Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

Study Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Drug: Cefazolin Preoperatively; Drug: Cefazolin PostOperatively

Detailed Description

Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. Included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. Specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complication is as high as 58%. Surgery is the treatment of choice for vulvar cancer, but few studies establish protocols or management strategies to prevent the complications of post-operative wound infection and breakdown. This proposed randomized prospective study would specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy. This same regimen has been described by a leader in the field of gynecology in his text - TeLinde's Operative Gynecology. This study will utilize two arms - one as the treatment arm utilizing 24 hours of prophylactic antibiotics and the other as control.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Health Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All female patients 18 years of age or older undergoing surgery for vulvar carcinoma (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy without groin node dissection, and partial vulvectomy)
• Disease State will not affect inclusion in the study. Women with previous surgery for vulvar carcinoma will be included as will those undergoing initial operation.
• Number of subjects: 160

Exclusion Criteria:

• Women simultaneously undergoing treatment for other forms of cancer
• Women under the age of 18
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cefazolin Preoperatively; Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision	Drug: Cefazolin Preoperatively; Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.; Other Names: Ancef; Kefzol
Experimental: Cefazolin Postoperatively; Participants received Cefazolin 2 gram intravenous within 30 minutes prior to incision and 1 gram Cefazolin every 8 hours for the first 24 hours post-op	Drug: Cefazolin PostOperatively; Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.; Other Names: Ancef; Kefzol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Complications	Number of participants experiencing wound complications following vulvectomy. The presence of febrile episodes, elevated WBC counts and exam findings will be used to diagnose wound complications.	Two-week post-operative

Collaborators and Investigators

• Sponsor: Aultman Health Foundation
• Investigators: Study Chair: Michael P Hopkins, MD, Aultman Health Foundation; Principal Investigator: William T. Schnettler, MD, Aultman Health Foundation

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: October 25, 2007
• First Submitted That Met QC Criteria: October 26, 2007
• First Posted (Estimate): October 29, 2007

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: wound infection; wound complication; prophylactic antibiotic; vulvectomy; Post-operative wound complications following vulvectomy
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: 2007.07.26.E2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes