Surgical Site InfectionCAPICANCT02202577
Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis
A study testing Chlorhexidine - Isopropyl alcohol and Povidone-Iodine Scrub and Paint in people with Surgical Site Infection, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Chlorhexidine - Isopropyl alcohol and Povidone-Iodine Scrub and Paint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 932 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cesarean delivery
- age 18-65
- ability to consent in English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
About this study
Official title: 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.
Read the 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).
- Conditions
- Surgical Site Infection
- Being tested
- Chlorhexidine - Isopropyl alcohol, Povidone-Iodine Scrub and Paint
- Keywords
- Surgical site infection, Surgical site antisepsis, Cesarean Delivery
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine - Isopropyl alcoholDrug
Also called Chlora-Prep
Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
Povidone-Iodine Scrub and PaintDrug
Also called Betadine
Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine - Isopropyl alcohol | Experimental | Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol Receives: Drug: Chlorhexidine - Isopropyl alcohol |
| Povidone-Iodine Scrub and Paint | Experimental | Pre-operative skin preparation with Povidone-Iodine Scrub and Paint Receives: Drug: Povidone-Iodine Scrub and Paint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after cesarean delivery
Secondary outcomes (1)
Number of Patients With Non-infections Surgical Site Complications
Non-infection complications: allergic skin reactions, hematomas, wound separation, dehiscence.
Measured: 4 weeks after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian B Mercer, MD, Principal investigator, MetroHealth Medical Center/Case Western ReserveEdward H Springel, MD, Principal investigator, MetroHealth Medical Center/Case Western Reserve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202577
- Sponsor's protocol ID
- SPR-13-01063
- Acronym
- CAPICA
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2014
- Last updated
- 21 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 20054046Hadiati 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.
PubMed 32580252Springel 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.
PubMed 28599898
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine-Alcohol Versus Povidone-Iodine for Surgical Site Antisepsis Prior to Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02202577
- Acronym / sponsor ID
- CAPICA / SPR-13-01063
- Conditions
- Surgical Site Infection
- Keywords
- Surgical site infection, Surgical site antisepsis, Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 932 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Posted 21 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine - Isopropyl alcohol | Experimental | Drug: Chlorhexidine - Isopropyl alcoholPre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol |
| Povidone-Iodine Scrub and Paint | Experimental | Drug: Povidone-Iodine Scrub and PaintPre-operative skin preparation with Povidone-Iodine Scrub and Paint |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cesarean delivery
- age 18-65
- ability to consent in English or Spanish
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine - Isopropyl alcoholAlso: Chlora-PrepApplied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA | Drug | Chlorhexidine - Isopropyl alcohol |
| Povidone-Iodine Scrub and PaintAlso: BetadineApplied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA | Drug | Povidone-Iodine Scrub and Paint |
Primary outcome
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.
1 secondary outcome
Number of Patients With Non-infections Surgical Site Complications
Time frame: 4 weeks after cesarean delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20054046Darouiche 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.
- Derived from this study: PubMed 32580252Hadiati 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.
- Derived from this study: PubMed 28599898Springel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian B Mercer, MD principal investigator
MetroHealth Medical Center/Case Western Reserve
Edward H Springel, MD principal investigator
MetroHealth Medical Center/Case Western Reserve
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine - Isopropyl alcohol and Povidone-Iodine Scrub and Paint in people with Surgical Site Infection, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Surgical Site Infection (time frame: 4 weeks after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02202577, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.