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

University Hospitals (UH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postoperative Wound Infection

Treatments: Other: Alcohol-based hand rub (ABHR); Other: Plain soap and water (PSW)

Study type: Interventional

Funder types: Other

Identifiers

NCT00987402

KH-PSW-ABHR

Details and patient eligibility

About

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.

Enrollment: 3,317 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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3,317 participants in 2 patient groups

Plain soap and water

Active Comparator group

Description:

Surgical hand preparation with plain soap and water

Treatment:

Other: Plain soap and water (PSW)

Alcohol based hand rubs

Active Comparator group

Description:

Surgical hand preparation with alcohol based alcohol hand rub

Treatment:

Other: Alcohol-based hand rub (ABHR)