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| Name | Class |
|---|---|
| Kerecis Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals receiving vaginoplasty | Individuals requiring graft-based vaginoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Six months post-op |
| 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). | Post-op week 2, week, 12, month 6, and year 1 |
| 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). | Post-op week 2, week, 12, month 6, and year 1 |
| 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. | Week 2, Week 12, Month 6, and year 1 post-op |
| Change in Pain as measured by the Brief Pain Inventory - Short Form (BPI-SF) | This is a concise validated questionnaire used to evaluate the severity and impact of pain experienced by individuals. It consists of questions that assess the intensity of pain at its worst, least, average, and current levels, as well as its interference with various aspects of daily life such as general activity, mood, walking ability, work, relationships, and enjoyment of life. Higher scores indicate worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
Participants are only eligible if assigned sex at birth is male, and diagnosed with gender dysphoria.
Individuals requiring graft-based vaginoplasty
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyed Sajjad Tabei, MD | Contact | 216-844-8963 | seyedsajjad.tabei@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Shubham Gupta, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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|
| Biopsy | Procedure | Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina. |
|
| Week 2, Week 12, Month 6, and year 1 post-op |
| Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI) | This is a validated questionnaire used to assess symptoms related to genitourinary pain in women. It includes questions covering pain severity, urinary symptoms, and impact on quality of life, providing clinicians with a standardized tool to evaluate and monitor participants' symptoms and treatment responses in these chronic pain conditions. Higher scores indicate worse outcomes. | Week 2, Week 12, Month 6, and year 1 post-op |
| Change in overall perception of improvement as measured by the PGI-I (Patient Global Impression of Improvement) | This is a patient-reported scale that measures how individuals perceive their overall improvement after treatment, offering clinicians insight into treatment effectiveness from the participant's viewpoint. Lower scores indicate better outcomes. | Week 2, Week 12, Month 6, and year 1 post-op |
| Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI) | This is a validated 19-item questionnaire assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored, and the total score reflects overall sexual function, with higher scores indicating better function. It is used in clinical and research settings to evaluate sexual health and the impact of treatments. Higher scores indicate better outcomes. | Month 6, and year 1 post-op |
| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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