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Trial record 87 of 256 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition Wound Infection
Interventions Drug: Cefazolin PostOperatively
Drug: Cefazolin Preoperatively
Enrollment 18
Recruitment Details From July, 2007 through December, 2008, all patients undergoing surgical treatment for vulvar cancer at a single tertiary care center were offered enrollment and randomization.
Pre-assignment Details  
Arm/Group Title 24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin.
Hide Arm/Group Description Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
Period Title: Overall Study
Started 10 8
Completed 10 8
Not Completed 0 0
Arm/Group Title 24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin. Total
Hide Arm/Group Description Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin Patients randomized to the standard pre-operative single dosing regimen of Cefazolin. Total of all reporting groups
Overall Number of Baseline Participants 10 8 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
8
 100.0%
18
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
Female
10
 100.0%
8
 100.0%
18
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Wound Complications
Hide Description 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.
Time Frame Two-week post-operative
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received their assigned dose of each intervention and completed all study visits were included in the efficacy analysis.
Arm/Group Title 24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin.
Hide Arm/Group Description:
Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin
Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
Overall Number of Participants Analyzed 10 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  30.0%
2
  25.0%
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin.
Hide Arm/Group Description Patients undergoing surgical treatment for vulvar cancer randomized to an extended 24 hour post-operative course of Cefazolin Patients randomized to the standard pre-operative single dosing regimen of Cefazolin.
All-Cause Mortality
24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
24 Hour Post-operative Course of Cefazolin Pre-operative Single Dose of Cefazolin.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%) 
Small number of subjects recruited lead to unreliable data. A larger sample is needed to answer the research question.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jane Sewell
Organization: Aultman Health Foundation
Phone: 330-363-6793
EMail: Jane.Sewell@aultman.com
Layout table for additonal information
Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT00550290     History of Changes
Other Study ID Numbers: 2007.07.26.E2
First Submitted: October 25, 2007
First Posted: October 29, 2007
Results First Submitted: January 29, 2018
Results First Posted: September 18, 2018
Last Update Posted: October 17, 2018