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Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00550290
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : September 18, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Aultman Health Foundation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Wound Infection Drug: Cefazolin PostOperatively Drug: Cefazolin Preoperatively Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Study Start Date : October 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cefazolin Preoperatively
Participants received Cefazolin 2 grams intravenously within 30 minutes prior to incision
 Drug: Cefazolin Preoperatively
Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.
Other Names:
  • Ancef
  • Kefzol
Experimental: Cefazolin Postoperatively
Participants received Cefazolin 2 gram intravenous within 30 minutes prior to incision and 1 gram Cefazolin every 8 hours for the first 24 hours post-op
 Drug: Cefazolin PostOperatively
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.
Other Names:
  • Ancef
  • Kefzol


Outcome Measures
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Primary Outcome Measures :
  1. Wound Complications [ Time Frame: Two-week post-operative ]
    Number of participants experiencing wound complications following vulvectomy. The presence of febrile episodes, elevated WBC counts and exam findings will be used to diagnose wound complications.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550290


Locations
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United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
Investigators
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Study Chair: Michael P Hopkins, MD Aultman Health Foundation
Principal Investigator: William T. Schnettler, MD Aultman Health Foundation
More Information
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Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT00550290    
Other Study ID Numbers: 2007.07.26.E2
First Posted: October 29, 2007    Key Record Dates
Results First Posted: September 18, 2018
Last Update Posted: October 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Aultman Health Foundation:
vulvectomy
wound infection
wound complication
prophylactic antibiotic
Post-operative wound complications following vulvectomy
Additional relevant MeSH terms:
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Wound Infection
Wounds and Injuries
Infections
 Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents