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

• Status: Completed
• Trial end date: 2021-09-19
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin

Criteria

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