Outcomes of Dermal Regeneration Templates in Irradiated and Nonirradiated Scalp Defects.

OBJECTIVES: Dermal regeneration templates (DRTs) are frequently used to treat scalp defects. The aim was to compare the time course of healing for DRTs in scalp defects with and without preoperative radiation. METHODS: The authors conducted a retrospective cohort study of DRT-based scalp reconstruction at 2 academic medical centers between 2013 and 2022. Information was collected on demographic variables, comorbidities, medication use, history of radiation, and DRT outcomes. The primary outcome was DRT loss, defined as exposed calvarium or DRT detachment based on postoperative follow-up documentation. Kaplan-Meier survival analysis and multivariable Cox proportional-hazard regressions were used to compare DRT loss in irradiated and nonirradiated defects. Multivariable logistic regressions were used to compare 30-day postoperative complications (infection, hematoma, or seroma) in irradiated and nonirradiated defects. RESULTS: In total, 158 cases were included. Twenty-eight (18%) patients had a preoperative history of radiation to the scalp. The mean follow-up time after DRT placement was 2.6 months (SD: 4.5 mo). The estimated probability of DRT survival at 2 months was 91% (95% CI: 83%-100%) in nonirradiated patients and 65% (95% CI: 48%-88%) in irradiated patients. In the 55 patients with a bony wound base, preoperative head radiation was associated with a higher likelihood of DRT loss (hazard ratio: 11). Half the irradiated defects experienced uncomplicated total wound closure using Integra Wound Matrix Dressing with or without second-stage reconstruction. CONCLUSIONS: Dermal regeneration template can offer durable coverage in nonirradiated scalp defects. Although DRT loss is more likely in irradiated scalp defects, successful DRT-based reconstruction is possible in select cases.

A purified reconstituted bilayer matrix shows improved outcomes in treatment of non-healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi-centre clinical trial.

As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.

The long-term intercorrelation between post-burn pain, anxiety, and depression: a post hoc analysis of the "RE-ENERGIZE" double-blind, randomized, multicenter placebo-controlled trial.

BACKGROUND: Despite the growing prevalence of burn survivors, a gap persists in our understanding of the correlation between acute burn trauma and the long-term impact on psychosocial health. This study set out to investigate the prevalence of long-term pain and symptoms of anxiety and depression in survivors of extensive burns, comparing this to the general population, and identify injury and demographic-related factors predisposing individuals to psychosocial compromise. METHODS: RE-ENERGIZE was an international, double-blinded, randomized-controlled trial that enrolled 1200 patients with partial- or full-thickness burns that required surgical treatment. For the post hoc analysis, we excluded participants who did not complete the Short Form Health Survey (SF-36) questionnaire. Normative data were taken from the 2021 National Health Interview Survey dataset. Propensity score matching was performed using the nearest-neighbor 1-to-1 method, and the two cohorts were compared in terms of chronic pain, and symptoms of anxiety and depression. A multivariable analysis was performed on the burns cohort to identify factors predicting post-discharge pain and symptoms of anxiety and depression. RESULTS: A total of 600 burn patients and 26,666 general population adults were included in this study. Following propensity score matching, both groups comprised 478 participants each, who were predominately male, white, overweight and between 20 and 60 years old. Compared to the general population, burn patients were significantly more likely to report the presence of moderate and a lot of pain (p = 0.002). Symptoms of anxiety were significantly higher in the burn population in two of four levels (most of the time; some of the time; p < 0.0001 for both). Responders in the burn population were significantly less likely to report the absence of depressive symptoms (p < 0.0001). Burn patients were also significantly more likely to report that their mental health affects their social life. TBSA, history of depression, and female sex were identified as independently associated factors for pain, anxiety, and depressive symptoms. The presence of chronic pain and anxiety symptoms independently predicted for symptoms of depression. CONCLUSIONS: Analyzing the largest multicenter cohort of patients with extensive burns, we find that burn injury is associated with chronic pain, and symptoms of anxiety and depression. In addition, TBSA-burned and history of depression directly correlate with the prevalence of chronic pain, and symptoms of anxiety and depression. Finally, pain, and symptoms of anxiety and depression are interrelated and may have interactive effects on the process of recovery following burn injury. Burn patients would, therefore, benefit from a multidisciplinary team approach with early mobilization of pain and mental health experts, in order to promptly prevent the development of psychosocial challenges and their consequences.

The combined risk predictive power of frailty and hypoalbuminemia in free tissue flap reconstruction: A cohort study of 34,571 patients from the NSQIP database.

INTRODUCTION: Significant morbidity and mortality are hallmarks of the functional decline seen in physically frail patients. The modified frailty index 5 (mFI-5) represents a risk predictor score that has been validated as a comorbidity-based scale in surgery. Serum albumin levels of <3.5 g/dL (hypoalbuminemia) have also been implicated with poor postoperative outcomes. However, the association between these two parameters remains to be investigated. We aimed to elucidate the interdependence of preoperative albumin levels and frailty, as evaluated by the mFI-5 score, and its reliability to prognosticate postoperative results in free flap reconstruction (FFR). METHODS: We conducted a multicenter, retrospective cohort study and accessed the ACS National Surgical Quality Improvement Program (ACS-NSQIP) from 2008 to 2021. We identified all adult patients (≥18 years of age) who underwent a FFR. We extracted perioperative data and lab values including albumin. Multivariable linear and logistic regression analyses were performed to identify independent risk predictors. Main outcomes involved mortality, length of hospital stay, reoperation, medical and surgical complications, and discharge destination within the 30-day postoperative period. RESULTS: A total of 34,571 patients were included in the study, with an average age of 53.9 years (standard deviation [SD] 12.2) and an average body mass index (BMI) of 28.8 (SD 6.1). Of these patients, 7484 were male (21.6%), whereas 22,363 (64.7%) had no frailty (mFI = 0). Additionally, 9466 patients had a frailty score of 1 (27.4%), 2505 had a score of 2 (7.2%), 226 had a score of 3 (0.7%), and 11 had a score of 4 or higher (0.0%). Albumin levels were available for 16,250 patients (47.0%), and among them, 1334 (8.2%) had hypoalbuminemia. Regression analyses showed that higher mFI scores were independent predictors of any, surgical, and medical complications, as well as increased rates of reoperations, unplanned readmissions, and prolonged hospital stays. Hypoalbuminemia independently predicted any, surgical, and medical complications, and higher mortality, reoperation, and longer hospital stay. When both frailty and albumin levels (mFI-5 and albumin) were considered together, this combined assessment was found to be a more accurate predictor of all major outcomes (any, medical and surgical complications, mortality, and reoperation). Further, our analysis identified a weak negative correlation between serum albumin levels and mFI scores (Spearman R: -.1; p < .0001). CONCLUSION: In conclusion, this cohort study highlights the association of hypoalbuminemia with adverse postoperative outcomes, including those not directly related to frailty. Simultaneously, higher mFI scores independently predicted outcomes not associated with hypoalbuminemia. Stemming from these findings, we recommend considering both serum albumin levels and frailty in patients receiving FFR. This perioperative algorithm may help provide more individualized planning including multidisciplinary care and pre and posthabilitation.

Dermal Regeneration Template in the Management and Reconstruction of Burn Injuries and Complex Wounds: A Review.

Background: Dermal scaffolds have created a paradigm shift for burn and wound management by providing improved healing and less scarring, while improving cosmesis and functionality. Dermal regeneration template (DRT) is a bilayer membrane for dermal regeneration developed by Yannas and Burke in the 1980s. The aim of this review is to summarize clinical evidence for dermal scaffolds focusing on DRT for the management and reconstruction of burn injuries and complex wounds. Methods: A comprehensive search of PubMed was performed from the start of indexing through November 2022. Articles reporting on DRT use in patients with burns, limb salvage, and wound reconstruction were included with focus on high-level clinical evidence. Results: DRT has become an established alternative option for the treatment of full-thickness and deep partial-thickness burns, with improved outcomes in areas where cosmesis and functionality are important. In the management of diabetic foot ulcers, use of DRT is associated with high rates of complete wound healing with a low risk of adverse outcomes. DRT has been successfully used in traumatic and surgical wounds, showing particular benefit in deep wounds and in the reconstruction of numerous anatomical sites. Conclusions: Considerable clinical experience has accrued with the use of DRT beyond its original application for thermal injury. A growing body of evidence from clinical studies reports the successful use of DRT to improve clinical outcomes and quality of life across clinical indications at a number of anatomical sites.

Phototherapy Restores Deficient Type I IFN Production and Enhances Antitumor Responses in Mycosis Fungoides.

