Prevention of Surgical Site Infection After Cesarean Delivery

NCT ID: NCT02027324

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-02-28

Brief Summary

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.

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.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Chlorhexidine-alcohol group

2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.

Group Type: EXPERIMENTAL

Chlorhexidine-alcohol group

Intervention Type: DRUG

2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.

Povidone-Iodine group

10% Povidone-iodine applied topically according to manufacturer's instructions

Group Type: EXPERIMENTAL

Povidone-Iodine Group

Intervention Type: DRUG

10% Povidone-Iodine for surgical antisepsis according to manufacturer's instructions.

Interventions

Chlorhexidine-alcohol group

2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.

Intervention Type: DRUG

Povidone-Iodine Group

10% Povidone-Iodine for surgical antisepsis according to manufacturer's instructions.

Intervention Type: DRUG

Other Intervention Names

Chloraprep; Betadine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Arvind Palanisamy, MD, FRCA

Assistant Professor of Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arvind Palanisamy, MD, FRCA

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013P002037

Identifier Type: -

Identifier Source: org_study_id