Phase 2
N=3,317
Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
Postoperative Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT00987402 ↗Enrolled (actual)
3,317
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Surgical Site Infection — 128; 127 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plain soap and water (PSW) (Other); Alcohol-based hand rub (ABHR) (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University Hospital, Geneva
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Site Infection |
128; 127 | <0.05 sig |
| SECONDARY Cost of Hand Preparation Agent |
— | — |
Summary
Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.
A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
Eligibility Criteria
Inclusion Criteria
- All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital
Exclusion Criteria
- All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
- Patients who did not consent to participate in the study
Data sourced from ClinicalTrials.gov (NCT00987402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.