Assessing antibacterial efficacy of a polyhexanide hydrogel versus alginate-based wound dressing in burns.

OBJECTIVE: Burn injuries pose a heightened risk of infection, which is primarily responsible for increased morbidity and mortality. Factors such as extensive skin damage and compromised immunity exacerbate this vulnerability. Pseudomonas aeruginosa and Staphylococcus aureus are frequently identified in burns, with Gram-negative Pseudomonas aeruginosa often resistant to antibacterial agents. While Flaminal, an alginate-based wound dressing (Flen Health, Belgium), aids wound healing, its antibacterial effects are limited compared with 1% silver sulfadiazine (1% SSD). In contrast, Prontosan Wound Gel X, a betaine and polyhexanide-based hydrogel (B. Braun Medical AG, Switzerland), has been shown to effectively combat various microbes and promotes wound healing. METHOD: In this study, two research cohorts were retrospectively established (control group: patients receiving standard of care with the alginate-based wound dressing; intervention group: patients receiving the polyhexanide hydrogel wound dressing), comprising patients admitted to a burn centre between 2019 and 2022. Patients were eligible when continuous wound treatment with either of the two wound dressings was performed. Laser Doppler imaging (LDI) scans were conducted. Regions of interest (ROIs) were selected based on LDI scans and divided into healing time categories. Wound swabs were collected and the presence of Pseudomonas aeruginosa and Staphylococcus aureus was documented. Bacterial load was evaluated using a semiquantitative scale. Wound healing was recorded. RESULTS: The control group consisted of 31 patients with 93 ROIs, while the intervention group had 67 ROIs involving 29 patients. Both groups exhibited similar proportions of healing time categories (p>0.05). The polyhexanide hydrogel dressing outperformed the alginate-based dressing in antiseptic efficacy by significantly reducing the incidence of Pseudomonas aeruginosa- and Staphylococcus aureus-positive cultures in patients' wounds. Wound healing time for conservative treatment was comparable between groups. CONCLUSION: In this study, the polyhexanide hydrogel dressing minimised Pseudomonas aeruginosa and Staphylococcus aureus colonisation in burn wounds, demonstrating strong antibacterial properties, emphasising its potential to minimise infections in burn injuries.

Botulinum toxin A treatment in facial palsy synkinesis: a systematic review and meta-analysis.

BACKGROUND: Synkinesis is defined as involuntary movements accompanying by voluntary movements and can occur during the aftermath of peripheral facial palsy, causing functional, aesthetic and psychological problems in the patient. Botulinum toxin A (BTX-A) is frequently used as a safe and effective treatment; however, there is no standardized guideline for the use of BTX-A in synkinesis. The purpose of this article is to review and summarize studies about the BTX-A treatment of synkinesis in patients with a history of peripheral facial palsy; including given dosages, injection sites and time intervals between injections. MATERIALS AND METHODS: A multi-database systematic literature search was performed in October 2020 using the following databases: Pubmed, Embase, Medline, and The Cochrane Library. Two authors rated the methodological quality of the included studies independently using the 'Newcastle-Ottawa Quality Assessment Scale' for non-randomised studies' (NOS). RESULTS: Four-thousand-five-hundred-and-nineteen articles were found of which 34 studies met the inclusion criteria, in total comprising 1314 patients. Most studies were assessed to be of 'fair' to 'good' methodological quality. The Cohen's kappa (between author FJ and AS) was 0.78. Thirty-one studies investigated the reported dosage injected, 17 studies reported injection location and 17 studies investigated time intervals. A meta-analysis was performed for three studies comprising 106 patients, on the effects of BTX-A treatment on the Synkinesis Assessment Questionnaire (SAQ) scores. The mean difference was 11.599 (range 9.422-13.766), p < 0.01. However, due to inconsistent reporting of data of the included studies, no relationship with the dosage and location could be assessed. CONCLUSIONS: Many treatment strategies for synkinesis exist, consisting of varying BTX-A brands, dosages, time intervals and different injection locations. Moreover, the individual complaints are very specific, which complicates creating a standardized chemodenervation treatment protocol. The BTX-A treatment of long-term synkinesis is very individual and further studies should focus on a patient-tailored treatment instead of trying to standardize treatment.

Enzymatic Deglycation of Damaged Skin by Means of Combined Treatment of Fructosamine-3-Kinase and Fructosyl-Amino Acid Oxidase.

The consensus in aging is that inflammation, cellular senescence, free radicals, and epigenetics are contributing factors. Skin glycation through advanced glycation end products (AGEs) has a crucial role in aging. Additionally, it has been suggested that their presence in scars leads to elasticity loss. This manuscript reports fructosamine-3-kinase (FN3K) and fructosyl-amino acid oxidase (FAOD) in counteracting skin glycation by AGEs. Skin specimens were obtained (n = 19) and incubated with glycolaldehyde (GA) for AGE induction. FN3K and FAOD were used as monotherapy or combination therapy. Negative and positive controls were treated with phosphate-buffered saline and aminoguanidine, respectively. Autofluorescence (AF) was used to measure deglycation. An excised hypertrophic scar tissue (HTS) (n = 1) was treated. Changes in chemical bonds and elasticity were evaluated using mid-infrared spectroscopy (MIR) and skin elongation, respectively. Specimens treated with FN3K and FAOD in monotherapy achieved an average decrease of 31% and 33% in AF values, respectively. When treatments were combined, a decrease of 43% was achieved. The positive control decreased by 28%, whilst the negative control showed no difference. Elongation testing of HTS showed a significant elasticity improvement after FN3K treatment. ATR-IR spectra demonstrated differences in chemical bounds pre- versus post-treatment. FN3K and FAOD can achieve deglycation and the effects are most optimal when combined in one treatment.

The process to obtain reimbursement for enzymatic debridement in clinically deep burns.

INTRODUCTION: Burn eschar removal by enzymatic debridement with NexoBrid® (EDNX) results in a maximum preservation of all viable tissue, which is the main advantage over traditional tangential excision. The authors participated in a marketing authorization holder process to obtain reimbursement from the national health authorities in Belgium. MATERIAL AND METHODS: The reimbursement process consisted of three phases, as specified by the reimbursement regulations required by the Belgian National Institute for Health and Disability Insurance (NIHDI). RESULTS: Forty-one patients with clinically deep 2nd and 3rd degree burns, treated with EDNX in two Belgian burn centers, were included in the registry for the first phase of the reimbursement process. The total success rate of the EDNX treatment was 95.1% (39/41). Over half of the burn wounds treated with NexoBrid® (55.2%) did not require any additional surgical debridement or skin grafting. To obtain definitive reimbursement, an extra 16 patients were included. In this population, 51.4% did not require any surgical intervention. The total success rate of the EDNX debridement in this group was 100%. Based on an estimated market share of 12% and around 75 patients in the third year after final reimbursement, a market access consultant calculated that NexoBrid® will realize yearly savings for the Belgian Healthcare budget of at least €30.000. CONCLUSION: Based on the results of this Belgian registry study in combination with the yearly healthcare budget savings, the NIHDI granted a final reimbursement for EDNX treatment in adults, endorsed by the Minister of Health on November 5th, 2019.

Enzymatic debridement: past, present, and future.

INTRODUCTION: Early surgical debridement of the deep second and third-degree burns is still the standard of care (SOC) to prepare the wound bed for skin grafting. However, this technique has some drawbacks that explain the growing interest in enzymatic debridement as an alternative. In this article, we provide a historic overview as well as the current state-of-the-art and future prospective of this type of non-surgical debridement. MATERIALS AND METHODS: A narrative review of the available literature was conducted using a systematic search. RESULTS: A total of 32 articles were included. The only enzyme mixture still used nowadays for burn eschar removal is bromelain-based. There is increasing evidence that this type of enzymatic debridement is a powerful tool to selectively remove the eschar in deep burns, thereby reducing the need for autologous skin grafting compared to surgical SOC. Moreover, off-label use of enzymatic debridement with NexoBrid® (facial, pediatric, and >15%TBSA burns) has proven to be effective and safe. CONCLUSION: There is increasing evidence that bedside administered NexoBrid®, preferably under regional anesthesia, is a powerful tool for selective burn eschar removal. However, the clinical wound bed evaluation post-NexoBrid® procedure in relation to the optimal treatment decision-conservative treatment vs. surgery-is not yet completely elucidated. More high-quality prospective clinical trials are necessary to compare enzymatic debridement of objectively confirmed deep burns with the current standard treatment and assess the effectiveness of the eschar removal, the need for surgery, the healing time of such wounds, and the long-term scar quality.

