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RecruitingNot ApplicableNCT05934851

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

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

Sponsor

Wake Forest University Health Sciences

Enrollment

112 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

Vulvar NeoplasmDysplasia Vulvar

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age ≥ 18 years at the time of consent
  • 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
  • Surgery is expected to occur within 90 days from randomization
  • Ability to read and understand the English and/or Spanish language
  • As determined by the enrolling physician, ability and willingness of the subject to comply with study procedures for the entire length of the study
  • No known pregnancy

Exclusion Criteria5

  • Excision is not possible due to anatomy (proximity to urethra/clitoris)
  • Known immunodeficiency syndrome
  • Immunosuppressant medications taken within the last 30 days (HIV, organ transplant recipient, chronic steroid use/immunosuppressant)
  • History of pelvic region radiation therapy
  • Active anticancer treatment

Interventions

PROCEDUREFrozen-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.

PROCEDUREWide 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

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NCT05934851