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

NARecruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

November 7, 2023

Primary Completion Date

August 1, 2026

Study Completion Date

March 1, 2027

Conditions
Vulvar NeoplasmDysplasia Vulvar
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

Trial Locations (1)

28204

RECRUITING

Levine Cancer Institute, Charlotte

All Listed Sponsors
collaborator

Atrium Health Levine Cancer Institute

OTHER

lead

Wake Forest University Health Sciences

OTHER