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The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room

NCT ID: NCT02294604

Last Updated: 2017-03-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable antiseptic effect. The investigators perform a randomized controlled trial to compare the antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with povidone-iodine and chlorhexidine solutions.

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Detailed Description

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This single centre, randomized trial recruited surgical team members in Taipei Medical University-Shuang Ho Hospital at November 2014. 255 episodes of hand washing are enrolled. The participants are assigned equally to use either a waterless hand rub (Group R), or traditional scrub formation with 10 % povidone-iodine (Group I) and 4% chlorhexidine (Group C). Hand washing time, microorganisms on hands before and after scrubbing is recorded. The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates after hand washing. The secondary outcomes is hand microbial flora after surgery and duration of hand washing.

Conditions

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Hand Disinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group R

Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers

Group Type EXPERIMENTAL

ethyl alcochol, chlorhexidine and moisturizers

Intervention Type DEVICE

Group I

Traditional scrub formation with 10 % povidone-iodine

Group Type ACTIVE_COMPARATOR

povidone-iodine

Intervention Type DEVICE

Group C

Traditional scrub formation with 4% chlorhexidine

Group Type ACTIVE_COMPARATOR

chlorhexidine

Intervention Type DEVICE

Interventions

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ethyl alcochol, chlorhexidine and moisturizers

Intervention Type DEVICE

chlorhexidine

Intervention Type DEVICE

povidone-iodine

Intervention Type DEVICE

Other Intervention Names

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Avagard

Eligibility Criteria

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Inclusion Criteria

* Surgical staff members, both surgeons and scrub nurses

Exclusion Criteria

* Participants were excluded if they were medical or nursing students
* Allergy to the experimental materials
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ka-Wai Tam

Director of Center for Evidence-Based Health Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka-Wai Tam, MD, MS

Role: STUDY_CHAIR

Taipei Medical University Shuang Ho Hospital

Other Identifiers

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103HCP002

Identifier Type: -

Identifier Source: org_study_id

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