Association between genital gender-affirming surgery and psychiatric comorbidities in individuals with gender incongruence.

BACKGROUND: Previous studies present mixed evidence on the relationship between psychiatric comorbidities and genital gender-affirming surgery (GGAS) in individuals with gender incongruence (GI). AIM: This research aims to investigate the psychiatric comorbidity rates post-GGAS in the GI population-namely, depressive disorders, anxiety disorders, posttraumatic stress disorders, substance abuse disorder, and suicidality. METHODS: Based on the TriNetX health care database, an international database with >250 million patients, a cross-sectional study was executed comparing psychiatric comorbidity rates among cases of GI with and without GGAS. Individuals were matched for demographic and health-related variables, which included history of cardiovascular disease, diabetes, and obesity. OUTCOMES: The main focus was to establish the rates and changes in psychiatric comorbidities following GGAS. RESULTS: Among individuals with GI, the study identified 4061 with GGAS and 100 097 without. At 1 year post-GGAS, there was a significant decrease in depression (odds ratio [OR], 0.748; 95% CI, 0.672-0.833; P < .0001), anxiety (OR, 0.730; 95% CI, 0.658-0.810; P < .0001), substance use disorder (OR, 0.730; 95% CI, 0.658-0.810; P < .0001), and suicidality (OR, 0.530; 95% CI, 0.425-0.661; P < .0001), and these reductions were maintained or improved on at 5 years, including posttraumatic stress disorder (OR, 0.831; 95% CI, 0.704-0.981; P = .028). CLINICAL IMPLICATIONS: The findings indicate that GGAS may play a crucial role in diminishing psychiatric comorbidities among individuals with GI. STRENGTHS AND LIMITATIONS: This is the largest known study to evaluate the effect of GGAS on psychiatric comorbidities in the GI population, offering robust evidence. The reliance on the precision of CPT and ICD-10 codes for data extraction poses a limitation due to potential coding inaccuracies. CONCLUSION: The evidence suggests a significant association between GGAS and reduced psychiatric comorbidities in individuals with GI.

Continuing Insurance Coverage for Flap-Based Breast Reconstruction: Is There a Reservation Cost Related to a Woman's Abdominal Flap Choice?

BACKGROUND: The recent proposed alterations to the Centers for Medicare and Medicaid Services regulations, although subsequently reversed on August 21, 2023, have engendered persistent concerns regarding the impact of insurance policies on breast reconstruction procedures coverage. This study aimed to identify factors that would influence women's preferences regarding autologous breast reconstruction to better understand the possible consequences of these coverage changes. METHODS: A survey of adult women in the United States was conducted via Amazon Mechanical Turk to assess patient preferences for breast reconstruction options, specifically deep inferior epigastric perforator (DIEP) and transverse rectus abdominis myocutaneous (TRAM) flap surgery. The Cochrane-Armitage test evaluated trends in flap preferences concerning incremental out-of-pocket payment increases. RESULTS: Of 500 total responses, 485 were completed and correctly answered a verification question to ensure adequate attention to the survey, with respondents having a median (interquartile range) age of 26 (25-39) years. When presented with the advantages and disadvantages of DIEP versus TRAM flaps, 78% of respondents preferred DIEP; however, as DIEP's out-of-pocket price incrementally rose, more respondents favored the cheaper TRAM option, with $3804 being the "indifference point" where preferences for both procedures converged (P < 0.001). Notably, respondents with a personal history of breast reconstruction showed a higher preference for DIEP, even at a $10,000 out-of-pocket cost (P = 0.04). CONCLUSIONS: Out-of-pocket cost can significantly influence women's choices for breast reconstruction. These findings encourage a reevaluation of emergent insurance practices that could potentially increase out-of-pocket costs associated with DIEP flaps, to prevent cost from decreasing equitable patient access to most current reconstructive options.

The Effects of Body Mass Index on Postoperative Complications in Patients Undergoing Autologous Free Flap Breast Reconstruction.

BACKGROUND: The prevalence of obesity in the United States exceeds 40%, yet perioperative effects of higher body mass index (BMI) in autologous breast reconstruction remain poorly studied. The purpose of this study was to investigate BMI's impact on postop complications in abdominal and gluteal-based autologous breast reconstruction. METHODS: We conducted a retrospective study using TriNetX, a health care database containing de-identified data from more than 250 million patients. Patients undergoing autologous breast reconstruction were identified by Current Procedural Terminology codes. Four cohorts were established by BMI class: <24.99, 25 to 29.99, 30 to 34.99, and 35 to 39.99 kg/m2. Outcomes of interest were defined by International Classification of Diseases,Tenth Revision (ICD-10) codes. A two-sample t-test was performed to compare incidence of postoperative complications between cohorts within 3 months of surgery. Patients with a BMI < 24.99 kg/m2 served as the control. Cohorts were balanced on age, race, and ethnicity. RESULTS: We identified 8,791 patients who underwent autologous breast reconstruction. Of those, 1,143 had a BMI < 24.99 kg/m2, 1,867 had a BMI of 25 to 29.99 kg/m2, 1,396 had a BMI of 30 to 34.99 kg/m2, and 559 had a BMI of 35 to 39.99 kg/m2. Patients with a BMI of 25 to 29.99 kg/m2 had a significantly increased risk of cellulitis. Patients with a BMI of 30 to 34.99 and 35 to 39.99 kg/m2 had a significantly increased risk of cellulitis, surgical site infection, need for debridement, wound dehiscence, and flap failure. CONCLUSION: Our study illustrates that there is an increased risk of postoperative complications associated with higher BMI classes. Understanding these data are imperative for providers to adequately stratify patients and guide the procedural decision-making.

Trends in Gender-Affirming Surgeries in the United States from 2010 to 2021.

Introduction: In 2017, an estimated 1.6 million adults and 150,000 teenagers identified as transgender in the United States. With ever-changing legislative developments regarding health care benefits for this population and the increasing number of patients presenting for gender-affirming surgery (GAS), there is a scarcity of literature on the temporal trends within the past decade. The objective of this study was to examine the temporal trends of the utilization of GAS. Methods: We conducted a cross-sectional study using TriNetX, a federated research network containing deidentified aggregate patient data. Using International Code of Disease (ICD) and Current Procedural Terminology (CPT) codes, we identified patients with a diagnosis of gender dysphoria who underwent GAS from 2010 to 2021. Basic demographic information and complications were analyzed. Complications of interest included site failure, infection, and systemic complications. Results: We identified a total of 8,403 patients who underwent GAS between January 2010 and December 2021. The number of procedures per year increased nearly 500% between 2016 and 2021 from 421 procedures to 2,224 procedures. Our demographic results were consistent with previous survey-based studies. The average age of patients who underwent masculinizing surgeries was consistently younger than those who underwent feminizing surgeries. Most patients undergoing GAS were of white race. The overall complication rate was 4.7%. Conclusion: In conclusion, our study reveals a significant and rapid rise in the utilization of GAS in the United States, with a fivefold increase in procedures between 2016 and 2021. The demographic characteristics and low complication rates observed highlight the evolving landscape of health care for transgender individuals and the need for ongoing assessment and support in this field.

Perforator Characteristics and Impact on Postoperative Outcomes in DIEP Flap Breast Reconstruction: A Systematic Review and Meta-Analysis.

BACKGROUND: High-quality evidence on perforator selection in deep inferior epigastric perforator (DIEP) flap harvesting is lacking, making preoperative planning and choice of perforators "surgeon-specific." This lack of consensus is a subject of continuous debate among microsurgeons. We aimed to systematically review perforator characteristics and their impact on DIEP flap breast reconstruction outcomes. METHODS: We conducted a systematic review and meta-analysis across six databases: ClinicalTrials.gov, Cochrane Library, Medline, Ovid Embase, PubMed, and Web of Science for all studies on DIEP flap breast reconstruction focused on perforator characteristics-caliber, number, and location. The primary goal was to analyze the impact of perforator characteristics on partial and/or total flap failure and fat necrosis. Data was analyzed using RevMan V5.3. RESULTS: Initial search gave us 2,768 articles of which 17 were included in our review. Pooled analysis did not show any statistically significant correlations between partial and/or total flap failure and perforator number, or perforator location. Sensitivity analysis accounting for heterogeneity across studies showed that, the risk for fat necrosis was significantly higher if single perforators (relative risk [RR] = 2.0, 95% confidence interval [CI] = 1.5-2.6, I 2 = 39%) and medial row perforators (RR = 2.7, 95% CI = 1.8-3.9, I 2 = 0%) were used. CONCLUSION: Our findings suggest that a single dominant perforator and medial row perforators may be associated with higher risk of fat necrosis after DIEP flap breast reconstruction. Adopting a standardized perforator selection algorithm may facilitate operative decision making, shorten the learning curve for novice surgeons, and optimize postoperative outcomes by minimizing the burden of major complications. This in turn would help improve patient satisfaction and quality of life.

Macromastia and Reduction Mammaplasty: Analysis of Outpatient Cost of Care and Opioid Consumption at 5 Years Postoperatively.

BACKGROUND: Macromastia is associated with increased opioid consumption, which could potentially be the initial exposure for patients with an opioid use disorder amid an escalating opioid crisis in the United States. OBJECTIVES: The purpose of this study was to evaluate outpatient cost of care and opioid consumption in patients with macromastia and compare those who underwent reduction mammaplasty vs those who did not have surgery. METHODS: PearlDiver, a database encompassing a national cohort of private payers with 153 million unique patients, was queried. The study cohort included patients diagnosed with macromastia who did or did not undergo reduction mammaplasty utilizing both ICD-9 and ICD-10 and CPT codes. Outpatient cost of care and morphine milligram equivalents (MME) were calculated up to 5 years postoperatively for both cohorts. RESULTS: At 1 to 3 years postoperatively, there was no statistically significant difference in outpatient cost of care between cohorts. At every follow-up thereafter, outpatient cost of care was higher among macromastia patients who did not undergo reduction mammaplasty, with cohort differences of US$240.68 and US$349.90 at 4 years and 5 years, respectively (P < .05). MME consumption was greater in patients who underwent reduction mammaplasty up to 30 days postoperatively (P < .01). Beyond that, there was no significant difference in MME consumption between cohorts. However, patients who did not undergo surgery had opioid consumption levels above 50 MME/day until 3 years after diagnosis of macromastia. CONCLUSIONS: Patients with macromastia who undergo reduction mammaplasty have lower outpatient care costs than patients who do not undergo reduction mammaplasty, with safer long-term opioid consumption in alignment with current Centers for Disease Control and Prevention guidelines.

Opioid-Prescribing Patterns in Body Contouring Surgery.

BACKGROUND: The United States is experiencing the highest opioid overdose death rate in our nation's history. Misuse and addiction to opioids, including prescription pain relievers, is a serious national crisis that affects public health as well as social and economic welfare. OBJECTIVES: The aim of the study was to critically evaluate postoperative opioid-prescribing patterns. METHODS: The PearlDiver database (Colorado Springs, CO) was queried for body contouring patients from 2010 to 2020. We identified patients that underwent panniculectomy, abdominoplasty, brachioplasty, thighplasty, mastopexy, breast augmentation, breast reduction, and liposuction for analysis. We subsequently analyzed the opioid use, with a focus on comorbid conditions and complications that are associated with increased use of opioids. RESULTS: A total of 56,773 patients underwent body contouring surgery. The most common opioid prescribed was hydrocodone with acetaminophen (37,017 patients). Average days of therapy was 17.92 days. Comorbid conditions and postoperative complications were examined for risk of increased opioid prescriptions. Patients with peripheral vascular disease and smoking were prescribed significantly more morphine milliequivalents (MME) of opioids than patients without peripheral vascular disease (871.97 vs 535.41; P < .001) and smoking (1069.57 vs 440.84; P < .001). Patients who developed surgical site infection, disruption of wound, and venous thromboembolism were prescribed a significantly higher MME of opioids (1213.63 vs 561.59; P < .001). CONCLUSIONS: Our data provide information on opioid prescription patterns in the body contouring population, with focused review of comorbid conditions and complications in relation to opioid-prescribing patterns. We hope that the data will improve opioid prescription habits among plastic surgeons in the setting of a global opioid crisis.

Analysis of Complications in Patients With a History of Cannabis Use and Tobacco Use Undergoing Implant-Based Breast Reconstruction.

BACKGROUND: There is limited information regarding the perioperative effects of marijuana in breast reconstructive surgeries. OBJECTIVES: The objective of this study was to explore the association between a history of cannabis use and postoperative complications in the setting of implant-based breast reconstruction. METHODS: Two databases, TriNetX and PearlDiver, were queried for patients undergoing implant-based breast reconstruction. Patients were divided into 4 groups based on active ICD-10 diagnostic codes: (1) cannabis use only, (2) tobacco use only, (3) cannabis and tobacco use, and (4) neither cannabis nor tobacco use. Associations with postoperative complications were analyzed with a logistic regression test. RESULTS: TriNetX search revealed that 327 patients had an active diagnosis of cannabis use only and 1118 had an active diagnosis of tobacco use only. Patients in the cannabis only cohort had a significantly increased risk of developing surgical site infection. Patients in the tobacco only cohort had significantly increased risk of developing wound dehiscence, need for debridement, and surgical site infection. The PearlDiver search included 472 patients who had an active diagnosis of both cannabis and tobacco use and 17,361 patients with a diagnosis of tobacco use only. Patients with a diagnosis of cannabis and tobacco use had a significantly increased risk of developing postoperative complications including surgical site infection, wound dehiscence, need for incision and drainage, and debridement. CONCLUSIONS: Patients undergoing implant-based breast reconstruction with an active diagnosis of cannabis with or without tobacco use were at increased risk of developing postoperative complications, and the risk was even higher in patients using both tobacco and cannabis.

Telehealth: Could It Be an Avenue to Microvascular Breast Reconstruction for Patients with Geographical Barriers?

BACKGROUND: All women undergoing a mastectomy have the right to reconstruction. However, many women do not receive reconstruction and many more are not aware of all the reconstructive options available to them. Travel distance to a center that provides reconstruction and subsequent follow-up may be a contributing factor to this disparity especially among those who seek microsurgical options. Telehealth, which provides patients with remote video consultations and decreases the travel burden, may be a solution to optimize the accessibility of breast reconstruction for these patients. The purpose of this study was to discuss the efficacy and reliability of telehealth to overcome geographic barriers. METHODS: Patients who received breast reconstruction and participated in video telehealth visits between February and May 2020 were included in this study. Patient demographics, comorbidities, and clinical outcomes were collected. Video telehealth encounters were reviewed to determine specific concerns and questions discussed during these encounters. RESULTS: A total of 235 breast reconstruction surgery patient encounters were recorded for 4 plastic surgeons who offer microsurgical breast reconstruction. Eighty-eight patients (37.4%) were seen as telehealth visits, 20 (22.7%) of which were new patient visits. Eight (9.09%) patients were microsurgical breast reconstruction candidates and 25 (28.4%) were following-up after microsurgical breast reconstruction. The majority of telehealth visits included normally healing wounds in the postoperative patient. CONCLUSION: Telehealth provides an avenue for premastectomy consultation, second opinion visits, and postoperative follow-up for patients who have geographical barriers precluding them from reaching plastic surgeons who perform all types of breast reconstruction.

Is Vascularized Composite Allograft Transplantation Experimental or an Accepted Surgical Procedure: Results from a National Survey.