Transcriptional profiling demonstrated markedly reduced type I IFN gene expression in untreated mycosis fungoides (MF) skin lesions compared with that in healthy skin. Type I IFN expression in MF correlated with antigen-presenting cell-associated IRF5 before psoralen plus UVA therapy and epithelial ULBP2 after therapy, suggesting an enhancement of epithelial type I IFN. Immunostains confirmed reduced baseline type I IFN production in MF and increased levels after psoralen plus UVA treatment in responding patients. Effective tumor clearance was associated with increased type I IFN expression, enhanced recruitment of CD8+ T cells into skin lesions, and expression of genes associated with antigen-specific T-cell activation. IFNk, a keratinocyte-derived inducer of type I IFNs, was increased by psoralen plus UVA therapy and expression correlated with upregulation of other type I IFNs. In vitro, deletion of keratinocyte IFNk decreased baseline and UVA-induced expression of type I IFN and IFN response genes. In summary, we find a baseline deficit in type I IFN production in MF that is restored by psoralen plus UVA therapy and correlates with enhanced antitumor responses. This may explain why MF generally develops in sun-protected skin and suggests that drugs that increase epithelial type I IFNs, including topical MEK and EGFR inhibitors, may be effective therapies for MF.

An ACS-NSQIP Data Analysis of 30-Day Outcomes Following Surgery for Bell's Palsy.

BACKGROUND: There exists a paucity of large-scale, multi-institutional studies that investigate the outcomes of surgery for Bell's palsy (BP). Here, we utilize a large, multi-institutional database to study the risk factors and early-stage outcomes following surgical procedures in BP. METHODS: We reviewed the American College of Surgeons National Surgical Quality Improvement Program database (2008-2019) to identify patients who underwent surgery for the diagnosis of BP. We extracted data on comorbidities and preoperative blood values, and 30-day postoperative outcomes. RESULTS: Two hundred fifty-seven patients who underwent surgery for BP symptoms over the 12-year review period were identified. Muscle grafts (n=50; 19%) and fascial grafts (n=48; 19%) accounted for the majority of procedures. The most common comorbidities were hypertension (n=89; 35%) and obesity (n=79; 31%). Complications occurred in 26 (10.1%) cases. Additionally, length of hospital stay was significantly associated with both surgical and medical complications (3.9±4.7 versus 1.5±2.0; P <0.01) and (3.2±3.8 versus 1.4±2.0; P <0.01), respectively. Preoperative creatinine, blood urea nitrogen, and alkaline phosphatase were identified as potential predictors of poor postoperative outcomes. CONCLUSION: Based on multi-institutional analysis, complication rates following surgery for BP were found to be overall low and seen to correlate with length of hospital stay. Reoperations and readmissions were the most frequent complications after surgery for BP. The preoperative evaluation of routine laboratory values may help refine patient eligibility and risk stratification. In addition, our findings call for future large-scale prospective studies in the field of facial palsy surgery to further improve the quality of care and optimize perioperative protocols.

Racial disparities in surgical outcomes after mastectomy in 223 000 female breast cancer patients: a retrospective cohort study.

BACKGROUND: Breast cancer mortality and treatment differ across racial groups. It remains unclear whether such disparities are also reflected in perioperative outcomes of breast cancer patients undergoing mastectomy. STUDY DESIGN: The authors reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2008-2021) to identify female patients who underwent mastectomy for oncological purposes. The outcomes were stratified by five racial groups (white, Black/African American, Asian, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander) and included 30-day mortality, reoperation, readmission, surgical and medical complications, and non-home discharge. RESULTS: The study population included 222 947 patients, 68% ( n =151 522) of whom were white, 11% ( n =23 987) Black/African American, 5% ( n =11 217) Asian, 0.5% ( n =1198) American Indian/Alaska Native, and 0.5% ( n =1018) Native Hawaiian/Pacific Islander. While 136 690 (61%) patients underwent partial mastectomy, 54 490 (24%) and 31 767 (14%) women received simple and radical mastectomy, respectively. Overall, adverse events occurred in 17 222 (7.7%) patients, the largest portion of which were surgical complications ( n =7246; 3.3%). Multivariable analysis revealed that being of Asian race was protective against perioperative complications [odds ratio (OR)=0.71; P <0.001], whereas American Indian/Alaska Native women were most vulnerable to the complication occurrence (OR=1.41; P <0.001). Black/African American patients had a significantly lower risk of medical (OR=0.59; P <0.001) and surgical complications (OR=0.60; P <0.001) after partial and radical mastectomy, respectively, their likelihood of readmission (OR=1.14; P =0.045) following partial mastectomy was significantly increased. CONCLUSION: The authors identified American Indian/Alaska Native women as particularly vulnerable to complications following mastectomy. Asian patients experienced the lowest rate of complications in the perioperative period. The authors' analyses revealed comparable confounder-adjusted outcomes following partial and complete mastectomy between Black and white races. Their findings call for care equalization in the field of breast cancer surgery.

