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Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
This study has been completed.
First Received: October 25, 2007   Last Updated: June 24, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Aultman Health Foundation:

Primary Outcome Measures:
  • Febrile episodes, white blood cell counts, physical exam findings of vulva post-operatively [ Time Frame: First 2 weeks of post-operative course ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550290

Locations
United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
Investigators
Study Chair: Michael P Hopkins, MD Aultman Health Foundation
Principal Investigator: William T. Schnettler, MD Aultman Health Foundation
  More Information

No publications provided

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

Keywords provided by Aultman Health Foundation:
vulvectomy
wound infection
wound complication
prophylactic antibiotic
Post-operative wound complications following vulvectomy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010