Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Aultman Health Foundation

Status and phase: Completed; Phase 4

Conditions: Wound Infection

Treatments: Drug: Cefazolin PostOperatively; Drug: Cefazolin Preoperatively

Study type: Interventional

Funder types: Other

Identifiers

NCT00550290

2007.07.26.E2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Cefazolin Preoperatively

Active Comparator group

Description:

Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision

Treatment:

Drug: Cefazolin Preoperatively

Cefazolin Postoperatively

Experimental group

Description:

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

Treatment:

Drug: Cefazolin PostOperatively