The significance of timing in breast reconstruction after mastectomy: An ACS-NSQIP analysis.

BACKGROUND: A variety of breast reconstruction (BR) options are available. The significance of timing on outcomes remains debated. This study aims to compare complications in breast cancer patients undergoing implant-based and autologous BR immediately after mastectomy or at a delayed time point. METHODS: We reviewed the ACS-NSQIP database (2008-2021) to identify all female patients who underwent BR for oncological purposes. Outcomes were stratified by technique (implant-based versus autologous) and timing (immediate versus delayed), and included 30-day mortality, reoperation, (unplanned) readmission, and surgical and medical complications. RESULTS: A total of 21,560 patients were included: 11,237 (52%) implant-based (9791/87% immediate, 1446/13% delayed) and 10,323 (48%) autologous (8378/81% immediate, 1945/19% delayed). Complications occurred in 3666 (17%) patients (implant-based: n = 1112/11% immediate, n = 64/4.4% delayed cohorts; Autologous: n = 2073/25% immediate, n = 417/21% delayed cohorts). In propensity score weighting (PSW) analyses, immediate BR was associated with significantly more complications than delayed BR (p < 0.0001). This was the case for both implant-based and autologous BR, with a greater difference between the two time points noted in implant-based. Confounder-adjusted multivariable analyses confirmed these results. CONCLUSION: At the 30-day time point, delayed BR is associated with significantly lower complication rates than immediate BR, in both the implant-based and autologous cohorts. These findings are not a blanket recommendation in favor of immediate and/or delayed BR. Instead, our insights may guide surgeons and patients in decision-making and help refine patients' eligibility in a case-by-case workup.

PPARγ agonist treatment reduces fibroadipose tissue in secondary lymphedema by exhausting fibroadipogenic PDGFRα+ mesenchymal cells.

Secondary lymphedema occurs in up to 20% of patients after lymphadenectomy performed for the surgical management of tumors involving the breast, prostate, uterus, and skin. Patients develop progressive edema of the affected extremity due to retention of protein-rich lymphatic fluid. Despite compression therapy, patients progress to chronic lymphedema in which noncompressible fibrosis and adipose tissue are deposited within the extremity. The presence of fibrosis led to our hypothesis that rosiglitazone, a PPARγ agonist that inhibits fibrosis, would reduce fibrosis in a mouse model of secondary lymphedema after hind limb lymphadenectomy. In vivo, rosiglitazone reduced fibrosis in the hind limb after lymphadenectomy. Our findings verified that rosiglitazone reestablished the adipogenic features of TGF-ß1-treated mesenchymal cells in vitro. Despite this, rosiglitazone led to a reduction in adipose tissue deposition. Single-cell RNA-Seq data obtained from human tissues and flow cytometric and histological evaluation of mouse tissues demonstrated increased presence of PDGFRα+ cells in lymphedema; human tissue analysis verified these cells have the capacity for adipogenic and fibrogenic differentiation. Upon treatment with rosiglitazone, we noted a reduction in the overall quantity of PDGFRα+ cells and LipidTOX+ cells. Our findings provide a framework for treating secondary lymphedema as a condition of fibrosis and adipose tissue deposition, both of which, paradoxically, can be prevented with a pro-adipogenic agent.

Regulatory T cells in skin regeneration and wound healing.

As the body's integumentary system, the skin is vulnerable to injuries. The subsequent wound healing processes aim to restore dermal and epidermal integrity and functionality. To this end, multiple tissue-resident cells and recruited immune cells cooperate to efficiently repair the injured tissue. Such temporally- and spatially-coordinated interplay necessitates tight regulation to prevent collateral damage such as overshooting immune responses and excessive inflammation. In this context, regulatory T cells (Tregs) hold a key role in balancing immune homeostasis and mediating cutaneous wound healing. A comprehensive understanding of Tregs' multifaceted field of activity may help decipher wound pathologies and, ultimately, establish new treatment modalities. Herein, we review the role of Tregs in orchestrating the regeneration of skin adnexa and catalyzing healthy wound repair. Further, we discuss how Tregs operate during fibrosis, keloidosis, and scarring.

The surgical patient of yesterday, today, and tomorrow-a time-trend analysis based on a cohort of 8.7 million surgical patients.

BACKGROUND: Global healthcare delivery is challenged by the aging population and the increase in obesity and type 2 diabetes. The extent to which such trends affect the cohort of patients the authors surgically operate on remains to be elucidated. Comprising of 8.7 million surgical patients, the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database can be analyzed to investigate the echo of general population dynamics and forecast future trends. MATERIAL AND METHODS: The authors reviewed the ACS-NSQIP database (2008-2020) in its entirety, extracting patient age, BMI, and diabetes prevalence. Based on these data, the authors forecasted future trends up to 2030 using a drift model. RESULTS: During the review period, median age increased by 3 years, and median BMI by 0.9 kg/m2. The proportion of patients with overweight, obesity class I, and class II rates increased. The prevalence of diabetes rose between 2008 (14.9%) and 2020 (15.3%). The authors forecast the median age in 2030 to reach 61.5 years and median BMI to climb to 29.8 kg/m2. Concerningly, in 2030, eight of ten surgical patients are projected to have a BMI above normal. Diabetes prevalence is projected to rise to 15.6% over the next decade. CONCLUSION: General population trends echo in the field of surgery, with the surgical cohort aging at an alarmingly rapid rate and increasingly suffering from obesity and diabetes. These trends show no sign of abating without dedicated efforts and call for urgent measures and fundamental re-structuring for improved future surgical care.

A Prospective Multicenter Study of a Weekly Application Regimen of Viable Human Amnion Membrane Allograft in the Management of Nonhealing Diabetic Foot Ulcers.

Background: Diabetic foot ulcers (DFUs) pose a significant clinical challenge for providers and patients, and often precede devastating complications such as infection, hospitalization, and amputation. Therefore, advanced treatment options are needed to facilitate the healing of chronic DFUs and improve outcomes in this high-risk population. Cryopreserved viable human amnion membrane allograft (vHAMA) has shown great promise in the treatment of recalcitrant DFUs as a supplement to standard of care (SOC). Placental grafts are rich in extracellular matrix proteins, growth factors, and cytokines, which can induce angiogenesis and dermal fibroblast proliferation, resulting in accelerated healing. Methods: In this prospective, multicenter single arm trial, 20 patients with nonhealing DFUs received weekly application of vHAMA, in addition to SOC, for up to 12 weeks. The primary study endpoint was proportion of healed wounds at 12 weeks. Secondary endpoints included proportion of wounds healed at 6 weeks, time to heal, and percentage area wound reduction. Subjects were evaluated for ulcer healing and assessed for adverse events at every treatment visit. Results: At study conclusion, 85% of patients receiving vHAMA healed. Ten wounds healed (50%) by 6 weeks, and 17 wounds (85%) healed by 12 weeks. The mean time to heal was 46.6 days (95% CI: 35.1-58.0), and the average number of vHAMAs used was 5.4 (SD: 3.25). The mean PAR was 86.3% (SD: 40.51). Conclusions: Aseptically processed, cryopreserved vHAMA should be considered as a safe and effective option for DFUs refractory to SOC therapy.

Impact of sarcopenia on outcomes in surgical patients: a systematic review and meta-analysis.

BACKGROUND: Surgeons have historically used age as a preoperative predictor of postoperative outcomes. Sarcopenia, the loss of skeletal muscle mass due to disease or biological age, has been proposed as a more accurate risk predictor. The prognostic value of sarcopenia assessment in surgical patients remains poorly understood. Therefore, the authors aimed to synthesize the available literature and investigate the impact of sarcopenia on perioperative and postoperative outcomes across all surgical specialties. METHODS: The authors systematically assessed the prognostic value of sarcopenia on postoperative outcomes by conducting a systematic review and meta-analysis according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, searching the PubMed/MEDLINE and EMBASE databases from inception to 1st October 2022. Their primary outcomes were complication occurrence, mortality, length of operation and hospital stay, discharge to home, and postdischarge survival rate at 1, 3, and 5 years. Subgroup analysis was performed by stratifying complications according to the Clavien-Dindo classification system. Sensitivity analysis was performed by focusing on studies with an oncological, cardiovascular, emergency, or transplant surgery population and on those of higher quality or prospective study design. RESULTS: A total of 294 studies comprising 97 643 patients, of which 33 070 had sarcopenia, were included in our analysis. Sarcopenia was associated with significantly poorer postoperative outcomes, including greater mortality, complication occurrence, length of hospital stay, and lower rates of discharge to home (all P <0.00001). A significantly lower survival rate in patients with sarcopenia was noted at 1, 3, and 5 years (all P <0.00001) after surgery. Subgroup analysis confirmed higher rates of complications and mortality in oncological (both P <0.00001), cardiovascular (both P <0.00001), and emergency ( P =0.03 and P =0.04, respectively) patients with sarcopenia. In the transplant surgery cohort, mortality was significantly higher in patients with sarcopenia ( P <0.00001). Among all patients undergoing surgery for inflammatory bowel disease, the frequency of complications was significantly increased among sarcopenic patients ( P =0.007). Sensitivity analysis based on higher quality studies and prospective studies showed that sarcopenia remained a significant predictor of mortality and complication occurrence (all P <0.00001). CONCLUSION: Sarcopenia is a significant predictor of poorer outcomes in surgical patients. Preoperative assessment of sarcopenia can help surgeons identify patients at risk, critically balance eligibility, and refine perioperative management. Large-scale studies are required to further validate the importance of sarcopenia as a prognostic indicator of perioperative risk, especially in surgical subspecialties.

