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 19-99
Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique
Patients requiring Kerecis for Revision Vaginoplasty
Surgery candidates having Zero depth vaginoplaty (ZDV)
Non-Gender Affirming Vaginoplasty
Cases requiring the utilization of off-the-shelf grafts other than Kerecis
Individuals requiring graft-based vaginoplasty
Cohort
Prospective
Tubularized augmented peritoneal cap vaginoplasty
Procedure/SurgeryIn this surgery, the distal portion of the neovagina is constructed using inverted penile skin, the proximal portion is made of peritoneal tissue. The area in between peritoneal tissue and penile skin is lined with the Kerecis graft in this standard of care surgery.
Biopsy
Procedure/SurgeryBiopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.
Degree of Neovaginal Epithelialization
Degree of epithelialization of each sample biopsy. Biopsies are obtained from the proximal segment (peritoneal portion), middle segment (Xenograft portion), and, distal segment (penile skin portion) of the neovagina. Grade 0: No epithelialization Grade 1 : Minimal epithelialization Grade 2: Moderate epithelialization Grade 3: Significant epithelialization
Change in Vaginal Diameter
The participants' vaginal diameter is calculated based on the largest tolerated vaginal dilator size (Soul Source; CA, USA) . Measurements are reported in centimeters (cm).
Change in Vaginal Depth
The participants' vaginal depth are calculated based on the largest tolerated vaginal dilator (Soul Source, CA, USA). Measurements are reported in centimeters (cm).
Change in quality of life as measured by the Short-Form 36 (SF-36)
This is a validated questionnaire measuring health-related quality of life through eight domains, covering physical and mental well-being. It's widely used in healthcare to assess overall health perception and functional status. With higher scores indicating greater quality of life.
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University Hospitals Cleveland Medical Center
Lead sponsor
Kerecis Ltd.
Collaborator
