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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202577
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Edward Henry Springel, MD, Case Western Reserve University

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 Red CAP 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).

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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


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




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


Secondary Outcome Measures :
  1. Non-infections surgical site complications [ Time Frame: 4 weeks after cesarean delivery ]
    Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202577


Locations
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United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109-1998
Sponsors and Collaborators
Edward Henry Springel, MD
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edward Henry Springel, MD, Fellow/Faculty Maternal Fetal Medicine MetroHealth/Case Western Reserve University, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT02202577    
Other Study ID Numbers: SPR-13-01063
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Edward Henry Springel, MD, Case Western Reserve University:
Surgical site infection
Surgical site antisepsis
Cesarean Delivery
Additional relevant MeSH terms:
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Surgical Wound Infection
Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Plasma Substitutes
Blood Substitutes