Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Wound Infection

Intervention / Treatment
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* Other: Plain soap and water (PSW)
* Other: Alcohol-based hand rub (ABHR)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain soap and water<br>Surgical hand preparation with plain soap and water | Other: Plain soap and water (PSW)<br>* Presence or absence of infection<br>* Other names: WHO recommended alcohol based hand rub formulation II;|
| Active Comparator: Alcohol based hand rubs<br>Surgical hand preparation with alcohol based alcohol hand rub | Other: Alcohol-based hand rub (ABHR)<br>* Presence or absence of infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection | 255 (8.1%) patients developed SSIs. Rates for the two study arms were similar (8.3% for alcohol-based handrub versus 8.0% for plain soap and water; odds ratio, 1.03; 95% CI, 0.80 - 1.33). | 30 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Hand Preparation Agent | Average weekly costs were estimated for the plain soap and water used each week in the operating room as well as for the procurement, preparation and dispensing of the alcohol-based handrub to enable a comparison between the two study arms. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand scrubbing, post-operative infection, surgical site infection, surgical hand preparation, plain soap and water, alcohol-based hand rub, Cost of surgical hand preparation agent, Side effects of use of hand preparation agent, Surgery