Free Tissue Transfer in Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis.

OBJECTIVE: Free tissue transfer is a powerful reconstructive method for patients with substantial diabetic foot ulcers. This study aimed to perform an updated systematic review and meta-analysis investigating the flap characteristics, concurrent revascularisation rates, complications, and outcomes associated with free tissue transfer in diabetic foot ulcers. METHODS: Two reviewers performed a systematic review of various databases since their inception, with no language restriction. Only data for free tissue transfer in non-traumatic diabetic foot ulcer patients were extracted from included studies where a heterogeneous population was studied. Outcome data were pooled using random effects meta-analysis for binomial data. RESULTS: Of 632 studies identified, 67 studies encompassing 1 846 patients and 1 871 free flaps were included. A median of 18 patients [IQR 9, 37] per study, with a median age of 58.5 years [56, 63], were followed up for a median of 15 months [7, 25]. Most studies had serious risk of bias (n = 47 studies, 70%); sixteen (24%) had moderate risk of bias; and four (6%) had low risk of bias. The proportion of patients who underwent revascularisation was 75% (95% CI 60 - 87%; n = 36 studies) with a median time of 8 days between procedures. The pooled complete flap survival, major amputation, and ambulation rates were 88% (85 - 92%, n = 49 studies), 10% (7 - 14%, n = 50 studies), and 87% (80 - 92%, n = 36 studies), respectively. Death at individual study follow up was 6% (3 - 10%, n = 26 studies). The overall certainty of evidence was very low. CONCLUSION: Free tissue transfer may be a useful treatment modality for recalcitrant diabetic foot ulcers in selected patients. Future studies should investigate long term functional outcomes and aim to develop patient selection algorithms to select the most suitable candidates for this procedure.

A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis.

A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.

Incidence and Risk Factors of Postoperative Complications After Rhinoplasty: A Multi-Institutional ACS-NSQIP Analysis.

OBJECTIVE: Despite the popularity of rhinoplasty, outcome research has been mainly limited to single-surgeon or single-institution reports. Therefore, we performed a multi-institutional analysis to present a broader portrait of the postoperative outcomes and risk factors for adverse events after rhinoplasty surgery. METHODS: We reviewed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2009-2019) to identify patients who underwent rhinoplasty. The postoperative outcomes of interest included 30-day mortality, reoperation, readmission, and surgical and medical complications. We also analyzed risk factors for complication occurrence, including patient comorbidities and preoperative laboratory values. RESULTS: We identified 835 patients, 72% (n=602) of whom underwent a primary, 21% (n=175) a secondary, and 6.7% (n=58) a cleft nasal deformity procedure. The average patient age was 41±17 years, with most patients being female (n=472; 57%) and white (n=643; 77%). Complications rates were generally low, with reoperation (n=19; 2.3%) and superficial incisional infection (n=9; 1.1%) account for the most common general and surgical adverse event, respectively. Multivariable analysis revealed male sex ( P =0.04) and higher ASA scores ( P <0.0001) as risk factors for complications. Low serum albumin ( P =0.04) and hematocrit ( P =0.003) levels were associated with the occurrence of any complication, whereas low serum albumin ( P =0.02) also correlated with the incidence of surgical adverse events. CONCLUSION: Complication rates after rhinoplasty were overall low and seemed to correlate with male sex and ASA scores. We identified preoperative albumin and hematocrit as predictive biomarkers of adverse events. Preoperative nutritional optimization and management of low hematocrit may improve postoperative outcomes.

Advances in Translational Regenerative Therapies.

Regenerative medicine aims to replace damaged cells and tissues following injury [...].