Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02202577 |
| Other study ID # |
SPR-13-01063 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2014 |
| Est. completion date |
July 2016 |
Study information
| Verified date |
July 2022 |
| Source |
Case Western Reserve University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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).
