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Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Wound Infection Clinical Trial

Official title:
Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00550290
Study type Interventional
Source Aultman Health Foundation
Contact
Status Completed
Phase Phase 4
Start date October 2007
Completion date April 2009
View Details
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