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

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Completed
• CT.gov ID: NCT00987402
• Collaborator: World Health Organization (Other), AIC Kijabe Hospital (Other)
• Enrollment: 3,317
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 332.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Wound Infection	Other: Plain soap and water (PSW); Other: Alcohol-based hand rub (ABHR)	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3317 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Plain soap and water Surgical hand preparation with plain soap and water	Other: Plain soap and water (PSW); Presence or absence of infection; Other Names: Plain bar soap WHO recommended alcohol based hand rub formulation II
Active Comparator: Alcohol based hand rubs Surgical hand preparation with alcohol based alcohol hand rub	Other: Alcohol-based hand rub (ABHR); Presence or absence of infection

Outcome Measures

Primary Outcome Measures

1. Surgical Site Infection [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 Outcome Measures

1. Cost of Hand Preparation Agent [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Africa Inland Church Kijabe Hospital	Kijabe	Central	Kenya	00220

Sponsors and Collaborators

• University Hospital, Geneva
• World Health Organization
• AIC Kijabe Hospital

Investigators

• Principal Investigator: Peter M Nthumba, MD, AIC Kijabe Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00987402
• Other Study ID Numbers: KH-PSW-ABHR
• First Posted: Oct 1, 2009
• Last Update Posted: Aug 21, 2012
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: Surgery; 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
• Additional relevant MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Ethanol

Study Results

Participant Flow

Recruitment Details	Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007
Pre-assignment Detail	Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.

Arm/Group Title	Plain Soap and Water	Alcohol Based Hand Rubs
Arm/Group Description	Surgical hand preparation with plain soap and water	Surgical hand preparation with alcohol based alcohol hand rub
Period Title: Overall Study
STARTED	1682	1635
COMPLETED	1596	1537
NOT COMPLETED	86	98

Baseline Characteristics

Arm/Group Title	Plain Soap and Water	Alcohol Based Hand Rubs	Total
Arm/Group Description	Surgical hand preparation with plain soap and water	Surgical hand preparation with alcohol based alcohol hand rub	Total of all reporting groups
Overall Participants	1682	1635	3317
Age (Mean) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Participants]	28 (23) 1.7%	29 (19) 1.8%	29 (22) 0.9%
Sex: Female, Male (Count of Participants)
Female	964 57.3%	908 55.5%	1872 56.4%
Male	718 42.7%	727 44.5%	1445 43.6%
Region of Enrollment (participants) [Number]
Kenya	1682 100%	1635 100%	3317 100%

Outcome Measures

1. Secondary Outcome

Title	Cost of Hand Preparation Agent
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

Title	Surgical Site Infection
Description	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).
Time Frame	30 days post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plain Soap and Water	Alcohol Based Hand Rubs
Arm/Group Description	Surgical hand preparation with plain soap and water	Surgical hand preparation with alcohol based alcohol hand rub
Measure Participants	1682	1635
Number [Participants]	128 7.6%	127 7.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Plain Soap and Water, Alcohol Based Hand Rubs
	Comments	Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	generalized estimating equation
	Comments

Adverse Events

Arm/Group Title	Plain Soap and Water		Alcohol Based Hand Rubs
Arm/Group Description	Surgical hand preparation with plain soap and water		Surgical hand preparation with alcohol based alcohol hand rub
All Cause Mortality
	Plain Soap and Water		Alcohol Based Hand Rubs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Plain Soap and Water		Alcohol Based Hand Rubs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1596 (0%)		0/1537 (0%)
Other (Not Including Serious) Adverse Events
	Plain Soap and Water		Alcohol Based Hand Rubs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1596 (0%)		0/1537 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.