Back to resultsClorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Clorhexidine
Povidone
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Surgical wound infection, Clorhexidine, Povidone
Eligibility Criteria
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.
Sites / Locations
- Saint Thomas Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Clorhexidine
Povidone
Arm Description
Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.
Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.
Outcomes
Primary Outcome Measures
Surgical Site infection (SSI)
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".
Secondary Outcome Measures
Hospitalization
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".
Full Information
NCT ID
NCT01741649
First Posted
December 1, 2012
Last Updated
May 16, 2013
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT01741649
Brief Title
Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
Official Title
Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Surgical wound infection, Clorhexidine, Povidone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clorhexidine
Arm Type
Experimental
Arm Description
Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.
Arm Title
Povidone
Arm Type
Experimental
Arm Description
Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.
Intervention Type
Procedure
Intervention Name(s)
Clorhexidine
Intervention Description
Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
Intervention Type
Procedure
Intervention Name(s)
Povidone
Intervention Description
Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.
Primary Outcome Measure Information:
Title
Surgical Site infection (SSI)
Description
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".
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Hospitalization
Description
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".
Time Frame
15 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section
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