following limb-threatening lower extremity traumatic injuries. Our aim was to measure PROs in limb-salvage and amputation patients at various time points from injury.
Methods:
We performed a cross-sectional study of lower extremity trauma patients with injuries distal to the mid-femur from 25 countries requiring limb-salvage and/or amputation. Clinical, demographic, and PRO data were collected by patient self-report. PRO data was collected using the LIMB-Q, lower extremity trauma-specific PRO instrument. Primary outcomes were LIMB-Q Function, Symptoms, Life Impact, Psychological, Sexual Well-being, Work Life, and Decision Satisfaction scales. Patient and clinical characteristics were tested with ANOVA and controlled for with multivariate linear regressions. A predicted means with 95% confidence interval (CI) was generated for each regression model. Significance was set at p<0.05.
Results:
Data was collected in 385 patients. Mean time from injury to data collection was 8.4 years (SD 9.8, range: 0-58 years). Across treatment groups, mean time from injury to data collection was 7.6 years in the reconstruction group and 9.7 years in the amputation group. After controlling for patient and clinical characteristics, time from injury was negatively associated with Decision Satisfaction (p<0.001; 95% CI [-0.95, -0.38]. When stratified by treatment group, increasing time from injury was negatively associated with Decision Satisfaction (p<0.001; 95% CI [ -1.7, -0.5]) in limb-salvage patients only. There were no significant differences in the remaining scales at different time points from injury in either patient cohort.
Conclusion:
Decision-making following limb-threatening lower extremity injuries is complicated. The ideal treatment is not always clear. We found that following limb-salvage, but not amputation, patients reported higher levels of decision regret with increasing time from injury. Improved education and shared decision-making may be needed to address the high levels of decision regret over time in limb-salvage patients.
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11:50 AM
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Disparities in Lower Extremity Trauma Patients: Differences in the Experience of Receiving Care
PURPOSE
Healthcare disparities have been observed in patients with lower extremity trauma, including those undergoing limb-salvage and amputation. While it has been demonstrated that patients of racial and ethnic minority groups have worse clinical outcomes, it is not well understood if there are disparities in how patients receive care. Given the amount of patient education, counseling, and surgical decision-making required in the pre-operative care of patients with limb-threatening injuries, how patients experience care is important. Our primary aim was to identify disparities in how care is received by patients, specifically satisfaction with information, decision-making, and the patient-surgeon relationship.
METHODS
We conducted an international, cross-sectional study of patients following lower extremity trauma (fractures distal to mid-femur) from 10 countries. Clinical, demographic, and LIMB-Q data was self-reported. The LIMB-Q (0-100, higher = better) is a patient-reported outcome instrument designed for patients following lower extremity trauma. Primary outcomes were LIMB-Q Satisfaction with Decisions (measures decision regret), Satisfaction with Information, and Satisfaction with Surgeon scales. A multivariable linear regression model was used to determine associations between patient factors and LIMB-Q scores.
RESULTS
Data was collected from 645 patients (mean age 42 years [standard deviation 17], 62% cisgender male, 70% White, 46% United States residents), 36% underwent soft tissue reconstruction and 18% underwent amputation. In comparison to White patients, decision regret was worse in Asian and Pacific Islander patients (Beta: -17, 95% confidence interval (CI): -29 to -3.7, p = 0.012) as well as patients identifying as "Other" (Beta: -11, 95% CI: -20 to -2.3, p = 0.014). In comparison to cisgender men, decision regret was worse in patients identifying as transgender or nonbinary (Beta: -27, 95% CI: -46 to -7.5, p = 0.006). Patients were generally highly satisfied with their surgeon (median: 91, IQR: 86-100). However, in comparison to White patients, Asian and Pacific Islander patients reported less surgeon satisfaction (Beta: -24, 95% CI: -41 to -6.3, p = 0.008). No disparities by race, ethnicity, or gender identity were observed for Satisfaction with Information.
