Post-operative Infection: Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
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 3133 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.
Description
We generated power calculations assuming a 2-sided alpha error (Type 1) of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10, or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30% and 50%) in SSI rates in those periods that implemented the ABHR strategy compared to conventional PSW.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Conditions
Surgical Site Infections
Intervention
Surgical site infections after surgical hand preparation using plain soap and water compared to alcohol based hand rubs
Location
Africa Inland Church Kijabe Hospital
Kijabe
Central
Kenya
00220
Status
Completed
Source
University Hospital, Geneva
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00987402
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Surgical Equipment
Nonexpendable apparatus used during surgical procedures. They are differentiated from SURGICAL INSTRUMENTS, usually hand-held and used in the immediate operative field.
Surgical Attire
Sterile clothing worn during surgical procedures to protect the surgical site from sources of contamination.
Surgical Instruments
Hand-held tools or implements used by health professionals for the performance of surgical tasks.
Diagnostic Techniques, Surgical
Methods and procedures for the diagnosis of disease or dysfunction by examination of the pathological site or operative field during surgical intervention.
Surgical Drapes
Sterile fabric or fabric-like material used to isolate the surgical site from the rest of the body and other possible sources of contamination.
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