Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy - Full Text View

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Fever

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Cefazolin Cefazolin sodium Clindamycin palmitate

U.S. FDA Resources

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
No Intervention: 1
Active Comparator: 2 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:	Michael Hopkins, MD, Aultman Health Foundation
ClinicalTrials.gov Identifier:	NCT00550290 History of Changes
Other Study ID Numbers:	2007.07.26.E2
Study First Received:	October 25, 2007
Last Updated:	June 24, 2009
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:

Wound Infection
Infection
Wounds and Injuries
Anti-Bacterial Agents
Cefazolin
Clindamycin
Clindamycin-2-phosphate

Cephalosporins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012