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Completed

NCT Number: NCT00987402

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

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.

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Key information

Conditions

Postoperative Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Africa Inland Church Kijabe Hospital

Kijabe, Central, 00220, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plain soap and water (PSW)

Other

Presence or absence of infection

Other names: Plain bar soap, WHO recommended alcohol based hand rub formulation II

Alcohol-based hand rub (ABHR)

Other

Presence or absence of infection

Primary outcomes

  1. Surgical Site Infection

    Time frame: 30 days post-operatively

    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).

Secondary outcomes

  1. Cost of Hand Preparation Agent

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • AIC Kijabe Hospital
  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 1, 2009
Registry last updated
Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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