Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
|ClinicalTrials.gov Identifier: NCT01741649|
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : May 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Infection||Procedure: Clorhexidine Procedure: Povidone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.
Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.
Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.
- 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".
- 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".
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741649
|Saint Thomas Maternity Hospital|