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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Procedure: Clorhexidine
* Procedure: Povidone


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical wound infection, Clorhexidine, Povidone