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NCT01472549 · ClinicalTrials.gov registry record · NA
The Skin Prep Study
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 1,147
- Enrollment target
NCT01472549 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 1,147 participants.
The verdict
NCT01472549, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,147 participants
- Enrollment target
Study Summary
The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result in significant human suffering and excess health care costs. Interventions such as preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high. There is therefore a great need to identify and test other potential interventions to further reduce these infections. The skin is a major source of pathogens that cause surgical site infection. Therefore, optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical site infections. There is paucity of evidence to guide the choice of antiseptic for skin preparation at cesarean section. To date, only two underpowered trials have been published comparing two methods of preoperative skin preparation at cesarean section. A recent randomized trial in adults undergoing clean-contaminated mostly general surgical procedures demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is plausible that findings from trials in other clean-contaminated surgical procedures may apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related infections and the hormone-mediated immune-modulation in pregnancy make the validity of such extrapolation uncertain. The study has the following specific aims: Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces surgical site infections compared to iodine-alcohol. Secondary Aim 1: To test the hypothesis that preoperative chlorhexidin
Interventions
- DRUG Iodine-alcohol
- DRUG Chlorhexidine-alcohol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,147 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01472549
The ClinicalTrials.gov registry entry for NCT01472549 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Iodine-alcohol is the first listed.
NCT01472549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01472549 about?
NCT01472549 is a clinical study titled "The Skin Prep Study". The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate...
What is the current status of trial NCT01472549?
This trial is currently completed. It is a NA study. The enrollment target is 1,147 participants. The study started on 2011-09. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01472549?
The interventions under investigation include: Iodine-alcohol (DRUG), Chlorhexidine-alcohol (DRUG).
Who is sponsoring clinical trial NCT01472549?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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