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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03578965
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 40.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Premalignant Vulvar Lesion; Benign Vulvar Lesion	Drug: Cefazolin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The principal investigator along with all members of the study team involved in data analysis as well as the patients will be blinded to the randomization group. The research assistant will disclose the randomization group to the anesthesiologist who will screen the patient for allergies and then obtain the appropriate antibiotics from the pharmacy and administer the antibiotics as appropriate. These will be administered prior to the procedure and so the surgeon will remain blinded to the administration
• Primary Purpose: Prevention
• Official Title: Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
• Actual Study Start Date: Jul 13, 2018
• Actual Primary Completion Date: Nov 23, 2021
• Actual Study Completion Date: Nov 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Antibiotic prophylaxis prior to skin incision -Women randomized to prophylactic antibiotics will receive a cefazolin as per ACOG guidelines.	Drug: Cefazolin; -If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
No Intervention: Arm 1: No antibiotic prophylaxis prior to skin incision -Women randomized to no antibiotic prophylaxis will not receive any antibiotics prior to skin incision.

Outcome Measures

Primary Outcome Measures

1. Vulvar wound complications compared between the two arms [Within 30 days of surgery (estimated to be 30 days)]

   -a) 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 Outcome Measures

1. Clinical risk factors that correlate with vulvar wound complications as measured by demographic variables that predispose patients to infection [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. Clinical risk factors that correlate with vulvar wound complications as measured by vulvar hygiene [Within 30 days of surgery (estimated to be 30 days)]

   Patients will complete the Vulvar Hygiene Survey 2-3 weeks post surgery and the survey is split into two sections - prior to surgery and after surgery. The prior to surgery survey asks 6 questions with yes/no answer choices. The questions ask the patient's doctor if he/she informed them about vulvar hygiene The after surgery section asks 4 questions about if the patient performed specific vulvar hygienic procedures

3. Incidence of adverse events to antibiotic use [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Mary M Mullen, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03578965
• Other Study ID Numbers: 201804136
• First Posted: Jul 6, 2018
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Precancerous Conditions; Cefazolin

Study Results

No Results Posted as of Nov 30, 2021