Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
NCT ID: NCT07286123
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-07-22
2027-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Individuals receiving vaginoplasty
Individuals requiring graft-based vaginoplasty
Tubularized augmented peritoneal cap vaginoplasty
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
Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.
Interventions
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Tubularized augmented peritoneal cap vaginoplasty
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
Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.
Eligibility Criteria
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Inclusion Criteria
* Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique
Exclusion Criteria
* 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)
19 Years
99 Years
MALE
No
Sponsors
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Kerecis Ltd.
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Shubham Gupta
Professor
Principal Investigators
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Shubham Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20250076
Identifier Type: -
Identifier Source: org_study_id