A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia

Eligibility 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
• 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/immunosuppressant)
• 4. History of pelvic region radiation therapy
• 5. Active anticancer treatment