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

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Procedure: Povidone; Procedure: Clorhexidine

• Registration Number: NCT01741649
• Lead Sponsor: Saint Thomas Hospital, Panama

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 available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-01
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 800

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Povidone	Povidone	Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.
Clorhexidine	Clorhexidine	Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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".

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama