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OpenTrials
Completed

NCT Number: NCT03578965

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

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.

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Key information

Conditions

Premalignant Vulvar Lesion Benign Vulvar Lesion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision

Primary outcomes

  1. Vulvar Wound Complications Compared Between the Two Arms

    Time frame: Within 30 days of surgery (estimated to be 30 days)

    Wound complication will be defined as a composite outcome that includes wound breakdown, sterile site infection, hematoma, seroma diagnosed within 30 days after excision. Sterile Site Infection (SSI) - defined as purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.

Secondary outcomes

  1. Clinical Risk Factors That Correlate With Vulvar Wound Complications as Measured by Demographic Variables That Predispose Patients to Infection

    Time frame: Within 30 days of surgery (estimated to be 30 days)

    Clinical risk factors could include history of diabetes, liver disease, human immunodeficiency virus, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, peripheral vasculature disease, dementia, connective tissues disease, leukemia, lymphoma, peptic ulcer disease, hypertension, steroid use, and use of other immunosuppressive medications.

  2. Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications

    Time frame: Within 30 days of surgery (estimated to be 30 days)

    • Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery.
    • The after surgery section asks 6 questions about if the patient performed specific vulvar hygienic procedures

  3. Incidence of Adverse Events to Antibiotic Use

    Time frame: Within 30 days of surgery (estimated to be 30 days)

    -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2018
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.