CONCLUSIONS
Limb-threatening lower extremity injuries are complex and require a significant amount of patient education and surgical decision making. We identified higher levels of decision regret and less surgeon satisfaction in racial and gender minority patients, specifically in patients who are Asian and Pacific Islander. Addressing disparities in the experience of receiving care is a potentially overlooked healthcare disparity in lower extremity trauma patients. In addition, addressing or preventing disparities in the experience of receiving care may have the potential to prevent disparities in long-term functional and quality-of-life outcomes in this patient population.
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11:55 AM
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A Propensity Score Analysis of Wound Complications following Revision Total Knee Arthroscopy (TKA) with Flap Coverage
Background: Despite advancements in total knee arthroplasty, devastating wound complications still occur and require revisions. For complex wounds, soft tissue flap coverage has been established as a valuable reconstructive option improving patients' reported outcomes and knee total range of motion. The purpose of this study is to analyze wound complications following flap coverage for revision total knee arthroplasties (rTKA) on the national level.
Methods: Patients who underwent rTKA from 2012-2020 were identified in the NSQIP database using CPT codes. The cohort was divided into two subgroups: patients who underwent rTKA with a pedicled or free flap and those who did not receive a flap. A propensity score was generated from patients' baseline characteristics. A multivariable logistic regression model adjusting for propensity scoring and wound classification at the moment of the surgical procedure was then constructed to assess differences in clinical outcomes.
Results: rTKA was performed in 33,922 encounters, 104 (0.3%) of which utilized a flap, including 99 pedicled and 5 free flaps. Patients who received flaps had poorer preoperative functional status, higher frailty scores and were more likely to have their surgical wound classified as contaminated or dirty/infected. Flap coverage was associated with lower odds of wound dehiscence (OR 0.24, 95% CI 0.08-0.77, p=0.016) and higher odds of wound infection (OR 3.27, 95% CI 1.5-7.12, p=0.003). Further, higher odds of reoperation were found in the group of patients who underwent flap reconstruction (OR 3.19, 95% CI 1.77-5.77, P<0.001) with 75% of documented surgical indications being infection.
Conclusion: Soft tissue flap coverage is used more often in the setting of large and infected wounds following TKA. Our study's findings evidenced higher wound infection rates among patients who underwent flap coverage, likely attributable to the complexity of the wounds being treated and the longer operative time compared to patients who did not require flap coverage. Thus, patients undergoing rTKA due to infection may receive treatment to optimize wound conditions before flap placement.
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Valeria Bustos Hemer, MD, MS, MPH
Abstract Co-Author
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Arriyan Dowlatshahi, MD
Abstract Co-Author
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Nicholas Elmer, MD
Abstract Co-Author
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Toni Engmann
Abstract Co-Author
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Jose Foppiani, Mudr.
Abstract Co-Author
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Angelica Hernandez, MD
Abstract Co-Author
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Bernard Lee, MD, MBA, MPH
Abstract Co-Author
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Samuel Lin, MD
Abstract Co-Author
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Lauren Valentine
Abstract Co-Author
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Allan Weidman
Abstract Presenter
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12:00 PM
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Association Between Authorship Position and Scientific Impact Among Reconstructive Microsurgery Studies
Background: Author experience is an important factor in publishing high-impact articles, but the individual influences of first and senior authors is unclear. This study utilizes the Relative Citation Ratio (RCR) Index to investigate the contributory role of authorship position on article impact in reconstructive microsurgery (RM).
Methods: A cross-sectional study was conducted with RM-related articles published in three high-impact Plastic Surgery (PS) journals between 2002 and 2020. A search strategy was conducted in PubMed to extract all relevant articles. A two-stage screening process was performed for study selection. First and senior authors were extracted along with their RCR information from NIH iCite. Unequal variance T-test and Chi-Squared test were used to assess differences between groups. A Spearman correlation was performed to evaluate relationships between authorship and article impact, and correlations were compared using a Fisher's z transformation.
Results: A total of 902 articles were analyzed, corresponding to 1,717 authors. There was a statistically significant difference in the weighted RCR between first and senior authors (91.77 first author vs 157.65 senior author, p<0.0001), as well as the mean RCR values (RCR (1.42 first author vs 1.53 senior author, p=0.0075). Senior authors also had a significantly higher number of publications compared to first authors (70.78 first author vs 110.90 senior author, p<0.0001). Both authorship positions' weighted RCR correlated with the paper's NIH percentile (r=0.22, p<0.0001 first author vs r=0.21, p<0.0001 senior author), and their correlations were not significantly different (p=0.71).
Conclusion: Senior authors represent more experience publishing high-impact articles within RM. However, while there is an association between author and article impact, neither authorship position plays a more significant role. These results likely reflect the role of senior authors as mentors and "chaperones" for first authors to build the experience needed to publish in high-impact PS journals.
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12:05 PM
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Microsurgical and Free Flap Reconstruction in Pediatric Burn Survivors: A Systematic Review
Purpose: Burn injuries in children may be devastating especially if they involve extensive debridement and subsequent reconstruction. Some burn injuries may require microsurgical or free flap reconstruction when locoregional options are unavailable. Though free flap reconstruction may improve function, complications after pediatric microsurgical and free flap reconstruction for burn injuries are not well-documented in the literature. Our goal was to conduct a systematic review to summarize microsurgical burn reconstruction in pediatric patients and pool complications in published studies.
Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses, we searched five databases for observational studies, case series, and case reports in English on postburn microsurgical reconstruction in acute (≤ 6 week) or late (> 6 week) phases. Human subjects < 18 years old at time of reconstruction in were included. Studies with animals, cadaver, and locoregional/pedicled flaps without use of the operating microscope were excluded. Patient demographics, burn information, flap data, and complications were extracted. Complications included death and cause of death, flap failure and causes of flap failure, arteriovenous thromboses, skin/flap necrosis, hematoma/seromas, surgical site infections, venous congestion, wound disruption (i.e. wound dehiscence or epidermolysis), or any other complication not previously mentioned. Data were analyzed with descriptive statistics on Microsoft Excel.
Results: Of 1,071 studies, 17 were included spanning 11 countries and 38 years (1982-2020). Studies were published by 17 authors across 14 unique institutions. There were 3 institutions (21.4%) in the United States, Hong Kong, and Turkey that published 2 studies each. Included were 49 patients encompassing 27 males (55.1%) and 22 females (44.9%) with median age 8 [Interquartile range 7, 10] years. A total of 62 flaps were used to reconstruct 61 recipient sites in acute (n=11, 17.7% of flaps) and late phases (n=51, 82.3% of flaps). Most burns were thermal (n=25 injuries, 46.3%) and most flaps were anterolateral thigh (ALT, n=34 flaps, 54.8%) transferred to the head & neck (n=13, 38.2% of ALT flaps) and upper extremity (n=13, 38.2% of ALT flaps). There were 15 complications (30.6% of patients) with zero deaths or thromboses. Complications included 3 flap failures (6.1% of patients), 3 episodes of wound dehiscence (episodes, 6.1% of patients), 2 episodes of flap necrosis (4.1% of patients), 2 episodes of venous congestion (4.1% of patients), 2 unplanned returns to the operating room (4.1% of patients), 1 recipient site seroma (2% of patients), 1 skin ulcer at recipient site (2% of patients) at 1 year post-reconstruction, and 1 surgical site infection (2% of patients). The two unplanned returns to the operating room were for venous congestion and both flaps survived.
Conclusions: Our systematic review of postburn microsurgical and free flap reconstruction in the pediatric population identified a complication rate of 30.6% in published studies. There were no reported deaths. Optimizing techniques and postoperative management with an interdisciplinary burn and reconstruction team may lower complications for pediatric burn survivors who may greatly benefit from reconstructive surgery.
