NCT00550290

Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Aultman Health Foundation · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Infection

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-10-29
• Last updated: 2018-10-17
• Results posted: 2018-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study