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

Not Applicable

Completed

• Conditions: Hand Disinfection
• Interventions: Device: chlorhexidine; Device: ethyl alcochol, chlorhexidine and moisturizers; Device: povidone-iodine

• Registration Number: NCT02294604
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-15
• Study First Posted: 2014-11-19
• Study Start: 2015-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-10-12
• Results First Submitted QC: 2016-10-12
• Results First Posted: 2016-12-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	chlorhexidine	Traditional scrub formation with 4% chlorhexidine
Group R	ethyl alcochol, chlorhexidine and moisturizers	Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
Group I	povidone-iodine	Traditional scrub formation with 10 % povidone-iodine

Primary Outcome Measures

Name	Time	Method
Microorganisms on Hands Before Scrubbing	2 days after sampling	The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates

Secondary Outcome Measures

Name	Time	Method
Duration of Hand Washing	Immediately	The secondary outcome is the duration of hand washing
Microorganisms on Hands After Scrubbing	2 days after sampling	The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates
Microorganisms on Hands After Surgery	2 days after sampling	The secondary outcomes is the colonies grown on bacterial culture plate