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

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Procedure: Clorhexidine; Procedure: Povidone

Study type: Interventional

Funder types: Other

Identifiers

NCT01741649

MHST2012-04

Details and patient eligibility

About

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.

Enrollment: 800 patients

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Clorhexidine

Experimental group

Description:

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

Treatment:

Procedure: Clorhexidine

Povidone

Experimental group

Description:

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

Treatment:

Procedure: Povidone