Short- and Long-term Outcomes of an Acellular Dermal Substitute versus Standard of Care in Burns and Reconstructions: A Phase I/II Intrapatient Randomized Controlled Trial.

OBJECTIVE: Dermal substitutes promote dermal regeneration and improve scar quality, but knowledge gaps remain regarding their efficacy and indications for use. The authors investigated the safety and short- and long-term efficacy of an acellular dermal substitute in patients with full-thickness wounds. METHODS: This intrapatient randomized controlled, open-label, phase I (safety) and phase II (efficacy) study compared treatment with Novomaix (Matricel GmbH), a dermal collagen/elastin-based scaffold, with split-thickness skin graft (STSG) only. The primary safety outcome was graft take at 5 to 7 days postsurgery. Postsurgical scar quality was assessed by measuring elasticity, color, and scores on the Patient and Observer Scar Assessment Scale at 3 months, 12 months, and 6 years. RESULTS: Twenty-five patients were included, of which 24 received treatment allocation. Graft take and wound healing were statistically significantly lower/delayed in the dermal matrix group compared with STSG alone (P < .004). Serious adverse events were delayed epithelialization in four dermal matrix and three STSG study areas. At 12 months postsurgery, skin extension (P = .034) and elasticity (P = .036) were better for the dermal matrix group compared with the group receiving STSG alone. Other scar quality parameters at 12 months and 6 years did not differ between treatment arms. CONCLUSIONS: The dermal substitute was a safe treatment modality for full-thickness wounds. Compared with STSG alone, time to wound healing was slightly increased. Nevertheless, scar quality at 12 months seemed somewhat improved in the wounds treated with the dermal substitute, indicative of enhanced scar maturation. In the long term, final scar quality was similar for both treatment modalities.

Mastectomy is a safe procedure in transgender men with a history of breast reduction.

Little is known about the safety and surgical outcomes of mastectomy after breast reduction in the trans male population. Several concerns have been voiced that performing mastectomy with prior breast reduction surgery, increases the risk for complications and revision surgery. All transgender men with a history of breast reduction, who underwent a mastectomy at our center between 01-1990 and 01-2021 were identified from our hospital registry. A retrospective chart study was conducted recording surgical characteristics, surgical complications, revision surgery, and clinical follow-up. A total of 1362 subcutaneous mastectomies were performed between 01-1990 and 01-2021. A total of 36 (2.6%) individuals were included (35 bilateral and 1 unilateral breast reduction). The mean age at mastectomy was 37 ± 10 years, and the median time between breast reduction and mastectomy was 6.3 years (range 1.0-31.1). Most individuals underwent a Wise-pattern breast reduction (91%) and a double incision mastectomy with free nipple grafts (86%). Following mastectomy, one acute reoperation was performed because of hemorrhage (3%). Partial pedicled nipple necrosis was seen in 7% and (partial) non-take of nipple grafts in 4%. Scar revisions were performed in 9%, dogear corrections in 20%, and both nipple corrections, and contour corrections in 6%. When comparing the outcomes in literature for surgical complications, scar revision, contour correction or nipple areolar complex revision, no clear disadvantage seems to be present when performing mastectomy after breast reduction. Mastectomy is a safe procedure in transgender men with a history of breast reduction.

An external validation of a novel predictive algorithm for male nipple areolar positioning: an improvement to current practice through a multicenter endeavor.

The correct positioning of nipple-areolar complexes (NAC) during gender-affirming mastectomies remains a particular challenge. Recently, a Dutch two-step algorithm was proposed predicting the most ideal NAC-position derived from a large cisgender male cohort. We aimed to externally validate this algorithm in a Belgian cohort. The Belgian validation cohort consisted of cisgender men. Based on patient-specific anthropometry, the algorithm predicts nipple-nipple distance (NN) and sternal-notch-to-nipple distance (SNN). Predictions were externally validated using the performance measures: R2-value, means squared error (MSE) and mean absolute percentage error (MAPE). Additionally, data were collected from a Belgian and Dutch cohort of transgender men having undergone mastectomy with free nipple grafts. The observed and predicted NN and SNN were compared and the inter-center variability was assessed. A total of 51 Belgian cisgender and 25 transgender men were included, as well as 150 Dutch cisgender and 96 transgender men. Respectively, the performance measures (R2-value, MSE and MAPE) for NN were 0.315, 2.35 (95%CI:0-6.9), 4.9% (95%CI:3.8-6.1) and 0.423, 1.51 (95%CI:0-4.02), 4.73%(95%CI:3.7-5.7) for SNN. When applying the algorithm to both transgender cohorts, the predicted SNN was larger in both Dutch (17.1measured(±1.7) vs. 18.7predicted(±1.4), p= <0.001) and Belgian (16.2measured(±1.8) vs. 18.4predicted(±1.5), p= <0.001) cohorts, whereas NN was too long in the Belgian (22.0measured(±2.6) vs. 21.2predicted(±1.6), p = 0.025) and too short in the Dutch cohort (19.8measured(±1.8) vs. 20.7predicted(±1.9), p = 0.001). Both models performed well in external validation. This indicates that this two-step algorithm provides a reproducible and accurate clinical tool in determining the most ideal patient-tailored NAC-position in transgender men seeking gender-affirming chest surgery.

The impact of incisional negative pressure wound therapy on scar quality and patient-reported outcomes: A within-patient-controlled, randomised trial.

Literature provides a moderate level of evidence for the beneficial effects of incisional negative pressure wound therapy (iNPWT) on scar quality. The purpose of this study was to establish if iNPWT results in improved scar outcomes in comparison to the standard of care. Therefore, a within-patient randomised controlled, open-label trial was conducted in transgender men undergoing gender-affirming mastectomies. A unilateral side was randomised to receive iNPWT (PICO™, Smith&Nephew) without suction drains and contrastingly the standard dressing (Steri-Strips™) with suction drain. Scar quality and questionnaires were bilaterally measured by means of objective assessments and patient-reported outcome measures (PROM) at 1, 3 and 12 months. Objective scar outcomes were scar pliability (Cutometer®), colouration (DSM-II) and scar width (3-D imaging). PROM outcomes were related to scars (POSAS and SCAR-Q) and body satisfaction (BODY-Q). From 85 included patients, 80 were included for analyses. No significant difference between treatments was seen in the quantitative outcomes of scar pliability, colour, and width. For qualitative scar outcomes, several significant findings for iNPWT were found for several subscales of the POSAS, SCAR-Q, and BODY-Q. These effects could not be substantiated with linear mixed-model regression, signifying no statically more favourable outcome for either treatment option. In conclusion, this study demonstrated that some PROM outcomes were more favourable for the iNPWT compared to standard treatment. In contrast, the quantitative outcomes showed no beneficial effects of iNPWT on scar outcomes. This suggests that iNPWT is of little benefit as a scar-improving therapy.

How Sensitive Is the Neophallus? Postphalloplasty Experienced and Objective Sensitivity in Transmasculine Persons.

INTRODUCTION: Tactile and erogenous sensitivity of the neophallus after phalloplasty is assumed to affect the sexual well-being of transmasculine persons and, ultimately, their quality of life. The experienced and objective sensation of the neophallus and their association are largely unknown. AIM: This study evaluated experienced tactile and erotic sensation of the neophallus in transmasculine persons and investigated how this was related to objective tactile sensitivity. METHODS: Between August 2017 and January 2020, 59 transmasculine persons who underwent phalloplasty were recruited to participate in a prospective follow-up study. Tactile sensitivity of the neophallus and donor-site was measured (Semmes-Weinstein Monofilament test) and compared, and participants were asked to fill out a questionnaire about experienced sensation of the neophallus and sexual wellbeing. MAIN OUTCOME MEASURES: Experienced and objective sensation of the neophallus were measured by using a questionnaire and Semmes-Weinstein Monofilament scores. RESULTS: Neophallic tactile sensitivity was significantly reduced compared to the donor-site (n = 44), with the proximal part being more sensitive than the distal part (median follow-up of 1.8 years, range 1.0-7.2)). Sensitivity of the neophallus was not significantly associated with the surgical flap used, yet increased significantly with follow-up time. The questionnaire was completed by 26 participants of which 24 (92.3%) experienced (some degree of) tactile sensitivity in their neophallus. Erogenous sensation was experienced by 23 (88.5%). Experienced and objectified tactile sensitivity were not significantly correlated (Spearmans's rho = 0.23, P = .26). Answers to open-ended questions showed that results often do not match expectations. CONCLUSION: Tactile sensation of the neophallus was reduced in most transmasculine persons and improved slowly over time. A significant association between subjective and objective measures could not be detected. Although experienced sensitivity varied between individuals, the vast majority reported to have tactile and erotic sensitivity in the neophallus.Transmasculine persons should be informed that sensitivity of the neophallus will likely be reduced. Elfering L, van de Grift TC, Al-Tamimi M, et al. How Sensitive Is the Neophallus? Postphalloplasty Experienced and Objective Sensitivity in Transmasculine Persons. Sex Med 2021;9:100413.

Long-term Follow-up and Trends in Breast Augmentation in 527 Transgender Women and Nonbinary Individuals: A 30-year experience in Amsterdam.

BACKGROUND: Transgender women and transfeminine spectrum nonbinary individuals may opt for breast augmentation. The aim of the study is to analyze the complications, surgical trends, and long-term follow-up of breast augmentations in this population over the past 30 years. METHODS: All transgender women and nonbinary individuals who underwent breast augmentation at our center between 01-1990 and 01-2020 were retrospectively identified. A retrospective chart study was conducted, recording individual demographics, implant characteristics, surgical timing, postoperative complications or other reasons requiring reoperation, and implant survival. A literature search was performed in MEDLINE on clinical outcomes and revision surgery of this procedure. RESULTS: A total of 527 individuals were identified. Median clinical follow-up time was 11.2 years (interquartile range 3.3-17.5). Median implant size increased significantly over the last years (1990-1990 median 275cc, 2000-2009 252cc, 2010-2019 375cc, p<0.01). Most individuals underwent breast augmentation and genital gender-affirming surgery in one-stage. Reoperations due to short-term complications were infrequent (hematoma (0.4%) or infection (0.4%)). Reoperations due to long-term complications comprised: implant rupture (5.7%), capsular contracture (4.9%), aesthetic problems (3.8%), low-grade infection (0.4%), or seroma (0.6%). In total, 2.5% of individuals requested larger implants. After performing the literature search and manuscript screening, 9 out of 115 identified studies were included for review. Follow-up time ranged from 30 days to 5.5 years. Reported complications requiring reoperation were capsular contraction (range 0.0-5.6%), asymmetry (3.6%), hematoma (range 0.0-2.9%), infection (range 0.0-0.9%) and implant rupture (0.7%), CONCLUSION: Implant-based breast augmentation is a safe procedure in transgender individuals.

Sustained Breast Development and Breast Anthropometric Changes in 3 Years of Gender-Affirming Hormone Treatment.

CONTEXT: Breast development is important for most trans women. An important limitation of current breast development measurement methods is that these do not allow for 3D volume analyses. OBJECTIVES: To examine breast development and change in anthropometry during the first 3 years of gender-affirming hormone treatment using 3D imaging. Associations with clinical or laboratory parameters and satisfaction with the gained breast development were also studied. DESIGN: Prospective cohort study. SETTING: Specialized tertiary gender identity clinic in Amsterdam, the Netherlands. PARTICIPANTS: Participants were 69 adult trans women with a median age of 26 years (interquartile range, 21-38). INTERVENTIONS: Gender-affirming hormone treatment. MAIN OUTCOME MEASURES: Volumetric and anthropometric breast development and satisfaction. RESULTS: Breast volume increased by 72 cc (95% confidence interval [CI], 48-97) to 100 cc (standard deviation 48). This resulted in a cup-size

A systematic review evaluating the influence of incisional Negative Pressure Wound Therapy on scarring.

Pathological scars can result in functional impairment, disfigurement, a psychological burden, itch, and even chronic pain. We conducted a systematic review to investigate the influence of incisional Negative Pressure Wound Therapy (iNPWT) on scarring. PubMed, EMBASE and CINAHL were searched for preclinical and clinical comparative studies that investigated the influence of iNPWT on scarring-related outcomes. Individual studies were assessed using the OHAT Risk of Bias Rating Tool for Human and Animal studies. The body of evidence was rated using OHAT methodology. Six preclinical studies and nine clinical studies (377 patients) were identified. Preclinical studies suggested that iNPWT reduced lateral tension on incisions, increased wound strength, and reduced scar width upon histological assessment. Two clinical studies reported improved patient-reported scar satisfaction as measured with the PSAS (1 year after surgery), POSAS, and a VAS (both 42, 90, and 180 days after surgery). Five clinical studies reported improved observer-reported scar satisfaction as measured with the VSS, SBSES, OSAS, MSS, VAS, and POSAS (7, 15, 30, 42, 90, 180, and 365 days after surgery). Three clinical studies did not detect significant differences at any point in time (POSAS, VAS, and NRS). Because of imprecision concerns, a moderate level of evidence was identified using OHAT methodology. Preclinical as well as clinical evidence indicates a beneficial influence of iNPWT on scarring. Moderate level evidence indicates that iNPWT decreases scar width and improves patient and observer-reported scar satisfaction.

Gender-Confirming Vulvoplasty in Transgender Women in the Netherlands: Incidence, Motivation Analysis, and Surgical Outcomes.

