Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions

The Washington University

Status and phase: Completed; Phase 2

Conditions: Premalignant Vulvar Lesion; Benign Vulvar Lesion

Treatments: Drug: Cefazolin

Study type: Interventional

Funder types: Other

Identifiers

NCT03578965

201804136

Details and patient eligibility

About

A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All women, >=18 undergoing vulvar surgery
• Biopsy proven benign or premalignant lesion requiring surgical management.
• Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
• Scheduled to undergo surgical management for their vulvar disease supervised by a faculty member within the Division of OBGYN at Washington University School of Medicine
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion criteria

• Women who are pregnant
• Women scheduled to undergo a radical vulvectomy
• Women scheduled to undergo a concomitant graft, flap or plastic surgery
• Women <18 years of age
• History of prior vulvar radiation
• Inability to sign an informed consent form prior to registration on study
• Inability to understand spoken or written English
• Prisoner

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Arm A: No antibiotic prophylaxis prior to skin incision

No Intervention group

Description:

-Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.

Arm B: Antibiotic prophylaxis prior to skin incision

Experimental group

Description:

-Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.

Treatment:

Drug: Cefazolin