Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis (CAPICA)
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine - Isopropyl alcohol
Povidone-Iodine Scrub and Paint
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Site Infection focused on measuring Surgical site infection, Surgical site antisepsis, Cesarean Delivery
Eligibility 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
Sites / Locations
- MetroHealth Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Chlorhexidine - Isopropyl alcohol
Povidone-Iodine Scrub and Paint
Arm Description
Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol
Pre-operative skin preparation with Povidone-Iodine Scrub and Paint
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Patients With Non-infections Surgical Site Complications
Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.
Full Information
NCT ID
NCT02202577
First Posted
July 25, 2014
Last Updated
July 18, 2022
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT02202577
Brief Title
Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis
Acronym
CAPICA
Official Title
Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Western Reserve University
4. Oversight
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Surgical site infection, Surgical site antisepsis, Cesarean Delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
932 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine - Isopropyl alcohol
Arm Type
Experimental
Arm Description
Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol
Arm Title
Povidone-Iodine Scrub and Paint
Arm Type
Experimental
Arm Description
Pre-operative skin preparation with Povidone-Iodine Scrub and Paint
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine - Isopropyl alcohol
Other Intervention Name(s)
Chlora-Prep
Intervention Description
Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine Scrub and Paint
Other Intervention Name(s)
Betadine
Intervention Description
Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Primary Outcome Measure Information:
Title
Number of Patients With Surgical Site Infection
Description
Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.
Time Frame
4 weeks after cesarean delivery
Secondary Outcome Measure Information:
Title
Number of Patients With Non-infections Surgical Site Complications
Description
Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.
Time Frame
4 weeks after cesarean delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian B Mercer, MD
Organizational Affiliation
MetroHealth Medical Center/Case Western Reserve
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward H Springel, MD
Organizational Affiliation
MetroHealth Medical Center/Case Western Reserve
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20054046
Citation
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.
Results Reference
background
PubMed Identifier
32580252
Citation
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.
Results Reference
derived
PubMed Identifier
28599898
Citation
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.
Results Reference
derived
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Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis
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