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

University Hospitals (UH)

Status: Enrolling

Conditions: Gender Dysphoria, Adult

Treatments: Procedure: Biopsy; Procedure: Tubularized augmented peritoneal cap vaginoplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07286123

STUDY20250076

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 19-99
• Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique

Exclusion criteria

• 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
• Allergy to fish products
• Allergy to local anesthetic (1% lidocaine with epinephrine injection)

Trial design

20 participants in 1 patient group

Individuals receiving vaginoplasty

Description:

Individuals requiring graft-based vaginoplasty

Treatment:

Procedure: Tubularized augmented peritoneal cap vaginoplasty

Procedure: Biopsy