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

NCT03578965 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201804136
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Premalignant Vulvar Lesion; Benign Vulvar Lesion

Outcome Measures

Primary Outcomes (1)

• Vulvar Wound Complications Compared Between the Two Arms

  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.

  Within 30 days of surgery (estimated to be 30 days)

Secondary Outcomes (3)

• 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)

• Association of Postoperative Vulvar Hygiene Adherence With Vulvar Wound Complications

  Within 30 days of surgery (estimated to be 30 days)

• Incidence of Adverse Events to Antibiotic Use

  Within 30 days of surgery (estimated to be 30 days)

Study Arms (2)

Arm A: No antibiotic prophylaxis prior to skin incision

NO INTERVENTION

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

Arm B: Antibiotic prophylaxis prior to skin incision

EXPERIMENTAL

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

Drug: Cefazolin

Interventions

Cefazolin DRUG

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

Arm B: Antibiotic prophylaxis prior to skin incision

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Mary M. Mullen, M.D.
• Organization: Washington University School of Medicine

marymullen@wustl.edu

314-655-8750

Study Officials

• Mary M Mullen, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: July 13, 2018
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: November 21, 2022
• Results First Posted: November 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)