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NCT Number: NCT01741649

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

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clorhexidine

Procedure

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

Povidone

Procedure

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

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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