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Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section

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: NCT01741649
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
First Submitted Date  ICMJE December 1, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date May 17, 2013
Study Start Date  ICMJE October 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Surgical Site infection (SSI) [ Time Frame: 3 days ]
The patients will be evaluated for evidence of surgical site infection before leaving the hospital, three (3) days after surgery. The presence of fever, suppurative secretion through the wound or cutaneous changes compatible witn infection will be considered a surgical site infection (SSI). This outcome will be evaluated with a qualitative variable (presence of SSI). The patients will be classified in accordance as "With SSI" or "Without SSI".
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01741649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Hospitalization [ Time Frame: 15 days ]
The patients will be evaluated for evidence of surgical site infection 15 days post surgery. The need to admit the patient to the hospital for management of a surgical site infection will be classified with "Hospitalization - Yes/No".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
Official Title  ICMJE Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
Brief Summary Many solutions are used for cleaning the skin of a patient previous to a surgery. Although the efficacy of clorhexidine has been proved in other surgical procedures, there is only a retrospective study in cesarean section (they report no benefit of one solution over the other). The investigators would like to evaluate the difference in surgical site infection in patients after cesarean section comparing preparation of the skin with clorhexidine versus povidone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Surgical Wound Infection
Intervention  ICMJE
  • Procedure: Clorhexidine
    Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
  • Procedure: Povidone
    Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.
Study Arms  ICMJE
  • Experimental: Clorhexidine
    Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.
    Intervention: Procedure: Clorhexidine
  • Experimental: Povidone
    Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.
    Intervention: Procedure: Povidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2013)
800
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
880
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gestational age > 32 weeks
  • Emergency cesarean section

Exclusion Criteria:

  • Allergy to clorhexidine
  • Allergy to povidone
  • Evidence of infection in the surgical site
  • Loss to follow up at 15 days
  • Surgeries that due to the emergency of the case do not allow the five minutes of skin cleaning.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741649
Other Study ID Numbers  ICMJE MHST2012-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor  ICMJE Saint Thomas Hospital, Panama
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Saint Thomas Hospital, Panama
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP