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

January 31, 2017 updated by: Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group R
Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
Device: ethyl alcochol, chlorhexidine and moisturizers
Other Names:
  • Avagard
Active Comparator: Group I
Traditional scrub formation with 10 % povidone-iodine
Device: povidone-iodine
Active Comparator: Group C
Traditional scrub formation with 4% chlorhexidine
Device: chlorhexidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microorganisms on Hands Before Scrubbing
Time Frame: 2 days after sampling
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Chair: Ka-Wai Tam, MD, MS, Taipei Medical University Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 15, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103HCP002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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