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

T

Taipei Medical University

Status

Completed

Conditions

Hand Disinfection

Treatments

Device: chlorhexidine
Device: ethyl alcochol, chlorhexidine and moisturizers
Device: povidone-iodine

Study type

Interventional

Funder types

Other

Identifiers

NCT02294604
103HCP002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

236 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

236 participants in 3 patient groups

Group R
Experimental group
Description:
Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
Treatment:
Device: ethyl alcochol, chlorhexidine and moisturizers
Group I
Active Comparator group
Description:
Traditional scrub formation with 10 % povidone-iodine
Treatment:
Device: povidone-iodine
Group C
Active Comparator group
Description:
Traditional scrub formation with 4% chlorhexidine
Treatment:
Device: chlorhexidine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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