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

Hand Disinfection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294604
• Other study ID #: 103HCP002
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: May 20, 2015
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hand Disinfection

Intervention

Device:
• ethyl alcochol, chlorhexidine and moisturizers

• chlorhexidine

• povidone-iodine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Microorganisms on hands after scrubbing	The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates	2 days after sampling	Yes