Psychiatric Influences on Hidradenitis Suppurativa: A Call for Help.

Background Hidradenitis suppurativa (HS) is associated with a high prevalence of psychiatric disorders. However, no studies examine how psychiatric disorders influence surgical and financial outcomes. This study aimed to assess impact of a psychiatric diagnosis on patients treated for HS. Methods Patients with HS were retrospectively identified at a single institution from 2010 to 2021. Cohorts were stratified by the presence of a psychiatric disorder. Demographics, comorbidities, and disease characteristics were collected. Outcomes assessed included the procedural interventions and emergency department (ED) visits. Financial distress was assessed via the COST-FACIT Version 2 survey. Results Out of 138 patients, 40 (29.0%) completed the survey of which 19 (47.5%) had a preexisting psychiatric diagnosis. No demographic differences were found between cohorts. Mean follow-up was 16.1 ± 11.0 months. The psychiatric cohort had a higher median number of surgeries received (7.0 vs. 1.5, p < 0.001), a higher median number of ED visits (1.0 vs. 0, p = 0.006), and a similar hospital length of stay ( p = 0.456). The mean COST-FACIT score of the overall study population was 19.2 ± 10.7 (grade 1 financial toxicity). The psych cohort had a lower mean COST-FACIT score (16.8 vs. 21.3, p = 0.092) and reported greater financial hardship (3.3 vs. 1.7, p < 0.001). On multivariate analysis, a psychiatric diagnosis was predictive of lower credit scores, more ED visits, and a higher number of surgeries. Conclusion Preexisting psychiatric conditions in patients with HS are associated with increased health care utilization and surgical intervention with substantial financial distress. Plastic surgeons should be cognizant of such comorbid disorders to facilitate holistic care addressing all patient needs.

"Comparison of Outcomes After Autologous Breast Reconstruction: Latissimus Dorsi with Immediate Fat Transfer vs. Abdominally Based Free Flaps".

BACKGROUND: Autologous breast reconstruction confers favorable patient reports of satisfaction and quality of life compared to implant-based reconstruction over a lifetime. The latissimus dorsi with immediate fat transfer (LIFT) is an alternative approach to abdominally based free flaps (Ab-FF), which expands fully autologous reconstruction to non-microsurgeons. This study aims to compare the two procedures concerning their clinical and patient-reported outcomes one year postoperatively. METHODS: We conducted a retrospective review of LIFTs and Ab-FFs performed between March 2017 and August 2022. The primary outcomes were postoperative complications, reoperations, and longitudinal BREAST-Q scores. BREAST-Q modules included Satisfaction with Breasts, Abdomen, Back, Psychosocial Well-being, Physical Well-being: Chest, Abdomen, Back, and Sexual Well-being. RESULTS: Of the 281 included patients (408 breasts), 211 received Ab-FF, and 70 received LIFT. One-year follow-up (median [IQR]: 12 [12] months) demonstrated that Ab-FF independently predicted dehiscence, reoperation procedures, and revisional surgery. LIFT independently increased the odds of seroma. In addition, obesity predicted dehiscence, while bilateral reconstructions predicted revisional fat grafting. BREAST-Q scores fluctuated over time but were similar across all measured domains by one year postoperatively. CONCLUSIONS: Although Ab-FF is the gold-standard approach for fully autologous reconstruction, LIFT procedures may be associated with a less complicated postoperative course while eliciting similar patient-reported outcomes. LIFT may subsequently be preferred to limit postoperative complications, particularly in patients with obesity. LIFT can also be utilized by more plastic surgeons who are either not microsurgically trained or do not have an environment that fosters Ab-FF.

The Effect of Obesity on Vaginoplasty Outcomes.

BACKGROUND: Some surgeons use body mass index criteria within the patient selection processes before vaginoplasty, thereby limiting access to select obese patients. We sought to better characterize the effect of obesity on postoperative outcomes across multiple vaginoplasty techniques. METHODS: A single-center retrospective review of all transfeminine patients undergoing primary vaginoplasty procedures from December 2018 to July 2022 was conducted. Patients were stratified into cohorts according to the World Health Organization Obesity Class criteria. Data regarding demographics, comorbidities, operative details, postoperative complications, and all-cause revision were collected. RESULTS: A total of 237 patients met the inclusion criteria. Average follow-up duration was 9.1 ± 4.7 months. Multivariate regression revealed that patients with class I and class II/III obesity were associated with higher odds of developing vaginal stenosis (class I: odds ratio [OR], 7.1 [ P = 0.003]; class II/III: OR, 3.4 [ P = 0.018]) and all-cause revision (class I: OR, 3.7 [ P = 0.021]; class II/III: OR, 4.8 [ P = 0.027]). Undergoing either robotic peritoneal or robotic intestinal vaginoplasty was associated with lower odds of delayed wound healing (peritoneal: OR, 0.2 [ P < 0.001]; intestinal: OR, 0.2 [ P = 0.011]). Lastly, adherence to dilation regimen was negatively associated with development of vaginal stenosis (OR, 0.04; P < 0.001). CONCLUSIONS: Patients with obesity may be at a higher risk of developing vaginal stenosis after vaginoplasty, which may ultimately necessitate operative revision. Although patients with obesity may remain surgical candidates, proper preoperative counseling and adherence to postoperative vaginal dilation regimens are critical to optimizing outcomes.

A case of necrotizing fasciitis of the breast following lumpectomy and oncoplastic closure.

BACKGROUND: NF is a life-threatening soft tissue infection that most commonly occurs in the lower extremity. While presenting symptoms such as erythema, severe pain, sepsis, and wound crepitation are well documented, diagnosis of NF of the breast often is obscured by a low clinical index of suspicion due to its relative rarity as well as by the breast parenchyma that physically separates the underlying fascia and overlying skin. Several risk factors have previously been identified, such as underlying infection, diabetes, advanced age, and immunosuppression. However, the gross morbidity and high mortality associated with NF warrant continued surveillance of contributing factors across any anatomic location. Fifteen cases in the literature document the development of NF following breast surgery. CASE REPORT: The authors of this case report aim to expand on the current literature through the presentation of a unique case of NF of the breast following right breast lumpectomy and oncoplastic closure with left reduction mammaplasty in an immunocompromised patient found to have concurrent perforated sigmoid diverticulitis. CONCLUSION: This case exemplifies how frequent postoperative surveillance, a low threshold for intervention, and efficient coordination of care are vital to minimizing the morbidity and mortality risks associated with NF of the breast.

Age is just a number: The role of advanced age in predicting complications following ventral hernia repair with component separation.

BACKGROUND: While advanced age is often considered a risk factor for complications following abdominal surgery, its impact on outcomes after complex open ventral hernia repair (VHR) with component separation technique (CST) remains unclear. METHODS: A single-center retrospective review of patients who VHR with CST from November 2008 to January 2022 was performed and cohorts were stratified by presence of advanced age (≥60 years). RESULTS: Of 219 patients who underwent VHR with CST, 114 patients (52.1 â€‹%) were aged ≥60 years. Multivariate analysis demonstrated BMI to be an independent predictor for any complication (OR 1.1, p â€‹= â€‹0.002) and COPD was positively associated with seroma development (OR 20.1, p â€‹= â€‹0.012). Advanced age did not independently predict postoperative outcomes, including hernia recurrence (OR 0.8, p â€‹= â€‹0.766). CONCLUSIONS: VHR with CST is generally safe to perform in patients of advanced age. Every patient's comorbidity profile should be thoroughly assessed preoperatively for risk stratification regardless of age.

Free Tissue Transfer to the Lower Extremity in the Setting of Thrombocytosis and the Role of Antiplatelet Therapy: A Propensity Score-Matched Analysis.

BACKGROUND: Free tissue transfer (FTT) provides a versatile method to achieve successful lower limb salvage. Thrombocytosis in patients undergoing lower extremity (LE) FTT is associated with increased risk of complications. The aims of this study were to assess the feasibility of performing LE FTT in patients with preoperative thrombocytosis, and whether antiplatelet (AP) therapy on the day of surgery (DOS) affects outcomes. METHODS: A retrospective review of thrombocytotic patients who underwent LE FTT between 2011 and 2022 was performed. Patients were stratified into groups based on the receipt of AP therapy on the DOS. Patients were propensity score matched for comorbidity burden and postoperative risk stratification. Outcomes of interest included perioperative transfusion requirements, postoperative flap-related complications, rates of flap success, limb salvage, and ambulatory status. RESULTS: Of the 279 patients who underwent LE FTT, 65 (23.3%) were found to have preoperative thrombocytosis. Fifty-three patients remained following propensity score matching; of which, 32 (60.4%) received AP therapy on the DOS and 21 (39.6%) did not. Overall flap success rate was 96.2% (n = 51). The likelihoods of thrombosis and hematoma development were similar between cohorts (p = 0.949 and 0.574, respectively). Receipt of DOS AP therapy was associated an additional 2.77 units and 990.10 mL of transfused blood (p = 0.020 and 0.018, respectively). At a mean follow-up of 20.7 months, overall limb salvage and ambulatory rates were 81.1% (n = 43) and 79.2% (n = 42), respectively, with no differences between cohorts. CONCLUSION: Preoperative thrombocytosis is not an absolute contraindication to LE FTT. DOS AP therapy may be protective in comorbid patients with elevated platelet counts but must be weighed against possible short-term bleeding as suggested by significant increases in postoperative transfusion requirements.

Postoperative Glycemic Response in High-Risk Type II Diabetics Receiving Below-Knee Amputation: Does Intraoperative Dexamethasone Make an Impact?

Despite known risks of hyperglycemia on postoperative complications, the influence of intraoperative dexamethasone on blood glucose has yet to be evaluated within the diabetic limb salvage population. This study aimed to assess the effect of intraoperative dexamethasone on postoperative blood glucose in diabetic patients undergoing atraumatic major lower extremity amputations. A single-center retrospective review of diabetic patients undergoing below-knee amputation between January 2017 and December 2022 was performed. Blood glucose levels for the 5 days before and after amputation were recorded and compared with the primary endpoints of postoperative hyperglycemia (>200 mg/dL) and glucose variability (>200 mg/dL). Cohorts were divided by patients who did and did not receive intraoperative administration of dexamethasone. Three hundred eighty-one were screened for eligibility with 180 patients included. Of these, 50 patients received dexamethasone intraoperatively (38.5%). Average pre- and postoperative blood glucose, rate of pre- and postoperative hyperglycemia, perioperative glucose variability, and postoperative dehiscence and infection were comparable between cohorts. On multivariate analysis, intraoperative administration of dexamethasone was not associated with postoperative hyperglycemia (p = .104) or perioperative blood glucose variability > 200 mg/dL (p = .334). Perioperative blood glucose variability > 200 mg/dL was associated with higher odds of surgical site infection (SSI) (odds ratio 5.12, p = .003). Administration of intravenous dexamethasone to diabetic patients undergoing below-knee amputation is not associated with postoperative hyperglycemia or complications. This study confirms previous findings that high glucose is a predictor of SSI. Concerted effort by a multidisciplinary team to attain tight glycemic control is critical to optimizing healing.

Parents' Perceptions of Social Media Use by Pediatric Plastic Surgeons.

BACKGROUND: Pediatric craniofacial surgeons face specific ethical and professional concerns regarding the growth of social media use in plastic surgery. The authors sought to elucidate parents' views on social media use by pediatric craniofacial surgeons. In addition, the study examines issues of consent, assent, and exploitation. METHODS: An anonymous, 51-question, multiple-choice survey investigating parents' views of pediatric plastic surgeons' social media use was crowdsourced through Prolific.Co. RESULTS: A total of 681 parents responded to the survey. Of the 656 included respondents, 88% to 93% believe that surgeons need to obtain consent from the parents to post pictures of the pediatric patient on social media, regardless of age. Respectively, 84.5% and 75% of respondents believe the surgeon needs to document assent from the 12- and 10-year-old patient. Parents who follow plastic surgeons on social media are more likely to agree that assent needs to be documented from all pediatric patients, regardless of age, before posting pictures on social media. The mean age at which respondents believe physicians should be required to elicit assent from the pediatric patient to post pictures was 9.65 years. Approximately 40% of respondents felt that patients portrayed in pictures on social media were being exploited, irrespective of the child's stated age. CONCLUSIONS: Plastic surgeons need to recognize parents' perceptions regarding social media use when considering posting pictures of pediatric patients on social media. The data suggest that surgeons should elicit assent from patients as young as 9 years before posting pictures on social media.

Lymphovenous Coupler-Assisted Bypass for Immediate Lymphatic Reconstruction.

BACKGROUND: Breast cancer-related lymphedema is the most common cause of lymphedema in the United States and occurs in up to 50% of individuals receiving axillary lymph node dissection (ALND). Lymphovenous bypass (LVB) at the time of ALND may prevent lymphedema, but long-term results and anastomotic patency are unclear. This study evaluates the feasibility and outcomes of performing immediate lymphatic reconstruction via coupler-assisted bypass (CAB). METHODS: This is a retrospective review of all patients undergoing prophylactic LVB following ALND at two tertiary care centers between 2018 and 2022. Patients were divided into cohorts based on whether they received the "standard" end-to-end (E-E) suturing or CAB technique. The primary outcome of interest was development of lymphedema. Quantitative and qualitative assessments for lymphedema were performed preoperatively and at 3, 6, 12, and 24 months postoperatively. RESULTS: Overall, 63 LVBs were performed, of which 24 lymphatics underwent immediate reconstruction via "CAB" and 39 lymphatics via "standard" end-to-end suture. Patient characteristics, including body mass index, and treatment characteristics, including radiation therapy, did not significantly differ between groups. CAB was associated with a greater mean number of lymphatics bypassed per vein (standard 1.7 vs. CAB 2.6, p = 0.0001) and bypass to larger veins (standard 1.2 vs. CAB 2.2 mm, p < 0.0001). At a median follow-up of 14.7 months, 9.1% (1/11) of individuals receiving CAB developed lymphedema. These rates were similar to those seen following standard bypass at 4.8% (1/21), although within a significantly shorter follow-up duration (standard 7.8 vs. CAB 14.7 months, p = 0.0170). CONCLUSION: The CAB technique is a viable, effective technical alternative to the standard LVB technique. This comparative study of techniques in prophylactic LVB suggests that CABs maintain long-term patency, possibly due to the ease of anastomosing several lymphatics to single large caliber veins while reducing the technical demands of the procedure.

Muscle versus Fascia Free Tissue Transfer for Treatment of Chronic Osteomyelitis in the Comorbid Population.

BACKGROUND: In patients with chronic lower extremity (LE) wounds, chronic osteomyelitis confers additional complexity to achieving adequate treatment. Previous reviews demonstrate increased rates of osteomyelitis recurrence in patients who receive muscle flaps compared with fasciocutaneous flaps for LE limb salvage; however, these studies were not limited to atraumatic populations who receive exclusively free flaps. Thus, this study compared rates of recurrence in chronic osteomyelitis patients undergoing LE reconstruction with fasciocutaneous versus muscle free flaps. METHODS: Patients undergoing free tissue transfer (FTT) between July 2011 and July 2021 were retrospectively reviewed. Patients were stratified into fasciocutaneous and muscle free flap groups. Primary outcomes included osteomyelitis recurrence, flap complications, limb salvage, and ambulatory status. RESULTS: Forty-eight patients with pathologic diagnosis of chronic osteomyelitis of the wound bed were identified, of which 58.3% received fasciocutaneous (n = 28) and 41.7% received muscle flaps (n = 20). The most common comorbidities included diabetes mellitus (n = 29, 60.4%), peripheral neuropathy (n = 27, 56.3%) and peripheral vascular disease (n = 24, 50.0%). Methicillin-resistant or methicillin -sensitive Staphylococcus aureus were the most common pathogen in 18.7% (n = 9) of procedures. The majority of patients underwent a median of three debridements followed by negative pressure wound therapy prior to receiving FTT. At a median follow-up of 16.6 months, the limb salvage and ambulatory rates were 79.2 (n = 38) and 83.3% (n = 40), respectively. The overall rate of microsurgical flap success was 93.8% (n = 45). Osteomyelitis recurred in 25% of patients (n = 12) at a median duration of 4.0 months. There were no significant differences in rates of osteomyelitis recurrence, flap complications, limb salvage, ambulation, and mortality. On multivariate analysis, flap composition remained a nonsignificant predictor of osteomyelitis recurrence (odds ratio: 0.975, p = 0.973). CONCLUSION: This study demonstrates that flap composition may not influence recurrence of osteomyelitis following free flap reconstruction of chronic LE wounds, suggesting that optimal flap selection should be based on wound characteristics and patient goals.

Small Intestinal Perforation after 360-Degree Liposuction: A Case Report.

OBJECTIVE: As one of the most commonly performed cosmetic procedures, liposuction is relatively safe. Bowel injury following liposuction is a rare but devastating complication, which necessitates hospital admission and surgical intervention. The authors highlight a case report describing the presentation, diagnosis, and management of a patient with bowel injury following liposuction. CASE: A 58-year-old woman presented with abdominal pain, erythema, and discharge three days after 360-degree abdominal liposuction with concomitant fat grafting to bilateral buttocks at an outpatient surgery center. Bowel perforation was suspected after CT-scan revealed extraluminal gas in the abdomen and communication that traversed the peritoneum. Exploratory laparotomy was performed which demonstrated at least one site of distinct perforation of the small bowel and an area omentum noted to be inflamed, thickened and with a purulent rind. The patient underwent 20-cm small bowel resection and partial omentectomy temporarily closed with negative pressure wound therapy. After subsequent abdominal wall debridements the patient received ventral hernia repair with bridging mesh and abdominal closure. CONCLUSIONS: While safe, elective cosmetic procedures are not without risk of serious and even fatal complications. Providers must be familiar with the presentation of bowel injury following abdominal liposuction to prevent delays in appropriate surgical and medical care. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Surgical management of pain or infection secondary to calciphylaxis: a wound center's experience and algorithmic multidisciplinary approach.

BACKGROUND: The role of surgical management of calciphylaxis remains understudied. OBJECTIVE: This article reports a case series and algorithmic approach to the multidisciplinary management of calciphylaxis. METHODS: A single-center retrospective review of all adult patients with calciphylaxis treated surgically between January 2010 and November 2022 was performed. RESULTS: Eleven patients met inclusion criteria. The average age was 50.9 years ± 15.8 SD, and most patients were female (n = 7 [63.6%]). Surgery was indicated for infection (n = 6 [54.5%]) and/or intractable pain (n = 11 [100%]). Patients underwent an average of 2.9 excisional debridements during their hospital course. Following the final excision, wounds were left open in 5 cases (29.4%), closed primarily in 4 (23.5%), and local flaps were used in 3 (27.3%). Postoperatively, the mean time to healing was 57.4 days ± 12.6. Complications included dehiscence (n = 1 [9.1%]), progression to cellulitis (n = 2 [18.2%]), osteomyelitis (n = 1 [9.1%]), and lower extremity amputation (n = 2 [18.2%]). Of the 6 patients alive at the time of healing, 5 (83.3%) were no longer taking narcotic medications. At an average follow-up of 26.4 months ± 34.1, 7 patients (63.6%) were deceased, with an average time to mortality of 4.8 months ± 6.7. Of the 4 remaining patients, 3 (75.0%) were ambulatory by their most recent follow-up visit. CONCLUSION: While the morbidity and mortality associated with calciphylaxis are substantial, surgical excision is effective in reducing pain and improving quality of life in patients with this end-stage disease. Wound care centers are uniquely equipped with a variety of medical and surgical specialists with experience in treating chronic wounds and thus facilitate an efficient multidisciplinary model.

Retrospective review of complications and outcomes in COVID-19-positive patients with comorbidities undergoing limb salvage procedures in a tertiary care wound center.

INTRODUCTION: COVID-19 illness is associated with increased operative risks, ranging from delayed wound healing and coagulopathy to increased risk of mortality. OBJECTIVE: This article describes the authors' recent experience of the implications of COVID-19 on limb salvage procedures. MATERIALS AND METHODS: Patients who underwent LE limb salvage procedures within 30 days of a positive COVID-19 diagnosis were retrospectively reviewed. Patient demographics, comorbidities, surgical factors, postoperative complications, and management were collected. RESULTS: Of 597 patients screened from February 2020 to March 2022, a total of 67 (11.2%) were diagnosed with COVID-19, of which 17 received the diagnosis within 30 days of surgery and were thus included. Average follow-up was 43 ± 3.2 months, at which point 6 (35.3%) were fully healed. The mortality rate at the most recent follow-up visit was 29.4% of patients (n = 5). Two patients required admission to the SICU following index procedure, and 1 necessitated a return to the operating room. CONCLUSION: COVID-19 may negatively affect the wound healing process while increasing the mortality rate amongst patients with multiple or severe comorbidities undergoing limb salvage procedures. Medical providers need to be aware of the complexity of these patients and apply a multi-disciplinary protocol to obtain successful outcomes.

A Comparative Analysis of Functional and Patient-Reported Outcomes Following Lisfranc and Chopart Amputations in High-Risk Limb Salvage Patients.

Midfoot amputations provide an opportunity for limb salvage through preservation of a weightbearing limb. However, the longevity of midfoot amputations is threatened by restrictions in surface area and risks of skin breakdown. To better inform decisions surrounding the level of amputation, we sought to compare outcomes of high-risk individuals who underwent Lisfranc or Chopart amputations. A single-center retrospective cohort study was performed from November 2013 to September 2022 of adult patients who underwent Lisfranc or Chopart amputations. Patients were stratified into cohorts based on the amputation type. Outcomes included postoperative rates of re-amputation, functional status, mortality and patient-reported outcome measures in the form of Lower Extremity Functional Scale scores. Sixty-six patients were identified; of which, 45 underwent Lisfranc amputation, and 21 underwent Chopart amputation. Median Charlson Comorbidity Index was 7, signifying a substantial comorbidity burden. By median follow-up of 14 (Interquartile range: 28) months, 31 patients (36%) progressed to higher-level amputation, and most patients were ambulatory (n = 38, 58%). Overall rates of re-amputation, ambulatory status, and mortality were comparable between groups. Re-amputation to another midfoot amputation was more common among the Lisfranc cohort (n = 16, 36% vs n = 1, 5%), whereas re-amputation to BKA was more prevalent among the Chopart cohort (Chopart: n = 7, 33% vs Lisfranc: n = 7, 16%; p = .011). Average Lower Extremity Functional Scale scores were similar between groups and corresponded to a maximal function of 48%. Lisfranc and Chopart amputations have the potential to be efficacious limb salvage options in high-risk patient populations in conjunction with intraoperative biomechanical optimization and optimal preoperative patient selection.

Examining the unmet needs of chronic wound patients with common mental disorders.

BACKGROUND: Common mental disorders (CMD) are highly morbid conditions not routinely screened for in chronic wound care. A comorbid psychiatric condition's influence on a patient with chronic wounds' quality of life (QoL) is unknown. This study investigates the implications of CMD on QoL in patients with chronic lower extremity (LE) wounds. METHODS: This cross-sectional study surveyed patients with chronic LE wounds evaluated in our multidisciplinary clinic between June-July 2022. Surveys included validated physical and social QoL questionnaires, including the Lower Extremity Functional Scale (LEFS), Patient-Reported Outcomes Measurement Information System (PROMIS-3a) Scale v2.0, 12-Item Short-Form (SF-12), and a screening tool for common mental disorders, the Self-Reporting Questionnaire 20 (SRQ-20). Data regarding patient demographics, comorbidities, psychiatric diagnoses, and wound care history were retrospectively collected. RESULTS: Of the 265 identified patients, 39 (14.7%) had documented psychiatric diagnoses, most often depression or anxiety. The diagnosed cohort had higher median SRQ-20 scores (6, IQR: 6 vs. 3, IQR: 5; P < 0.001) and a higher proportion of positive screens for CMD (30.8% vs. 15.5%; P = 0.020) than non-diagnosed patients. There were no differences in physical or social QoL in patients with and without a psychiatric diagnosis. However, individuals screening positively for CMD experienced significantly more pain (T-score 60.2 vs. 51.4, P = 0.0052) and reduced function (LEFS 26.0 vs. 41.0, P < 0.0000). CONCLUSION: This study illustrates that patients with chronic LE wounds experience potentially meaningful psychologic distress. Further, symptoms of a CMD (SRQ-20 ≥8), rather than a previous diagnosis, may influence pain and functional outcomes. These findings emphasize the potential relevance of psychological distress in this population and reinforce the need for further investigation of actionable responses to this apparent need.

The Characteristics and Ethics of Sham Surgeries: A Systematic Review of Randomized Controlled Trials.

OBJECTIVE: We sought to perform a large-scale systematic review across all sham-controlled studies currently present in the literature to better characterize the ethical considerations of these studies. BACKGROUND: Innovative surgical procedures are often introduced into the clinical setting without the robust clinical trials required for medicinal treatments. Sham surgeries serve as placebos by performing all steps of a surgical intervention aside from those deemed therapeutically necessary. Yet, sham trials are underutilized because of ethical controversy. METHODS: Ovid MEDLINE was queried through April 2022 with combinations of the Medical Subject (MeSH) headings and keywords including, but not limited to, "surgery," "endoscopy," "randomized controlled trial," and "sham procedure." Primary outcomes were surgical indications and characteristics, outcome measurements, and whether the investigational treatment was offered to the sham cohort. RESULTS: One hundred seventy-two articles fit our inclusion criteria, with gastrointestinal pathologies being the most common surgical indication. Participants, personnel, and outcome assessment were all blinded in 8.7% of trials (n=15). Study populations included adult subjects (age ≥18) in 170 studies (98.8%), and two involved children. The most common level of dissection and type of anesthesia were deep (n=66, 38.4%) and general (n=49, 28.5%), respectively. An open surgical approach was utilized in 20.9% of studies (n=36). Primary outcomes were objective in 75 studies (43.6%) and subjective in 97 (56.4%), 62 of which used validated outcome measures (36.0%). Four trials explicitly did not offer the surgery to the sham arm (2.3%), whereas 106 had no mention of whether the intervention was offered (61.6%). CONCLUSIONS: Our systematic review of 172 randomized, sham-controlled trials highlights the ethical considerations that must be considered in these studies, namely the importance of transparent study design and objective outcome reporting, the difficulty of informed consent, and the inherent risks associated with surgical interventions.

The application of targeted muscle reinnervation in lower extremity amputations: A systematic review.

BACKGROUND: Targeted muscle reinnervation (TMR) is a promising surgical modality for reducing post-amputation pain. We sought to provide a succinct overview of TMR specific to the lower extremity (LE) amputation population. METHODS: A systematic review was performed per PRISMA guidelines. Ovid MEDLINE, PubMed, and Web of Science were queried for records using various combinations of Medical Subject Heading (MeSH) terms such as "LE "amputation," "below-knee amputation" (BKA), "above-knee amputation" (AKA), and "TMR." Primary outcomes included (1) operative techniques, (2) changes in neuroma, phantom limb pain (PLP), or residual limb pain (RLP), and (3) postoperative complications. Studies were only included if outcomes data were discretely provided for LE patients. RESULTS: Eleven articles examining 318 patients were identified. Average patient age was 47.5 ± 9.3 years, and most patients were male (n = 246, 77.4%). Eight manuscripts (72.7%) described TMR at the index amputation. The average number of nerve transfers performed per TMR case was 2.1 ± 0.8, and the most commonly employed nerve was the tibial (178/498; 35.7%). Nine (81.8%) articles incorporated patient-reported outcomes after TMR, with common methods including the Numerical Rating Scale (NRS) and questionnaires. Four studies (33.3%) reported functional outcomes such as ambulation ability and prosthesis tolerance. Complications were described in seven manuscripts (58.3%), with postoperative neuroma development being the most common (21/371; 7.2%). CONCLUSIONS: The application of TMR to LE amputations is effective in reducing PLP and RLP with limited complications. Continued investigations are warranted to better understand patient outcomes specific to anatomic location using validated patient-reported outcome measures (PROM).

A comparative analysis of fasciocutaneous versus muscle free flaps in peripheral vascular disease patients.

OBJECTIVE: Chronic lower extremity (LE) wounds are common in patients with peripheral vascular disease (PVD). Free tissue transfer (FTT) provides healthy soft tissue for wound coverage and additional blood supply to promote wound healing. Given previous studies demonstrate increased complications in LE fasciocutaneous flaps, it was hypothesized that low vascular resistance in muscle flaps may be more advantageous for wound healing in PVD patients. Therefore, this study compared outcomes in PVD patients undergoing LE reconstruction with fasciocutaneous versus muscle free flaps. METHODS: Retrospectively reviewed PVD patients undergoing FTT between 2011 and 2021. Patients were stratified into fasciocutaneous and muscle free flap groups. Primary outcomes included complications, flap success, post-reconstruction vascular interventions, limb salvage, and ambulatory status. RESULTS: One hundred thirteen patients with PVD were identified, of which 60.2% received fasciocutaneous (n = 68) and 39.8% received muscle flaps (n = 45). Forty-two patients (37.2%) underwent pre-flap endovascular interventions. Flap success rate was 98.2% (n = 111). Overall complication rate was 41.2% following fasciocutaneous flaps compared to 24.4% in muscle flaps (p = 0.067). Fasciocutaneous flaps had higher odds of ulceration requiring repeat angiogram within 1 year of reconstruction compared to muscle flaps (OR 3.4, 95% CI: 1.07-10.95, p = 0.047), and higher odds of requiring repeat angiogram overall (OR 3.4, 95% CI: 1.07-10.95, p = 0.047). No difference in requiring procedures in the operated limb within 1 year was observed (p = 0.155). At mean follow-up, there was no difference in limb salvage, ambulatory, and mortality rate between groups. CONCLUSION: This study demonstrates that fasciocutaneous flaps had higher postoperative complication rates and more commonly required repeat arteriograms following LE FTT reconstruction due to recurrent ulcerations, suggesting greater utility of muscle flaps for FTT reconstruction in PVD patients.