This phase II trial studies how well antibiotic prophylaxis before surgery works in reducing wound complications after vulvar excision in patients with vulvar disease. Antibiotics administered prior to surgery may help to decrease the risk of wound complications.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03578965.
PRIMARY OBJECTIVE:
I. Evaluate for the difference in wound complications between women who receive antibiotic prophylaxis and those who do not.
SECONDARY OBJECTIVES:
I. Determine the clinical risk factors that correlate with vulvar wound complications.
Ia. Record steroid use or the use of other immunosuppressive medications.
Ib. Evaluation of vulvar hygiene through physician and patient survey.
Ic. Incidence of adverse events to antibiotic use.
TERTIARY OBJECTIVES:
I. Evaluate for differences in the following outcomes between women who receive antibiotic prophylaxis and those who do not:
Ia. Inpatient re-admission for postoperative wound care within 30 days of surgery.
Ib. Antibiotic safety measures including allergic reaction type and severity.
OUTLINE: Patients are randomized into 1 of 2 arms.
ARM I: Patients receive cefazolin sodium or clindamycin before standard of care vulvar surgery.
ARM II: Patients undergo standard of care vulvar surgery.
After completion of study treatment patients are followed up within 7-30 days.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorMary Margaret Mullen
