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RECRUITING
NCT05934851
NA

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

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

Official title: A Prospective, Randomized, Single-blinded Study Evaluating the Effect of Frozen-Section Directed Excision on Positive Surgical Margins in High-grade Vulvar Dysplasia

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2023-11-07

Completion Date

2027-03-01

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

PROCEDURE

Frozen-Section Directed 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.

PROCEDURE

Wide Local Excision

Standard of care surgical technique utilized for VIN 2, VIN3, VIN 2/3 or High-grade Dysplasia NOS

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States