BACKGROUND: More than 85 patients have received over 100 hand/arm transplants and more than 35 patients have received full or partial face transplants at institutions around the world. Given over two decades of experience in the field and in the light of successful outcomes with up to 17 years follow up time, should we still consider vascularized composite allograft (VCA) as a research/clinical investigation? We present the results of a nationwide electronic survey whose intent was to gather institutional bias with regard to this question. METHODS: An 11 question survey that was developed by VCA advisory committee of American Society of Transplantation was sent to all identified Internal Review Board chairs or directors in the United States. RESULTS: We received a total of 54 responses (25.3%) to the survey. The majority (78%) of responses came from either the chairperson, director, or someone who is administratively responsible for an IRB. CONCLUSION: Though certainly not an exhaustive investigation into each institution's preference, we present a representative sampling. The results of which favor VCA as an accepted clinical procedure given the appropriate setting. Further research is needed to fully ascertain practices at each individual institution.

Changes to Venous Flow Coupler Signal during DIEP Flap Inset Can Be Predictive of Poor Clinical Outcomes in Autologous Breast Reconstruction.

BACKGROUND: Venous flow couplers are typically used to monitor free flaps during the postoperative period, with a continuous venous signal available immediately after completion of the anastomosis. Intraoperative loss of the coupler signal is not uncommon and may require adjustments in free flap inset and even flap thickness to get the venous signal to return. The effects of intraoperative coupler signal loss and the role of this technology on flap outcomes have not been evaluated. We hypothesized that the use of intraoperative coupler can be protective of both early and late flap complications by preventing unfavorable flap insets. PATIENTS AND METHODS: All patients who underwent free flap breast reconstruction between January 2018 and June 2019 by single microsurgery team were included. Flap inset and inset changes based on flow coupler signal problems were reviewed in the procedure notes. Patient demographics data and clinical outcomes were analyzed with comprehensive chart review. RESULTS: Forty-four consecutive patients with 69 free flaps were identified. There were no significant differences in patient characteristics or venous coupler size used in venous anastomosis. Although the number of operating room take backs for venous insufficiency was not significantly different between two groups, the free flaps with inset change had significantly higher complications that required later surgical intervention (p = 0.0464). CONCLUSION: Surgeons should be aware that intraoperative coupler signal loss can be associated with poor clinical outcomes postoperatively and these flaps may require more perfusion imaging, flap debulking, or even additional venous anastomosis.

Patient Safety in Microvascular Plastic Surgery.

Patient safety is defined as freedom from accidental or preventable harm produced by medical care. The identification of patient- and procedure-related risk factors enables the surgical team to carry out prophylactic measures to reduce the rate of complications and adverse events.The purpose of this review is to identify the characteristics of patients, practitioners, and microvascular surgical procedures that place patients at risk for preventable harm, and to discuss evidence-based prevention practices that can potentially help to generate a culture of patient safety.

Comparison of Synthetic and Biologic Mesh in Ventral Hernia Repair Using Components Separation Technique.

Ventral hernia repair (VHR) for large abdominal wall defects is challenging. Prior research established that the use of mesh is superior to suture closure alone and that component separation is an effective technique to combat loss of abdominal domain. Studies comparing component separation technique (CST) outcomes utilizing synthetic versus biologic mesh are limited. A retrospective review was conducted of 72 consecutive patients who underwent VHR with CST between 2006 and 2010 at our institution. Surgeon preference and the presence of contamination guided whether synthetic mesh (27 patients) or biologic mesh (45 patients) was used. Mean follow-up interval for all comers was 13.9 months and similar in both groups (P > 0.05). Degree of contamination and severity of premorbid medical conditions were significantly higher in the biologic mesh group, as reflected in the higher Ventral Hernia Working Group (VHWG) score (2.04 versus 2.86). Clinical outcomes, as measured by both minor and major complication rates and recurrence rates, were not significantly different. Minor complication rates were 26% in the synthetic group and 37% in the biologic group and major complication rates 15% in the synthetic group and 22% in the biologic group. There was 1 recurrence (4%) in the synthetic mesh group versus 5 (11%) in the biologic mesh group. Multivariable analysis for major complications revealed no significant difference for either synthetic or biologic mesh while controlling for other variables. Subset analysis of uncontaminated cases revealed recurrence rates of 4% in the synthetic mesh group and 6% in the biologic mesh group. VHR using CST and either synthetic mesh or biologic mesh resulted in low recurrence rates with similar overall complication profiles, despite the higher average VHWG grading score in the biologic mesh group. Our results support the VHWG recommendation for biologic mesh utilization in higher VHWG grade patients. In VHWG grade 2 patients, our clinical outcomes were similar, supporting the use of either type of mesh.

Stable mixed hematopoietic chimerism permits tolerance of vascularized composite allografts across a full major histocompatibility mismatch in swine.

This study tested the hypothesis that vascularized composite allografts (VCA) could be accepted in a robust model of hematopoietic chimerism by injecting allogeneic bone marrow cells (BMC) into swine fetuses. Outbred Yorkshire sows and boars were screened to ensure the absence of the major histocompatibility (MHC) allele SLA(cc) of inbred MGH miniature swine and then mated. Bone marrow harvested from an SLA(cc) swine donor was T-cell depleted and injected intravenously into the fetuses between days 50-55 of gestation. After birth, the piglets were studied with flow cytometry to detect donor cells and mixed lymphocyte reactions (MLR) and cell-mediated lympholysis (CML) assays to assess their response to donor. Donor-matched VCAs from SLA(cc) donors were performed on four chimeric and two nonchimeric swine. The results showed donor cell engraftment and multilineage macrochimerism after the in utero transplantation of adult BMC, and chimeric animals were unresponsive to donor antigens in vitro. Both control VCAs were rejected by 21 days and were alloreactive. Chimeric animals accepted the VCAs and never developed antidonor antibodies or alloreactivity to donor. These results confirm that the intravascular, in utero transplantation of adult BMC leads to donor cell chimerism and donor-specific tolerance of VCAs across a full MHC barrier in this animal model.

Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction.

BACKGROUND: Prosthetic reconstruction using human acellular dermis (ADM) is a common practice in breast reconstruction. AlloDerm and FlexHD are two different forms of ADM, each with unique characteristics. No studies have directly compared the postoperative complications of these 2 products. METHODS: The outcomes of 547 consecutive implant-based breast reconstructions were reviewed. RESULTS: Reconstruction was performed in 382 consecutive women (547 total breasts), employing mostly immediate reconstruction (81%). Mean follow-up was 6.4 months. Among immediate reconstructions, 165 used AlloDerm and 97 used FlexHD. Complications were similar by univariate analysis. In multivariate analysis, smoking and higher initial implant fill were risk factors for delayed healing. The use of FlexHD, single-stage reconstruction, and smoking were independent risk factors for implant loss. CONCLUSIONS: There is no significant difference in the complication rates between AlloDerm and FlexHD in immediate breast reconstruction. Multivariate analysis suggests that FlexHD may be a risk factor for implant loss.

Patient Satisfaction Using BREAST-Q and Breast Implant Illness after Breast Reconstruction in Transwomen.

Background: Gender-affirming breast augmentation comprises an increasing portion of breast augmentations performed by plastic surgeons. Satisfaction and breast implant illness (BII) symptoms in this population have not been well studied. This study aimed to evaluate satisfaction and BII symptoms in transwomen who received nontextured implants as part of their breast reconstruction. Methods: We conducted a retrospective review of transwomen who underwent breast augmentation for gender-affirming surgery. We performed telephone survey evaluation using the BREAST-Q questionnaire preoperatively, 6 months and 1 year after breast implant placement. Survey evaluation asking about BII symptoms was also administered at the same time points. Results: Twenty-six patients completed the BREAST-Q survey, which demonstrated significantly improved satisfaction postoperatively at 6 and 12 months when compared with median preoperative scores for psychosocial (P < 0.001; P < 0.001), sexual (P < 0.001; P < 0.001), and overall satisfaction with breasts (P < 0.001; P < 0.001). Physical well-being of the chest decreased at 6 months (P < 0.001) but improved in comparison with 12 months (P < 0.001). Thirty-four patients completed the BII survey, with 18% reporting symptoms at 3 months and 29% at 1 year. Zero patients requested explantation. Conclusions: Transwomen exhibit a significant increase in breast, psychosocial, and sexual well-being after breast augmentation. However, patients experienced a decreased physical well-being, and many report symptoms associated with BII. These results can be used to better counsel these individuals preoperatively and set reasonable postoperative expectations. Further studies investigating long-term satisfaction in larger cohorts are needed.

