Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Washington University School of Medicine.
NCT01472549 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 1,147 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.
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 |
What the finished NCT01472549 record still lists
NCT01472549 is an interventional study that assigns participants to a tested intervention. Its 1,147 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Iodine-alcohol is the first listed.
NCT01472549 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01472549's enrollment target sits among peer trials
1,147 92nd of 2000 higher than 1,909 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06676319 · 1,147 participants · Phase 2
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
- NCT06129864 · 1,145 participants · Phase 3
A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
- NCT06408181 · 1,150 participants · Phase 3
APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
- NCT06528314 · 1,150 participants · Phase 3
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia