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Trial record 37 of 280 for:    Panama

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

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ClinicalTrials.gov Identifier: NCT01741649
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Procedure: Clorhexidine Procedure: Povidone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection in Patients After Cesarean Section. Randomized, Controlled Trial.
Study Start Date : October 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Povidone

Arm Intervention/treatment
Experimental: Clorhexidine
Skin prior to the surgical incision will be cleaned for five minutes with Clorhexidine.
Procedure: Clorhexidine
Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.

Experimental: Povidone
Skin prior to surgical incision will be cleaned for five minutes with a povidine solution.
Procedure: Povidone
Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.




Primary Outcome Measures :
  1. Surgical Site infection (SSI) [ Time Frame: 3 days ]
    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".


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 15 days ]
    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".



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741649


Locations
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Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama

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Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01741649     History of Changes
Other Study ID Numbers: MHST2012-04
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Surgical wound infection
Clorhexidine
Povidone
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Povidone
Plasma Substitutes
Blood Substitutes