Postoperative Wound Infection Clinical Trial
Official 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
Verified date | November 2009 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | Kenya: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3317 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Kenya | Africa Inland Church Kijabe Hospital | Kijabe | Central |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | AIC Kijabe Hospital, World Health Organization |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | No |
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