BACKGROUND: Penile inversion vaginoplasty is the surgical gold standard for genital gender-affirmative surgery in transgender women. However, there is an increase of attention for gender-confirming vulvoplasty (GCV), in which no neovaginal cavity is created. AIM: To describe underlying motives and surgical outcomes of GCV in transgender women. METHODS: All transgender women who underwent GCV were retrospectively identified from a departmental database. A retrospective chart study was conducted, recording underlying motives, demographics, perioperative complications, and reoperations. OUTCOMES: Underlying motives and perioperative complication rate. RESULTS: In the period January 1990 to January 2020, 17 transgender women underwent GCV at our center. Most women reported that their motivation to undergo GCV was because they had no wish for postoperative neovaginal penetration (n = 10, 59%). This was due to a sexual preference toward women without the wish for neovaginal penetrative intercourse (n = 6, 35%) or due to a negative sexual experience in the past (n = 4, 24%). Some women desired vaginoplasty with neovaginal cavity creation but were ineligible for this because of their medical history (n = 4, 24%), for example, due to locoregional radiotherapy. The median clinical follow-up was 34 months (range 3-190). The postoperative course was uncomplicated in 11 (65%) women. Postoperative complications comprised the following: meatal stenosis (n = 2, for which surgical correction), remnant corpus spongiosum tissue (n = 1, for which surgical correction), minor wound dehiscence (n = 3, for which conservative management), and postoperative urinary tract infection (n = 1, successfully treated with oral antibiotics). One woman, who developed meatal stenosis, had a history of radiotherapy because of rectal carcinoma and needed 2 surgical procedures under general anesthesia to correct this. Information on self-reported satisfaction was available for 12 women. All were satisfied with the postoperative result and they graded their neovagina an 8.2 ± 0.9 out of 10. CLINICAL IMPLICATIONS: GCV may be added to the surgical repertoire of the gender surgeon. Transgender women with a desire for genital gender-affirmative surgery should be counseled on surgical options and its (dis)advantages. STRENGTHS & LIMITATIONS: Strengths of this study comprise that it is from a high-volume center. A weakness of this study is the retrospective design. The absence of a self-reported outcome measure validated for the transgender persons is a well-known problem. CONCLUSION: An increase is observed in transgender women who opt for GCV; however, the absolute number undergoing this surgery remains small in our center. Postoperative complications do occur but are generally minor and treatable. van der Sluis WB, Steensma TD, Timmermans FW, et al. Gender-Confirming Vulvoplasty in Transgender Women in the Netherlands: Incidence, Motivation Analysis, and Surgical Outcomes. J Sex Med 2020;17:1566-1573.

Correction: An insight into circumcised men seeking foreskin reconstruction: a prospective cohort study.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

'An insight into circumcised men seeking foreskin reconstruction: a prospective cohort study'.

The aim of this study was to present a cohort of men seeking assistance with foreskin reconstruction, with the objective to broaden the general understanding for this specific request. All men between January 2015 and May 2019 seeking assistance with foreskin reconstruction were included. We prospectively collected data on patient demographics and outcomes such as their motivations, treatment trajectory, and experiences. A total of 11 patients were identified and included (age range 20-62). The majority were circumcised during adulthood for medical reasons. Among the most prominent motivations to pursue reconstruction were experiencing impairment of body integrity, feeling mutilated, increasing glans sensitivity and having issues with an imposed cultural or religious identity. Most patients stated that they experienced little support from healthcare professionals and that the Internet was their main source of information. Furthermore, almost all patients practiced penile tissue stretching to reconstruct the foreskin with unregistered devices. Foreskin reconstruction is a scarcely reported topic and is sought out for different reasons. Although rare, these patients experience a heavy burden and will go to great lengths to reconstruct their foreskin, more often so without the involvement of healthcare professions. In contrary to the surgical treatment options, the nonsurgical methods seem promising, but these rely heavily on lay-sources found online.

A retrospective investigation of abdominal visceral fat, body mass index (BMI), and active smoking as risk factors for donor site wound healing complications after free DIEP flap breast reconstructions.

BACKGROUND: The deep inferior epigastric artery perforator (DIEP) flap is one of the most common techniques for breast reconstruction. Body mass index (BMI) is considered as an important predictor of donor site healing complications such as wound dehiscence. The use of computed tomography (CT) proved to be a precise and objective method to assess visceral adipose tissue. It remains unclear whether quantification of visceral fat provides more accurate predictions of abdominal wound healing complications than BMI. PATIENTS AND METHODS: A total of 97 patients with DIEP flap were retrospectively evaluated. Patients' abdominal visceral fat (AVF) was quantified on CT angiography (CTA). The patients were postoperatively assessed for abdominal wound healing complications. We analyzed for the correlations between AVF, BMI, and dehiscence and established a logistic regression model to assess the potential high-profile predictors in anatomic and patient characteristics such as weight, smoking, and diabetes. RESULTS: We included 97 patients, and of them, 24 patients (24.7%) had some degree of abdominal dehiscence. No significant differences were observed between the dehiscence group and the non-dehiscence group, except for smoking (p = 0.002). We found a significant correlation between AVF and BMI (R = 0.282, p = 0.005), but neither was significant in predicting donor site dehiscence. Smoking greatly increased the likelihood of developing wound dehiscence (OR = 11.4, p = < 0.001). CONCLUSIONS: AVF and BMI were not significant predictors of abdominal wound healing complications after DIEP flap reconstruction. This study established active smoking (OR = 11.4, p = < 0.001) as the significant risk factor that contributed to the development of abdominal wound dehiscence in patients with DIEP.