Gender Affirming Robotic Vaginoplasty Using Fish Skin Graft Kerecis17 with Tubularized Augmented Peritoneal Cap TAPCap Technique for Transgender Women

What this Trial Is About

This research focuses on transgender women undergoing bottom gender affirming surgery, specifically robotic vaginoplasty using a Tubularized Augmented Peritoneal Cap TAPCap technique. The study aims to assess healing changes after using a special graft called Kerecis, made from treated North Atlantic cod skin, which lines the middle part of the newly constructed vagina. The trial seeks to evaluate how this graft affects healing and quality of life in up to 20 participants. The surgery involves creating the distal part of the neovagina from inverted penile skin, the proximal part from peritoneal tissue, and lining the area in between with the Kerecis graft. Biopsies will be taken six months after surgery from different parts of the neovagina to examine healing under a microscope. Participants will be followed up with questionnaires at 2 weeks, 12 weeks, 6 months, and 1 year post-operation to measure healing, vaginal dimensions, pain, quality of life, and sexual function. Participants will complete several assessments including the Short-Form 36 for quality of life, Brief Pain Inventory, Female Genitourinary Pain Index, Patient Global Impression of Improvement, and Female Sexual Function Index. The study will monitor changes in vaginal epithelialization, diameter, and depth at various postoperative points. The total participation lasts up to one year with detailed follow-up visits and biopsies to observe healing progress and patient-reported outcomes.

Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)