Prevention of Surgical Site Infection After Cesarean Delivery (CAPISSI)

January 11, 2016 updated by: Arvind Palanisamy, MD, FRCA, Brigham and Women's Hospital

Chlorhexidine-Alcohol Vs. Povidone-Iodine for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Trial

There are approximately 1.4 million cesarean deliveries in the United States each year, and an average of 1250 elective cesarean deliveries each year at the Brigham and Women's Hospital (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH, approximately 2% of patients are diagnosed with a surgical site infection (SSI). Because SSI is associated with significant morbidity and increased cost of care, numerous guidelines exist to guide preoperative administration of prophylactic antibiotics. However, there are no recommendations for the choice of antiseptic solution for prevention of SSI. Among the currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery. Many institutions use povidone-iodine, another antisepsis preparation that does not require the mandatory drying time. Our randomized study aims to compare the incidence of SSI in patients receiving either CA or PI during elective cesarean delivery, and we hypothesize that CA would be associated with a lower incidence of SSI.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted over three years with an estimated sample size of 4500 patients. Prior to enrollment of study subjects, each year will be divided into 3-month blocks and each block will be assigned one of the two study antiseptic solutions - 2% chlorhexidine gluconate in 70% isopropyl alcohol (CA) or 10% Povidone-Iodine (PI) - in an alternating manner. All patients undergoing elective cesarean deliveries during a block will receive the same preoperative skin preparation, in concordance with guidelines for its use. The block assignments will alternate within each year and the order will be reversed after one year to minimize or eliminate seasonal variation in skin infection rates. All patients will receive routine history and physical examination, blood tests, pre-procedure bathing instructions, and preoperative body hair clipping as desired by their primary obstetric provider. Age, body mass index (BMI), gestational age, history of smoking, previous abdominal surgery, number of pregnancies, and live births will be documented before entry into the study. Eligible patients will receive antibiotic prophylaxis with weight-based cefazolin within 60 min before skin incision. We will collect data on preoperative preparation of the surgical site (clipping vs. shaving), type of skin and uterine incision, method of fascia and skin closure, duration of the procedure, use of postoperative antibiotics, and adverse reactions to the skin preparation. The primary endpoint for this study will be any SSI diagnosed within 30 days of cesarean delivery. Our secondary outcomes will be the type of SSI (based on the Center for Disease Control infection classification) and the time to diagnosis of SSI.

The Infectious Disease department at BWH will perform the surveillance for SSI/endometritis. This team will be blinded to the choice of anti-sepsis preparation during the study period. Briefly, surveillance will include daily, weekly, monthly, and quarterly reviews of data. The infectious disease team will perform a daily review of microbiology results for positive wound and blood cultures, and assess whether the patient had cesarean section within 30 days prior to cultures. On a weekly basis, a report of obstetric patients readmitted within 30 days will be generated, and patients will be selected with an admitting diagnosis consistent with infection in the setting of a history of recent cesarean delivery. Each month, a report of patients will be generated with ICD-9 discharge code for cesarean section as well as ICD-9 codes for other complications of obstetrical surgical wound and major puerperal infection. Post-cesarean delivery patients receiving antibiotics for at least 2 days after the first postoperative day, and those that receive antibiotics during readmission will also be identified and recorded. During every quarter, the number of elective cesarean deliveries performed will be quantified, and the incidence of specific sub-types of SSI (superficial, deep, organ space/endometritis) will be documented. In addition to inpatient surveillance, the electronic clinic records for all patients will be reviewed, and data will be recorded for any SSI that is diagnosed and treated on an outpatient basis. Documentation from discharge to the six-week postpartum visit will be reviewed to ensure data fidelity, but only infections that occur within 30 days of cesarean delivery will be included in the final analyses. Active SSI will be treated according to prevailing guidelines.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients scheduled for elective cesarean delivery

Exclusion Criteria:

  • Allergy to either of the antiseptic preparations
  • Ongoing active skin or systemic infection
  • Pre-operative antibiotic therapy for non-surgical reasons
  • Those unable to receive antibiotic prophylaxis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorhexidine-alcohol group
2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.
Drug: Chlorhexidine-alcohol group
2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.
Other Names:
  • Chloraprep
Experimental: Povidone-Iodine group
10% Povidone-iodine applied topically according to manufacturer's instructions
Drug: Povidone-Iodine Group
10% Povidone-Iodine for surgical antisepsis according to manufacturer's instructions.
Other Names:
  • Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Surgical Site Infection within 30 days of Cesarean Delivery
Time Frame: At 3 years after first patient enrollment
At 3 years after first patient enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Type of SSI (based on CDC classification)
Time Frame: 3 years after initial enrollment
3 years after initial enrollment
Time to diagnosis of SSI
Time Frame: 3 years after initial enrollment
3 years after initial enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Arvind Palanisamy, MD, FRCA, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P002037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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