Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Phase 4

Completed

• Conditions: Wound Infection
• Interventions: Drug: Cefazolin Preoperatively; Drug: Cefazolin PostOperatively

• Registration Number: NCT00550290
• Lead Sponsor: Aultman Health Foundation

Brief Summary

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.

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-26
• Study First Posted: 2007-10-29
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2018-01-29
• Results First Submitted QC: 2018-08-18
• Status Verified: 2018-09
• Results First Posted: 2018-09-18
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefazolin Preoperatively	Cefazolin Preoperatively	Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision
Cefazolin Postoperatively	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

Primary Outcome Measures

Name	Time	Method
Wound Complications	Two-week post-operative	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.

Trial Locations

Locations (1)

Aultman Health Foundation; 🇺🇸 Canton, Ohio, United States