Trial Outcomes & Findings for Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation (NCT NCT00987402)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

3317 participants

Primary outcome timeframe

30 days post-operatively

Results posted on

2012-08-21

Participant Flow

Patients undergoing surgery at AIC Kijabe Hospital recruited between January 2007 to November 2007

Patients who declined consent for participation were excluded, as were those undergoing a second procedure within 2 weeks of the first.

Participant milestones

Participant milestones
Measure	Plain Soap and Water Surgical hand preparation with plain soap and water	Alcohol Based Hand Rubs Surgical hand preparation with alcohol based alcohol hand rub
Overall Study STARTED	1682	1635
Overall Study COMPLETED	1596	1537
Overall Study NOT COMPLETED	86	98

Reasons for withdrawal

Reasons for withdrawal
Measure	Plain Soap and Water Surgical hand preparation with plain soap and water	Alcohol Based Hand Rubs Surgical hand preparation with alcohol based alcohol hand rub
Overall Study Insufficient data entry	86	98

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plain Soap and Water n=1682 Participants Surgical hand preparation with plain soap and water	Alcohol Based Hand Rubs n=1635 Participants Surgical hand preparation with alcohol based alcohol hand rub	Total n=3317 Participants Total of all reporting groups
Age Continuous	28 Participants STANDARD_DEVIATION 23 • n=5 Participants	29 Participants STANDARD_DEVIATION 19 • n=7 Participants	29 Participants STANDARD_DEVIATION 22 • n=5 Participants
Sex: Female, Male Female	964 Participants n=5 Participants	908 Participants n=7 Participants	1872 Participants n=5 Participants
Sex: Female, Male Male	718 Participants n=5 Participants	727 Participants n=7 Participants	1445 Participants n=5 Participants
Region of Enrollment Kenya	1682 participants n=5 Participants	1635 participants n=7 Participants	3317 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Plain Soap and Water n=1682 Participants Surgical hand preparation with plain soap and water	Alcohol Based Hand Rubs n=1635 Participants Surgical hand preparation with alcohol based alcohol hand rub
Surgical Site Infection	128 Participants	127 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Plain Soap and Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alcohol Based Hand Rubs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephan Harbarth MD

University Hospital, Geneva

Phone: +41-22-372.3357

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place