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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741649
• Other study ID #: MHST2012-04
• Status: Completed
• Phase: N/A
• First received: December 1, 2012
• Last updated: May 16, 2013
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• Clorhexidine
Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
• Povidone
Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No