CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3,317 enrolled
Drug / intervention
Plain soap and water (PSW) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00987402
NCT00987402Phase 2Completed
CompareCT.gov

Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation

University Hospital, Geneva·interventional·Posted Oct 1, 2009·Updated Aug 21, 2012

In Brief

A Phase 2 clinical trial evaluating Plain soap and water (PSW) and Alcohol-based hand rub (ABHR) for Postoperative Wound Infection. Completed, enrolled 3,317 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Wound Infection
CountriesKenya
CollaboratorsWorld Health Organization, AIC Kijabe Hospital

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2009
Enrollment StartJan 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.8 years ago

Interventions

Plain soap and water (PSW)other

Presence or absence of infection

Alcohol-based hand rub (ABHR)other

Presence or absence of infection