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

Conditions

• Gender Dysphoria, Adult

Eligibility Criteria

Sex

MALE

Age

19 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Tubularized augmented peritoneal cap vaginoplasty — PROCEDURE
  In 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
  Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.

Study Details

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.

Key Dates

Start date

Jul 22, 2025

Status verified

Dec 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

20 participants (estimated)

Arms

• Arm: Individuals receiving vaginoplasty
  Individuals requiring graft-based vaginoplasty

Primary Outcome Measure

Degree of Neovaginal Epithelialization [ Time Frame: Six months post-op ]

Central Contacts

• Seyed Sajjad Tabei, MD
  216-844-8963
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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