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 Details — Status: Completed

Administrative data

• NCT number: NCT00550290
• Other study ID #: 2007.07.26.E2
• Status: Completed
• Phase: Phase 4
• Start date: October 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2018
• Source: Aultman Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Infection
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Aultman Health Foundation	Canton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Aultman Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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