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

NCT ID: NCT01741649

Last Updated: 2013-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clorhexidine

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

Group Type EXPERIMENTAL

Clorhexidine

Intervention Type PROCEDURE

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

Povidone

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

Group Type EXPERIMENTAL

Povidone

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clorhexidine

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

Intervention Type PROCEDURE

Povidone

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Osvaldo A. Reyes T.

Coordinator of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Panama

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MHST2012-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.