Fat Embolism After Autologous Facial Fat Grafting.

BACKGROUND: Autologous facial fat grafting has gained popularity in recent years and is considered to be safe. This paper presents the case of a patient who died due to massive cerebral microfat embolism after facial fat grafting. OBJECTIVES: The aim of this study was to raise awareness and provide more evidence on the prevention and treatment of this potentially lethal complication of facial fat grafting. METHODS: A detailed report was made of the case. Two online databases were searched for similar cases of facial fat embolism resulting in neurologic and/or visual symptoms. Thereafter a literature search was conducted to verify the etiology, current treatment options, and preventive measures. RESULTS: Forty-nine cases with similar events were found in the literature. The most common injected area was the glabella (36.1%), and an average of 16.7 mL fat was injected. The main complications were visual impairment, with 88.5% of cases resulting in permanent monocular blindness, and neurologic symptoms, some of which never fully recovered. Including the present patient, 7 cases were fatal. Fat embolism can occur in the veins and arteries of the face. Two possible pathways for fat embolism exist: the macroscopic, mechanical pathway with immediate signs, and the microscopic, biochemical pathway with delayed symptoms. Mechanical embolectomy and corticosteroids are suggested treatment options but evidence for their efficacy is lacking. Several different preventive measures are described. CONCLUSIONS: Although facial fat grafting is considered a safe procedure, one should be aware of the risk of fat embolism. Underreporting of this adverse event is likely. With no effective treatment and often detrimental outcomes, preventive measures are of utmost importance to improve patient safety.

Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes.

BACKGROUND: Until recently, all available erectile devices were manufactured in accordance with the anatomy of a native penis and led to high explantation rates when implanted in the neophallus. AIM: The aim of this study was to investigate surgical outcomes after implantation of the ZSI 475 FTM in the neophallus; this is the first erectile device specifically manufactured for implantation after phalloplasty. METHODS: This is a prospective observational study of patients undergoing implantation of the ZSI 475 FTM in the neophallus at a tertiary referral center since September 2017. Patients with a follow-up < 3 months were excluded from this analysis. OUTCOMES: Intraoperative and postoperative complications were analyzed with descriptive statistics and explantation-free survival was assessed using a Kaplan-Meier survival analysis. RESULTS: In total, 57 patients were included with a median (IQR) follow-up of 16 (10-21) months. No intraoperative complications occurred. Postoperative complications were seen in 18 of 57 (32%) patients and included cylinder protrusion (1/57, 1.8%), infection (8/57, 14%), malpositioning (4/57, 7.0%), mechanical failure (4/57, 7.0%), and urinary retention (1/57, 1.8%). A total of 13 of 57 (23%) devices were explanted which corresponds with an estimated explantation-free survival rate (SD) of 84% (4.9), 80% (5.6), and 80% (5.6) after, respectively, 6, 12, and 18 months of follow-up. CLINICAL IMPLICATIONS: By better addressing the specific needs after phalloplasty, this innovative erectile device might lead to improved cylinder protrusion, malpositioning, and mechanical failure rates, but device infection remains common. STRENGTHS & LIMITATIONS: This is the largest study on this topic to date and the first to report prospective data. Main limitations involve the relatively small sample size and the limited follow-up. CONCLUSION: Short-term cylinder protrusion, malpositioning, and mechanical failure rates are encouraging, although device infection remains a common problem. These complications resulted in a device explantation rate of 23%. Verla W, Goedertier W, Lumen N, et al. Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes. J Sex Med 2021;18:615-622.

Update on the role of antiseptics in the management of chronic wounds with critical colonisation and/or biofilm.

Biofilms play a major role in delaying chronic wounds from healing. A wound infiltrated with biofilm, or "critically colonised" wound, may become clinically infected if the number of microbes exceeds a critical level. Chronic wound biofilms represent a significant treatment challenge by demonstrating recalcitrance towards antimicrobial agents. However, a "window of opportunity" may exist after wound debridement when biofilms are more susceptible to topical antiseptics. Here, we discuss the role of antiseptics in the management of chronic wounds and biofilm, focusing on povidone-iodine (PVP-I) in comparison with two commonly used antiseptics: polyhexanide (PHMB) and silver. This article is based on the literature reviewed during a focus group meeting on antiseptics in wound care and biofilm management, and on a PubMed search conducted in March 2020. Compared with PHMB and silver, PVP-I has a broader spectrum of antimicrobial activity, potent antibiofilm efficacy, no acquired bacterial resistance or cross-resistance, low cytotoxicity, good tolerability, and an ability to promote wound healing. PVP-I represents a viable therapeutic option in wound care and biofilm management, with the potential to treat biofilm-infiltrated, critically colonised wounds. We propose a practical algorithm to guide the management of chronic, non-healing wounds due to critical colonisation or biofilm, using PVP-I.

Enzymatic debridement as an effective treatment for combined flame and chemical burns caused by e-cigarettes.

Since its introduction on the market in 2007, the number of reports on injuries caused by the ignition or explosion of electronic nicotine delivery systems (ENDS) has increased significantly. Two male patients have been treated at our burn center, the for ENDS-related injuries. Their batteries came into contact with metal objects stored in their pants pockets, resulting in a short circuit and finally ignition. In both patients, the combined flame and chemical burn wounds were initially irrigated with water upon arrival at the emergency department, leading to increased levels of pain. In our burn center, the wounds were extensively cleansed which led to a subsequent drop in NRS-scores. Laser Doppler Imaging showed a clear indication for surgery as both patients suffered a partial-thickness burn, with one patient having a patch of full-thickness burn as well. We swiftly performed an enzymatic debridement in both patients, followed by conservative wound management. Although enzymatic debridement is not generally recommended in the treatment of chemical burns, we successfully made use of this treatment option. Different authors advocate the use of mineral oils to irrigate or cover alkali burns, as contact between the chemical compounds and water can set off an exothermic reaction, leading to further injury. We believe that a hypertonic rinsing solution could be recommended as well in an emergency setting and we want to stress the importance of rapid removal of the chemical compounds in suspected chemical burns as well as swift debridement.

Free Bipedicled Radial Forearm and Posterior Interosseous Artery Perforator Flap Phalloplasty.

INTRODUCTION: The free radial forearm (FRFA) flap is universally still considered as the gold standard technique in penile reconstruction. Typically, a considerably large flap is required, often involving almost the entire circumference of the forearm. Partial necrosis may occur at the distal-most (dorsoradial) part of the flap as a result of insufficient perfusion. AIM: To describe a new technique using the posterior interosseous artery (PIOA) to supercharge FRFA phalloplasty. METHODS: In a 12-month period, all patients having FRFA flap phalloplasty were enrolled. Perioperative, after complete flap dissection, an indocyanine green perfusion scan was performed. In case of insufficient perfusion at the distalmost part of the flap, a supramicrosurgical anastomosis was performed between the FRFA pedicle and the PIOA (artery only). MAIN OUTCOME MEASURES: Studied outcomes included the rate of marginal necrosis, surgical time, postoperative posterior interosseous nerve damage and urethral complications (fistula, stenosis or necrosis). RESULTS: A total of 27 FRFA flap phalloplasties was performed. Anastomosis of the PIOA was needed in 15 cases. No marginal necrosis was observed in these cases. There were no cases of postoperative posterior interosseous nerve damage. There were no significant differences in urethral complications (fistula, stenosis or necrosis) between the 2 groups. CLINICAL IMPLICATIONS: In selected cases where insufficient perfusion of the dorsoradial part of the flap is present, patients may benefit from arterial supercharging to prevent postoperative marginal necrosis. STRENGTH & LIMITATIONS: Strengths include a single surgeon, thus lending continuity of skill and technique, a consecutive series, and 100% short-term follow-up. Limitations include single institution series and a limited number of patients. CONCLUSION: Arterial supercharging is effective in improving perfusion of large FRFA flaps used in phalloplasty when dorsoradial hypoperfusion is detected on an indocyanine green perfusion scan. It is a technically challenging addition to the standard technique because of the small size of the vessels, the close relationship between the PIOA and the posterior interosseous nerve, and the vulnerability of the newly constructed intra-flap anastomosis. De Wolf E, Claes K, Sommeling CE, et al. Free Bipedicled Radial Forearm and Posterior Interosseous Artery Perforator Flap Phalloplasty. J Sex Med 2019;16:1111-1117.

The Surgical Techniques and Outcomes of Secondary Phalloplasty After Metoidioplasty in Transgender Men: An International, Multi-Center Case Series.

INTRODUCTION: Some transgender men express the wish to undergo genital gender-affirming surgery. Metoidioplasty and phalloplasty are procedures that are performed to construct a neophallus. Genital gender-affirming surgery contributes to physical well-being, but dissatisfaction with the surgical results may occur. Disadvantages of metoidioplasty are the relatively small neophallus, the inability to have penetrative sex, and often difficulty with voiding while standing. Therefore, some transgender men opt to undergo a secondary phalloplasty after metoidioplasty. Literature on secondary phalloplasty is scarce. AIM: Explore the reasons for secondary phalloplasty, describe the surgical techniques, and report on the clinical outcomes. METHODS: Transgender men who underwent secondary phalloplasty after metoidioplasty were retrospectively identified in 8 gender surgery clinics (Amsterdam, Belgrade, Bordeaux, Austin, Ghent, Helsinki, Miami, and Montreal). Preoperative consultation, patient motivation for secondary phalloplasty, surgical technique, perioperative characteristics, complications, and clinical outcomes were recorded. MAIN OUTCOME MEASURE: The main outcome measures were surgical techniques, patient motivation, and outcomes of secondary phalloplasty after metoidioplasty in transgender men. RESULTS: Eighty-three patients were identified. The median follow-up was 7.5 years (range 0.8-39). Indicated reasons to undergo secondary phalloplasty were to have a larger phallus (n = 32; 38.6%), to be able to have penetrative sexual intercourse (n = 25; 30.1%), have had metoidioplasty performed as a first step toward phalloplasty (n = 17; 20.5%), and to void while standing (n = 15; 18.1%). Each center had preferential techniques for phalloplasty. A wide variety of surgical techniques were used to perform secondary phalloplasty. Intraoperative complications (revision of microvascular anastomosis) occurred in 3 patients (5.5%) undergoing free flap phalloplasty. Total flap failure occurred in 1 patient (1.2%). Urethral fistulas occurred in 23 patients (30.3%) and strictures in 27 patients (35.6%). CLINICAL IMPLICATIONS: A secondary phalloplasty is a suitable option for patients who previously underwent metoidioplasty. STRENGTHS & LIMITATIONS: This is the first study to report on secondary phalloplasty in collaboration with 8 specialized gender clinics. The main limitation was the retrospective design. CONCLUSION: In high-volume centers specialized in gender affirming surgery, a secondary phalloplasty in transgender men can be performed after metoidioplasty with complication rates similar to primary phalloplasty. Al-Tamimi M, Pigot GL, van der Sluis WB, et al. The Surgical Techniques and Outcomes of Secondary Phalloplasty After Metoidioplasty in Transgender Men: An International, Multi-Center Case Series. J Sex Med 2019;16:1849-1859.

A New Technique for Coronaplasty in Penile Reconstruction.

BACKGROUND: The coronaplasty is an important step of the phalloplasty procedure as it creates a prominent coronal ridge and a constricted coronal sulcus, resulting in the transformation of a regular skin flap into a flap resembling a circumcised penis. AIM: The aim of this article is to describe our new coronaplasty technique that exploits opposing contracting forces of 2 different skin grafts to hold the shape of a thick, distally based skin flap, resulting in a natural looking neo-phallus. METHODS: A distally based flap is raised at the junction of the middle and distal thirds of the neo-phallus. The dissection continues until adequate mobilization is obtained, so the flap can stand almost perpendicular to the axis of the shaft. 2 separate full-thickness skin grafts are harvested and placed: the first at the raw undersurface of the flap, the second at the flap's donor site. To make the sulcus deeper and to define the ridge, the lower part of the graft placed on the undersurface of the distal flap is sutured with tacking sutures. Depending on the type of flap used this procedure can be done during the phalloplasty procedure itself (axial flaps) or at least 1 week later (perforator flaps). OUTCOMES: The new technique that we developed shows a more distinct coronal sulcus and coronal ridge, long-lasting results, and a more aesthetically pleasing and natural-appearing glans penis. RESULTS: The harvested distal flap is progressively thicker and not folded, resulting in a more naturally looking ridge. The donor site is deeper than other techniques, creating a well-defined sulcus. By using 2 skin grafts the opposing force vectors increase the projection of the ridge and the deepness of the sulcus. CLINICAL TRANSLATION: This technique results in a more prominent glans penis and is an important step in creating an almost naturally looking neo-phallus. CONCLUSIONS: This procedure can be applied to all different kind of flaps used for phalloplasty, both in an immediate or delayed fashion. As grafts are used, partial or complete graft lost can appear. Furthermore, attention must be paid not to incise the distal flap too deep so vascularity to the distal part of the flap will not be impaired. A continuous search to optimize the aesthetic outcome of the phalloplasty procedure is necessary and with this new coronaplasty technique we hope to raise attention and take another step toward creating "the real thing." Sommeling CE, De Wolf EJ, Salim A, et al. A New Technique for Coronaplasty in Penile Reconstruction. J Sex Med 2018;15:920-923.

Gender Confirmation Surgery: Guiding Principles.

BACKGROUND: At this time, no formal training or educational programs exist for surgeons or surgery residents interested in performing gender confirmation surgeries. AIM: To propose guiding principles designed to aid with the development of formal surgical training programs focused on gender confirmation surgery. METHODS: We use expert opinion to provide a "first of its kind" framework for training surgeons to care for transgender and gender nonconforming individuals. OUTCOMES: We describe a multidisciplinary treatment model that describes an educational philosophy and the institution of quality parameters. RESULTS: This article represents the first step in the development of a structured educational program for surgical training in gender confirmation procedures. CLINICAL IMPLICATIONS: The World Professional Association for Transgender Health Board of Directors unanimously approved this article as the framework for surgical training. STRENGTHS AND LIMITATIONS: This article builds a framework for surgical training. It is designed to provide concepts that will likely be modified over time and based on additional data and evidence gathered through outcome measurements. CONCLUSION: We present an initial step in the formation of educational and technical guidelines for training surgeons in gender confirmation procedures. Schechter LS, D'Arpa S, Cohen MN, et al. Gender Confirmation Surgery: Guiding Principles. J Sex Med 2017;14:852-856.

Sexual quality of life after total phalloplasty in men with penile deficiency: an exploratory study.

PURPOSE: Total phalloplasty is rarely performed today in males with severe penile deficiency, despite its successful use in the transgender population. Can phalloplasty replicate the complexity of penile anatomy and function on the long term? METHODS: Sexual quality of life (QoL) was assessed in 10 men (aged 20-43 years) at least 1 year after phalloplasty in a single institution (80 % radial forearm flap and 20 % anterolateral thigh flap). In all but one, an erectile prosthesis was implanted on average 1 year after phallic reconstruction. Sexual QoL outcomes were compared to those of men with hypospadias repair (n = 73) and control men (n = 50). RESULTS: After phalloplasty (mean 36.9 months, 14-92 months), all men were sexually active (80 % intercourse and 100 % masturbation with orgasm and ejaculation). However, 75 % indicated to be inhibited in seeking sexual contacts, compared to 40 % of hypospadias patients (p < 0.05) and 11 % of controls (p < 0.01). Although 90 % were satisfied with the final surgical result, dissatisfaction with some aspects of genital appearance was present in 50 %. Erogenous neophallus sensitivity was said to be less than previously hoped for. Six men developed urinary complications (urethral stricture and/or fistula), and one man underwent revision of the erectile implant because of dysfunction. Nevertheless, all indicated they would choose again for phalloplasty if necessary. CONCLUSIONS: Total phalloplasty opens new horizons for the treatment of men with penile deficiency, but limitations of the technique should be emphasized prior to surgery. An exploration of patient expectations and continued follow-up including psychological support is important for optimizing psychosexual comfort.

Vaginal dilation treatment in women with vaginal hypoplasia: a prospective one-year follow-up study.

OBJECTIVE: Vaginal dilation treatment has been shown to be a (cost) effective first-line alternative to surgery in normalizing vaginal length and improving sexual function in women with vaginal hypoplasia. There remains, however, a need for prospective studies, with long-term assessment of multiple outcomes. STUDY DESIGN: This was a prospective, single-centre observational study of 16 women with Mayer-Rokitansky-Küster-Hauser syndrome (n = 12) or 46,XY disorders of sex development (n = 4). All women underwent an outpatient vaginal dilation program supervised by a psychologist and physiotherapist. At baseline (T0), stop of treatment (T1) and 1 year follow-up (T2), semistructured interviews, and validated questionnaires assessed sexual function and distress, self-esteem, vaginal perceptions, and health-related quality of life. Gynecological examinations evaluated vaginal dimensions. RESULTS: Ten women completed the program, 3 are still in the program, and dilation failed in 3 and chose vaginoplasty. Sixty-nine percent reached a normal vaginal length (≥6.5 cm) in 5.8 ± 3.3 months. Seventy percent were sexually active with pleasurable experiences at T1, 57% at T2. The significant decrease in sexual distress at T1 (P < .05) was followed by a nonsignificant increase at T2. Depressive mood symptomatology remained high at T1 and T2, related to loss of bodily integrity and fertility. The majority refused further psychological counseling. CONCLUSION: Vaginal dilation treatment should remain the cornerstone of treatment in women with vaginal hypoplasia. However, the diagnosis remains to have a negative impact on emotional well-being in the long term. The role of psychological intervention as both a primary and adjuvant treatment needs clear evaluation.

Hormonal and surgical treatment in trans-women with BRCA1 mutations: a controversial topic.

INTRODUCTION: Male-to-female transgender persons (trans-women) receive livelong cross-sex hormonal treatment in order to induce and maintain secondary female characteristics. One of the concerns of long-term estrogen treatment is the induction of carcinomas of estrogen-sensitive tissues such as the breast. BRCA1 mutations have been shown to account for a large proportion of inherited predispositions to breast cancer. AIM: The aim of this case report is to discuss the hormonal and surgical options in the treatment of trans-women with a genetic predisposition for breast cancer. METHOD: We describe a case of a trans-woman who was found to be a carrier of a BRCA1 mutation. RESULTS: The patient underwent a breast augmentation. She refused a prophylactic mastectomy followed by a primary breast reconstruction. She also underwent a vaginoplasty and a bilateral castration. Androgen blocking treatment was stopped after surgery; estradiol treatment however was continued. CONCLUSIONS: This case points to the importance of routine investigation of family history in trans-women. Trans-women with BRCA mutations should be carefully monitored and if cancers develop, this should be reported. Follow-up should be according to the guidelines for breast cancer screening in biological women, and the guidelines for prostate cancer and colon cancer screening in men.

Sexual desire in trans persons: associations with sex reassignment treatment.

INTRODUCTION: Sex steroids and genital surgery are known to affect sexual desire, but little research has focused on the effects of cross-sex hormone therapy and sex reassignment surgery on sexual desire in trans persons. AIM: This study aims to explore associations between sex reassignment therapy (SRT) and sexual desire in a large cohort of trans persons. METHODS: A cross-sectional single specialized center study including 214 trans women (male-to-female trans persons) and 138 trans men (female-to-male trans persons). MAIN OUTCOME MEASURES: Questionnaires assessing demographics, medical history, frequency of sexual desire, hypoactive sexual desire disorder (HSDD), and treatment satisfaction. RESULTS: In retrospect, 62.4% of trans women reported a decrease in sexual desire after SRT. Seventy-three percent of trans women never or rarely experienced spontaneous and responsive sexual desire. A third reported associated personal or relational distress resulting in a prevalence of HSDD of 22%. Respondents who had undergone vaginoplasty experienced more spontaneous sexual desire compared with those who planned this surgery but had not yet undergone it (P = 0.03). In retrospect, the majority of trans men (71.0%) reported an increase in sexual desire after SRT. Thirty percent of trans men never or rarely felt sexual desire; 39.7% from time to time, and 30.6% often or always. Five percent of trans men met the criteria for HSDD. Trans men who were less satisfied with the phalloplasty had a higher prevalence of HSDD (P = 0.02). Trans persons who were more satisfied with the hormonal therapy had a lower prevalence of HSDD (P = 0.02). CONCLUSION: HSDD was more prevalent in trans women compared with trans men. The majority of trans women reported a decrease in sexual desire after SRT, whereas the opposite was observed in trans men. Our results show a significant sexual impact of surgical interventions and both hormonal and surgical treatment satisfaction on the sexual desire in trans persons.

Photo-crosslinkable polyester microneedles as sustained drug release systems toward hypertrophic scar treatment.

Burn injuries can result in a significant inflammatory response, often leading to hypertrophic scarring (HTS). Local drug therapies e.g. corticoid injections are advised to treat HTS, although they are invasive, operator-dependent, extremely painful and do not permit extended drug release. Polymer-based microneedle (MN) arrays can offer a viable alternative to standard care, while allowing for direct, painless dermal drug delivery with tailorable drug release profile. In the current study, we synthesized photo-crosslinkable, acrylate-endcapped urethane-based poly(ε-caprolactone) (AUP-PCL) toward the fabrication of MNs. Physico-chemical characterization (1H-NMR, evaluation of swelling, gel fraction) of the developed polymer was performed and confirmed successful acrylation of PCL-diol. Subsequently, AUP-PCL, and commercially available PCL-based microneedle arrays were fabricated for comparative evaluation of the constructs. Hydrocortisone was chosen as model drug. To enhance the drug release efficiency of the MNs, Brij®35, a nonionic surfactant was exploited. The thermal properties of the MNs were evaluated via differential scanning calorimetry. Compression testing of the arrays confirmed that the MNs stay intact upon applying a load of 7 N, which correlates to the standard dermal insertion force of MNs. The drug release profile of the arrays was evaluated, suggesting that the developed PCL arrays can offer efficient drug delivery for up to two days, while the AUP-PCL arrays can provide a release up to three weeks. Finally, the insertion of MN arrays into skin samples was performed, followed by histological analysis demonstrating the AUP-PCL MNs outperforming the PCL arrays upon providing pyramidical-shaped perforations through the epidermal layer of the skin.

AUP-PCL MN arrays provide long-term transdermal drug delivery of hydrocortisoneAUP-PCL-based MN arrays provide superior drug release profiles compared to PCL MNsEffective skin penetration AUP-PCL-based MNs on skin was achieved.

Early Enzymatic Burn Debridement: Results of the DETECT Multicenter Randomized Controlled Trial.

Since 1970 surgeons have managed deep burns by surgical debridement and autografting. We tested the hypothesis that enzymatic debridement with NexoBrid would remove the eschar reducing surgery and achieve comparable long-term outcomes as standard of care (SOC). In this Phase 3 trial, we randomly assigned adults with deep burns (covering 3-30% of total body surface area [TBSA]) to NexoBrid, surgical or nonsurgical SOC, or placebo Gel Vehicle (GV) in a 3:3:1 ratio. The primary endpoint was complete eschar removal (ER) at the end of the debridement phase. Secondary outcomes were need for surgery, time to complete ER, and blood loss. Safety endpoints included wound closure and 12 and 24-months cosmesis on the Modified Vancouver Scar Scale. Patients were randomized to NexoBrid (n = 75), SOC (n = 75), and GV (n = 25). Complete ER was higher in the NexoBrid versus the GV group (93% vs 4%; P < .001). Surgical excision was lower in the NexoBrid vs the SOC group (4% vs 72%; P < .001). Median time to ER was 1.0 and 3.8 days for the NexoBrid and SOC respectively (P < .001). ER blood loss was lower in the NexoBrid than the SOC group (14 ± 512 mL vs 814 ± 1020 mL, respectively; P < .0001). MVSS scores at 12 and 24 months were noninferior in the NexoBrid versus SOC groups (3.7 ± 2.1 vs 5.0 ± 3.1 for the 12 months and 3.04 ± 2.2 vs 3.30 ± 2.76 for the 24 months). NexoBrid resulted in early complete ER in >90% of burn patients, reduced surgery and blood loss. NexoBrid was safe and well tolerated without deleterious effects on wound closure and scarring.