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| Sponsor: | Aultman Health Foundation |
|---|---|
| Information provided by: | Aultman Health Foundation |
| ClinicalTrials.gov Identifier: | NCT00550290 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Wound Infection |
Drug: Cefazolin (or Clindamycin in patients with allergy to cephalosporins or PCN) |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy |
| Estimated Enrollment: | 160 |
| Study Start Date: | October 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: No Intervention | |
|
2: Active Comparator
Patients receiving 24 hours of prophylactic antibiotics in the post-operative period following vulvectomy.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Aultman Health Foundation | |
| Canton, Ohio, United States, 44710 | |
| Study Chair: | Michael P Hopkins, MD | Aultman Health Foundation |
| Principal Investigator: | William T. Schnettler, MD | Aultman Health Foundation |
More Information
| Responsible Party: | Aultman Health Foundation ( Michael Hopkins, MD ) |
| Study ID Numbers: | 2007.07.26.E2 |
| Study First Received: | October 25, 2007 |
| Last Updated: | June 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00550290 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
vulvectomy wound infection wound complication prophylactic antibiotic Post-operative wound complications following vulvectomy |
|
Communicable Diseases Cephalosporins Anti-Infective Agents Clindamycin Molecular Mechanisms of Pharmacological Action Clindamycin-2-phosphate Wounds and Injuries Disorders of Environmental Origin Enzyme Inhibitors |
Infection Pharmacologic Actions Protein Synthesis Inhibitors Anti-Bacterial Agents Cefazolin Therapeutic Uses Cefixime Wound Infection |