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A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia
Sponsor: Wake Forest University Health Sciences
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
Conditions
Interventions
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.
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