Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis (CAPICA)

Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery

Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Chlorhexidine - Isopropyl alcohol; Drug: Povidone-Iodine Scrub and Paint

Detailed Description

Patients who are considered likely to need cesarean delivery or who are planning cesarean will be recruited and consented for study participation during prenatal care and/or at time of admission to labor and delivery.

Patients undergoing cesarean who meet inclusion/exclusion criteria will be randomized to one of two surgical preparations as listed above (1. Chlorhexidine Gluconate (CHG)-alcohol, or 2. Povidone Iodine (P-I) scrub and paint. Randomization will be performed by the consenting surgeon (listed as key personnel) after the patient has arrived into the operating room for cesarean. Pre-operative surgical site antisepsis will be performed according to randomization. All other surgical practices will remain at the surgeon's discretion according to standard of care at Metrohealth.

Patients will be examined daily by the obstetric team and evaluated for signs and symptoms of surgical site infection, as standard in the investigators institution. The chart will be reviewed to determine if the patient was diagnosed during admission, or, re-admitted because of surgical site infection. The patient will also be questioned regarding any treatment or diagnosis of Surgical Site Infection (SSI) that occured after discharge to home at the routine six week post-operative visit. If patient does not return for the routine post-operative visit, the investigator will attempt to contact the patient by telephone to determine if the patient had been diagnosed or treated for surgical site infection. If patient is lost to 6 week follow up, subanalysis will be performed on available data derived from hospitalization and hospital Electronic Medical Record (EMR).

Data will be captured in RedCAP database.

Additional data will be captured that may affect patient likelihood of surgical site infection to ensure that both groups are statistically equal in risk factors for SSI: labor or rupture of membranes prior to cesarean, maternal age, estimated gestational age, Body Mass Index (BMI), gravity, parity, race, smoking status, hypertensive morbidity, diabetes, estimated blood loss, operative time, race, insurance type, general versus regional anesthesia, appropriate antibiotic prophylaxis given, skin closure (sutures v. staples).

Power analysis was performed: assuming 7.5% risk of cesarean site infection and a 50% reduction with chlorhexidine, 932 individuals will be recruited. Approximately 800 cesareans are performed at the investigators institution per year and the investigators anticipate that 80% will be eligible to participate.

Data review will be done every 6 months or every 200 patients and analyzed, whichever is sooner. Analysis will be performed by the Primary Investigators (PI) for completeness, accuracy, strict adherence to study protocol, safety, and statistical significance. The investigators site is also subject to periodic audits by the investigators Institutional Review Board (IRB).

• Study Type: Interventional
• Enrollment (Actual): 932
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109-1998
      • MetroHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• cesarean delivery
• age 18-65
• ability to consent in English or Spanish

Exclusion Criteria:

• inability or unwillingness to consent to study participation in English or Spanish
• current incarceration
• pre-operative diagnosis of chorioamnionitis
• perceived inability to complete follow up for data collection
• any prior known allergy or adverse reaction to either study preparation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine - Isopropyl alcohol; Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol	Drug: Chlorhexidine - Isopropyl alcohol; Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA; Other Names: Chlora-Prep
Experimental: Povidone-Iodine Scrub and Paint; Pre-operative skin preparation with Povidone-Iodine Scrub and Paint	Drug: Povidone-Iodine Scrub and Paint; Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA; Other Names: Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Surgical Site Infection	Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.	4 weeks after cesarean delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Non-infections Surgical Site Complications	Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.	4 weeks after cesarean delivery

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Brian B Mercer, MD, MetroHealth Medical Center/Case Western Reserve; Principal Investigator: Edward H Springel, MD, MetroHealth Medical Center/Case Western Reserve

Publications and helpful links

General Publications

• Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
• Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.
• Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 25, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 29, 2014

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cesarean Delivery; Surgical site infection; Surgical site antisepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone
• Other Study ID Numbers: SPR-13-01063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No