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12:10 PM
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The Impact of Perioperative Blood Transfusion on Flap Survival in Lower Extremity Trauma
Purpose: Blood transfusion may be life-preserving and necessary for adequate flap perfusion for hemorrhaging trauma patients. The impact of transfusion on free flap survival in breast reconstruction has been noted in the literature (1), but further investigation is needed in a trauma setting, where transfusions are critical for stabilizing patients. This study evaluates the effect of blood transfusions on postoperative flap complications in traumatic lower extremity (LE) reconstruction.
Materials and Methods: This retrospective review identified patients who underwent microsurgical LE reconstruction following trauma at a level I trauma center from 2007-2022. Clinical, perioperative, and blood transfusion data since admission were collected. Flap complications included flap revisions, partial flap necrosis, and flap loss. Chi-squared test, independent t-test, and multivariate logistical regression were used to analyze the collected data.
Results: Upon review, 350 LE flap patients were identified, of which 147 received blood transfusions (Tf+) and 203 received no blood transfusions (Tf-). Age, gender, hypertension, diabetes mellitus, previous injury to the same LE, and flap composition and location did not significantly vary between cohorts. Compared to the Tf- cohort, significantly more flaps in the Tf+ cohort suffered from partial flap necrosis (12.3% vs 5.9%, p=0.034), flap loss (7.5% vs 2.9%, 0.049), and any flap complication (21.2% vs 11.8%, p=0.016). Overall flap survival across both cohorts was 95.1%. Upon logistic regression, blood transfusion status (odds ratio [OR]: 2.13; p=0.027) and female gender (OR: 2.27; p=0.036) were identified as independent predictors of any flap complication. Follow-up time after discharge was 4.3±8.2 months, with no significant variation between cohorts.
Conclusion: Our study determined that perioperative blood transfusion resulted in a higher incidence of postoperative partial-to-full flap necrosis. These results indicate that the decision to transfuse should be made cautiously and strategically, limiting transfusion to only life-threatening cases to minimize morbidity and flap loss.
References:
1. Karamanos E, Shah AR, Kim JN, Wang HT. Impact of Blood Transfusion in Free Flap Breast Reconstruction Using Propensity Score Matching. J Reconstr Microsurg. 2021 May;37(4):315-321. doi: 10.1055/s-0040-1716388. Epub 2020 Sep 6. PMID: 32892332.
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12:15 PM
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The Impact Of Free Flap Harvest Laterality On Ambulatory Function In Lower Extremity Traumatic Reconstruction
Purpose: Free flaps are essential for limb salvage in patients with lower extremity (LE) trauma; however, significant donor-site morbidity could impact functional outcomes. This study compares postoperative ambulatory function between contralateral and ipsilateral free flap harvest in LE traumatic reconstruction.
Materials and Methods: A retrospective review was performed on patients who underwent LE reconstruction at a level 1 trauma center from 2009-2022. Flap characteristics, injury history, and ambulatory function were collected. Flap harvest laterality was determined in relation to the wounded leg. The flaps were categorized as either fasciocutaneous or those that included a muscle component (muscle/myocutaneous). Chi-squared and Mann-Whitney tests were used for statistical analysis.
Results: Upon review, 105 LE free flaps were performed, of which 70 (66.6%) were harvested from the ipsilateral leg and 35 (33.3%) were from the contralateral leg. Full ambulation was achieved in 29 (41.4%) patients in the ipsilateral cohort and 14 (40.0%) in the contralateral cohort (p=0.888). Average time to full ambulation did not vary between these cohorts (p=0.174). However, upon subanalysis of the 61 muscle/myocutaneous flaps, the ipsilateral cohort had prolonged time to full ambulation (9.8±8.4 months) compared to the contralateral one (3.3±2.6 months; p=0.016). There was no significant difference in time to full ambulation between flap harvest laterality cohorts among the fasciocutaneous flaps (p=0.733).
Conclusion: Among free flaps harvested from the ipsilateral leg, fasciocutaneous flaps promoted faster recovery to full ambulation than muscle/myocutaneous flaps. Surgeons may consider harvesting from a donor site on the contralateral leg if the flap reconstruction requires a muscle component.
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12:20 PM
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Reconstructive Session 4 - Discussion 2
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