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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| AIC Kijabe Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain soap and water | Active Comparator | Surgical hand preparation with plain soap and water |
|
| Alcohol based hand rubs | Active Comparator | Surgical hand preparation with alcohol based alcohol hand rub |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plain soap and water (PSW) | Other | Presence or absence of infection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Nthumba, MD | AIC Kijabe Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Africa Inland Church Kijabe Hospital | Kijabe | Central | 00220 | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22297835 | Derived | Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x. | |
| 20878941 | Derived | Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213. |
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Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.
Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Plain Soap and Water | Surgical hand preparation with plain soap and water |
| FG001 | Alcohol Based Hand Rubs | Surgical hand preparation with alcohol based alcohol hand rub |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plain Soap and Water | Surgical hand preparation with plain soap and water |
| BG001 | Alcohol Based Hand Rubs | Surgical hand preparation with alcohol based alcohol hand rub |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Not Posted | Mean | Standard Deviation | Euros | 30 days | |||||||||
| 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). | Posted | Oct 2009 | Number |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plain Soap and Water | Surgical hand preparation with plain soap and water |
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Most cases, post-discharge monitoring was not conducted by outpatient clinic visits following a standard protocol, some data was not collected, and routine microbiologic cultures were not obtained.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Harbarth MD | University Hospital, Geneva | +41-22-372.3357 | stephan.harbarth@hcuge.ch |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014867 | Water |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Alcohol-based hand rub (ABHR) | Other | Presence or absence of infection |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
| 30 days post-operatively |
|
|
|
|
| 0 |
| 1,596 |
| 0 |
| 1,596 |
| EG001 | Alcohol Based Hand Rubs | Surgical hand preparation with alcohol based alcohol hand rub | 0 | 1,537 | 0 | 1,537 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |