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

• ClinicalTrials.gov Identifier: NCT02202577
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Results First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Sponsor: Case Western Reserve University
• Information provided by (Responsible Party): Case Western Reserve University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Surgical Site Infection	Drug: Chlorhexidine - Isopropyl alcohol; Drug: Povidone-Iodine Scrub and Paint	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 932 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery
• Study Start Date: March 2014
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

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 Name: 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 Name: Betadine

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Ohio

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109-1998

Sponsors and Collaborators

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

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT02202577
• Other Study ID Numbers: SPR-13-01063
• First Posted: July 29, 2014
• Results First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Case Western Reserve University:

Surgical site infection; Surgical site antisepsis; Cesarean Delivery

Additional relevant MeSH terms:

Surgical Wound Infection; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Chlorhexidine; Povidone-Iodine; Povidone; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Plasma Substitutes; Blood Substitutes