Purpose

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.

Condition

Eligibility

Eligible Ages
Between 19 Years and 99 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Individuals receiving vaginoplasty Individuals requiring graft-based vaginoplasty
  • Procedure: 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.
  • Procedure: Biopsy
    Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.

Recruiting Locations

University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Seyed Sajjad Tabei, MD
216-844-8963
seyedsajjad.tabei@uhhospitals.org

More Details

Status
Recruiting
Sponsor
University Hospitals Cleveland Medical Center

Study Contact

Seyed Sajjad Tabei, MD
216-844-8963
seyedsajjad.tabei@uhhospitals.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.