Official Title: “Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Cefazolin (or Clindamycin in patients with allergy to cephalosporins or PCN)
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
• Active Comparator: 2
  • Patients receiving 24 hours of prophylactic antibiotics in the post-operative period following vulvectomy.

Primary Measures

• Febrile episodes, white blood cell counts, physical exam findings of vulva post-operatively
  • Time Frame: First 2 weeks of post-operative course
    Safety Issue?: No

Secondary Measures

• Evidence of wound infection (fever, leukocytosis, or physical exam findings of infection such as induration, edema, erythema)
  • Time Frame: Within the first 2 post-operative weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Aultman Health Foundation

Overall Clinical Trial Officials and Contacts

Michael P Hopkins, MD Study Chair Aultman Health Foundation  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00550290

Study ID Number: 2007.07.26.E2

ClinicalTrials.gov Identifier: NCT00550290

Health Authority: United States: Institutional Review Board