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Sponsored by: |
Aultman Health Foundation |
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Information provided by: | Aultman Health Foundation |
ClinicalTrials.gov Identifier: | NCT00550290 |
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 |
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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 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention | |
2: Active Comparator
Patients receiving 24 hours of prophylactic antibiotics in the post-operative period following vulvectomy.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: William T Schnettler, MD | 330-363-6214 | wscnettler@aultman.com |
Contact: Michael P Hopkins, MD | 330-363-6214 | mhopkins@aultman.com |
United States, Ohio | |
Aultman Health Foundation | Recruiting |
Canton, Ohio, United States, 44710 | |
Contact: William T Scnettler, MD 330-363-6214 wschnettler@aultman.com | |
Contact: Michael P Hopkins, MD 330-363-6214 mhopkins@aultman.com | |
Principal Investigator: William T Schnettler, MD |
Study Chair: | Michael P Hopkins, MD | Aultman Health Foundation |
Principal Investigator: | William T. Schnettler, MD | Aultman Health Foundation |
Responsible Party: | Aultman Health Foundation ( Michael Hopkins, MD ) |
Study ID Numbers: | 2007.07.26.E2 |
Study First Received: | October 25, 2007 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00550290 |
Health Authority: | United States: Institutional Review Board |
vulvectomy wound infection wound complication prophylactic antibiotic Post-operative wound complications following vulvectomy |
Cephalosporins Clindamycin Cefazolin Clindamycin-2-phosphate |
Cefixime Wounds and Injuries Disorders of Environmental Origin Wound Infection |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |