Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
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|ClinicalTrials.gov Identifier: NCT00550290|
Recruitment Status : Completed
First Posted : October 29, 2007
Results First Posted : September 18, 2018
Last Update Posted : October 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Wound Infection||Drug: Cefazolin PostOperatively Drug: Cefazolin Preoperatively||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
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.
- 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.
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
|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|