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

NCT01741649 | Completed

• 1 other identifier: MHST2012-04
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection

Keywords

Surgical wound infection; Clorhexidine; Povidone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospitalization

  15 days

Study Arms (2)

Clorhexidine

EXPERIMENTAL

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

Procedure: Clorhexidine

Povidone

EXPERIMENTAL

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

Procedure: Povidone

Interventions

Clorhexidine PROCEDURE

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

Clorhexidine

Povidone PROCEDURE

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

Povidone

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age \> 32 weeks
• Emergency cesarean section

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Research

Study Record Dates

• First Submitted: December 1, 2012
• First Posted: December 5, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

PA (1)