An interventional study of Frozen-Section Directed Excision and Wide Local Excision in Vulvar Neoplasm and Dysplasia Vulvar, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
This is a randomized, single-blinded study. The target population is adults ≥ 18 years of age with 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. One group of subjects will be assigned to the Frozen-Section Directed Excision surgery arm and will undergo this procedure. The other group of subjects will be assigned to the Wide Local Excision (standard of care) arm and will undergo this procedure. The randomization will be 1:1, meaning for every subject who gets assigned to the Frozen-Section Directed Excision surgery arm, one will also be assigned to the Wide Local Excision arm. There is a 50% chance of getting randomized to either the Frozen-Section Directed Excision procedure or Wide Local Excision. Information regarding the surgery procedure, the amount of time the surgery procedure takes, and total amount of pain medication required during surgery and while in the surgery recovery area will be collected. The study team will also look at recurrence rates (return of the cancer) in six months, if any other therapies are required, and subject satisfaction related to the surgery, recovery, and sexual function by using questionnaires before and after the procedure.
210 studies on the registry are indexed under Vulvar Neoplasms; 71 are open to participants now.
This study's planned enrollment of 112 is above the median of 55 across 151 interventional studies indexed under Vulvar Neoplasms.
Browse Vulvar Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The surgeon(s) will identify the lesion and make a 1 mm excision around the lesion site.
Procedure: Frozen-Section Directed Excision
The surgeon(s) will visually identify the abnormal lesion. A Wide Local Excision with 5 mm margins will be made through the dermis per standard of care.
Procedure: Wide Local Excision
Frozen-Section Directed Excision (FSDE) is a surgical technique with evaluation of margin status during the surgical procedure, similar to the established Mohs Surgical Technique. The use of FSDE may ensure negative margins, decrease unnecessary excision of healthy tissue and has the potential to greatly reduce positive margins.
Also known as: FSDE
Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade Dysplasia NOS
Rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS
Comparison of rates of positive margins for VIN 2, VIN 3, VIN 2/3 or High-grade Dysplasia NOS in subjects who undergo standard of care Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: At the time of the resection
Recurrence rates at 6 months
Comparison of recurrence rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: 6 months post resection surgery
Surgical time
Comparison of surgical time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: At the time of the resection
Recovery room time
Comparison of recovery room time in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: At the time of the resection and recovery
Narcotic dose required (total during surgery and in recovery)
Comparison of narcotic dose required in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: At the time of the resection and recovery
Blood loss
Comparison of blood loss in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: At the time of the resection
Primary wound closure rates
Comparison of primary wound closure rates in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: 2-week post resection surgery
Post-operative quality of life as determined by the SSQ-8
Comparison of post-operative quality of life as determined by the SSQ-8 in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: 2-weeks and 6 months after resection surgery
Sexual function as determined by the FSFI
Comparison of sexual function as determined by the FSFI in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: Screening and 6 months after resection surgery
Wound bed size after surgery
Comparison of wound bed size after surgery in subjects who undergo standard Wide Local Excision versus subjects who undergo Frozen-Section Directed Excision
Time frame: End of resection surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences