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

NCT02294604 | Completed Results DMC

• 1 other identifier: 103HCP002
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hand Disinfection

Outcome Measures

Primary Outcomes (1)

• Microorganisms on Hands Before Scrubbing

  The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates

  2 days after sampling

Secondary Outcomes (3)

• Microorganisms on Hands After Scrubbing

  2 days after sampling

• Microorganisms on Hands After Surgery

  2 days after sampling

• Duration of Hand Washing

  Immediately

Study Arms (3)

Group R

EXPERIMENTAL

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

Device: ethyl alcochol, chlorhexidine and moisturizers

Group I

ACTIVE COMPARATOR

Traditional scrub formation with 10 % povidone-iodine

Device: povidone-iodine

Group C

ACTIVE COMPARATOR

Traditional scrub formation with 4% chlorhexidine

Device: chlorhexidine

Interventions

ethyl alcochol, chlorhexidine and moisturizers DEVICE

Also known as: Avagard

Group R

chlorhexidine DEVICE

Group C

povidone-iodine DEVICE

Group I

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical staff members, both surgeons and scrub nurses

You may not qualify if:

• Participants were excluded if they were medical or nursing students
• Allergy to the experimental materials

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Results Point of Contact

• Title: Dr. Ka-Wai Tam
• Organization: Shuang Ho Hospital, Taipei Medical University

kelvintam@h.tmu.edu.tw

886-2-22490088

Study Officials

• Ka-Wai Tam, MD, MS

  Taipei Medical University Shuang Ho Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Evidence-Based Health Care

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 19, 2014
• Study Start: April 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 13, 2017
• Results First Posted: December 6, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share