NCT05934851 A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
| NCT ID | NCT05934851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Vulvar Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2023-11-07 |
| Primary Completion | 2026-08-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information. 2. Age ≥ 18 years at the time of consent 3. Histological or cytological confirmation of VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS with a planned excisional procedure, with high suspicion by the enrolling investigator that gross surgical margins of ≥ 3 mm can be achieved without laser or other destructive procedures 4. Surgery is expected to occur within 90 days from randomization 5. Ability to read and understand the English and/or Spanish language 6. As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study 7. No known pregnancy Exclusion Criteria: 1. Excision is not possible due to anatomy (proximity to urethra/clitoris) 2. Known immunodeficiency syndrome 3. Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/imm