The use of flaps for management of deep sternal wound complications: A systematic review and meta-analysis.

BACKGROUND: Many options are available for reconstruction after deep sternal wound infections. However, these options have not been critically appraised. The aim of this systematic review and meta-analysis was to assess the existing evidence on sternal rewiring versus flap reconstruction and pectoralis major muscle flaps (PMFs) versus greater omental flaps (GOFs). METHODS: A systematic review and meta-analysis was performed. CENTRAL, MEDLINE and EMBASE were searched. Outcomes of interest included mortality, treatment failure and length of hospital stay (LOS). RESULTS: Fourteen studies were included. Nine studies compared flaps to rewiring, reporting on 618 patients. Patients treated with flaps had significantly lower mortality compared with patient treated with rewiring (Risk ratio [RR] 0.42, 95% confidence interval [CI]: 0.23-0.77, P < 0.01). Flap patients had significantly lower treatment failure compared with those who were treated with rewiring (RR 0.22, 95% CI: 0.14-0.37, P < 0.01). No statistically significant differences were observed in LOS between patients treated with flaps compared those treated with rewiring (standard mean difference -0.84, 95% CI: -1.91 to 0.24, P = 0.13). Five studies compared PMF with GOF, reporting on 599 patients. No statistically significant differences were found in mortality (RR 0.63, 95% CI: 0.24-1.68, P = 0.36), LOS (standard mean difference -14.52, 95% CI: -42.00 to 12.96, P = 0.30) or treatment failure (RR 1.37, 95% CI: 0.31-6.07, P = 0.68) in patients treated with PMF compared with patients treated with GOF. CONCLUSIONS: Flap-based reconstruction demonstrated improved mortality and treatment outcomes compared to sternal rewiring. However, no significant differences were observed in outcomes between the PMF- and GOF-based reconstructions.

Results of the Phase 1 Open-Label Safety Study of Umbilical Cord Lining Mesenchymal Stromal/Stem Cells (Corlicyte®) to Heal Chronic Diabetic Foot Ulcers.

BACKGROUND: Mesenchymal stromal/stem cells (MSCs) play a critical role in wound healing. Corlicyte® is an MSC product derived from allogeneic umbilical cord tissue donated under an institutional review board-approved protocol and processed in accordance with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. This open-label phase 1 trial was performed under a United States Food and Drug Administration Investigational New Drug Application to establish the safety and tolerability of Corlicyte® in patients with diabetes and chronic diabetic foot ulcer (DFU). METHODS: Escalating doses were applied topically twice a week for up to 8 weeks after ulcer debridement, wound photography, and measurement. Subjects were followed for 4 weeks after the treatment phase. Adverse events were assessed at every visit. RESULTS: Nine subjects in 2 dosing cohorts completed the trial. No subjects experienced a serious adverse reaction to Corlicyte® or the development of anti-human leukocyte antigen (HLA) antibodies. Sixty percentage of subjects in the lower dose cohort experienced ulcer closure by Day 70 of follow-up, while the mean ulcer size was reduced by 54-67% in the other subjects. CONCLUSIONS: Topical administration of Corlicyte®, a novel biologic therapy consisting of allogeneic umbilical cord lining MSCs, appeared safe and tolerable and resulted in a significant decrease in ulcer area, demonstrating its potential as a therapy for healing of chronic DFU.