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

Sponsor

Saint Thomas Hospital, Panama (Other)

Overall Status

Completed

CT.gov ID

NCT01741649

Collaborator

(none)

800

Enrollment

Location

Arms

Duration (Months)

133.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection	Procedure: Clorhexidine Procedure: Povidone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clorhexidine Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.	Procedure: Clorhexidine Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
Experimental: Povidone Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.	Procedure: Povidone Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.

Arm

Intervention/Treatment

Experimental: Clorhexidine

Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.

Procedure: Clorhexidine

Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.

Experimental: Povidone

Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.

Procedure: Povidone

Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.

Outcome Measures

Primary Outcome Measures

Surgical Site infection (SSI) [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".

Secondary Outcome Measures

Hospitalization [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.