Bottom gender affirming surgery is one of the key steps towards aligning the physical appearance and gender identity in transgender women. This surgery not only helps in reducing gender dysphoria but also significantly improves the quality of life and psychological well-being of the patients. The basic steps of bottom surgery typically involve the creation of a vagina using the skin from genital organs like the testes and penis, construction of the clitoris and labia. This complex surgery aims to create a functional and aesthetically pleasing vaginal canal that allows for sexual activity, urinary function, and a natural appearance. As part of routine care, a special graft (skin-like material) called Kerecis™ is used to line the middle part of the vagina. It is made from North Atlantic cod skin that is treated in the laboratory and made suitable for surgery purposes. It can be used instead of skin. This graft has been given permission by the Food and Drug Administration (FDA) for marketing the US. This study aims to identify changes in healing parameters following Kerecis™ based vaginoplasty. Up to 20 participants for this study. Participants will be asked to fill out study questionnaires during follow-up visits at post-op week 2, week 12, month , and year 1. At the 6 month post-op follow up, punch biopsies will be obtained from the deepest part, middle part, and the vaginal part most near to the vaginal opening parts to check the healing process using a microscope. The punch biopsies will be 1/8th inch x 1/8th inch each.
Age range
19 Years – 99 Years
Sex
MALE
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Degree of Neovaginal Epithelialization
Timeframe: Six months post-op
Change in Vaginal Diameter
Timeframe: Post-op week 2, week, 12, month 6, and year 1
Change in Vaginal Depth
Timeframe: Post-op week 2, week, 12, month 6, and year 1
Change in quality of life as measured by the Short-Form 36 (SF-36)
Timeframe: Week 2, Week 12, Month 6, and year 1 post-op
Change in Pain as measured by the Brief Pain Inventory - Short Form (BPI-SF)
Timeframe: Week 2, Week 12, Month 6, and year 1 post-op
Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI)
Timeframe: Week 2, Week 12, Month 6, and year 1 post-op
Change in overall perception of improvement as measured by the PGI-I (Patient Global Impression of Improvement)
Timeframe: Week 2, Week 12, Month 6, and year 1 post-op
Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI)
Timeframe: Month 6, and year 1 post-op