Hand DisinfectionNCT02294604
The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room
A study testing ethyl alcochol, chlorhexidine and moisturizers, chlorhexidine and povidone-iodine in people with Hand Disinfection, run by Taipei Medical University Shuang Ho Hospital.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Disinfection
- What is being tested?
- ethyl alcochol, chlorhexidine and moisturizers, chlorhexidine and povidone-iodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Surgical staff members, both surgeons and scrub nurses
Who cannot join
- Participants were excluded if they were medical or nursing students
- Allergy to the experimental materials
About this study
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.
Read the 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.
- Conditions
- Hand Disinfection
- Being tested
- ethyl alcochol, chlorhexidine and moisturizers, chlorhexidine, povidone-iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethyl alcochol, chlorhexidine and moisturizersDevice
Also called Avagard
chlorhexidineDevice
povidone-iodineDevice
| Study group | Role | What they receive |
|---|---|---|
| Group R | Experimental | Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers Receives: Device: ethyl alcochol, chlorhexidine and moisturizers |
| Group I | Active comparator | Traditional scrub formation with 10 % povidone-iodine Receives: Device: povidone-iodine |
| Group C | Active comparator | Traditional scrub formation with 4% chlorhexidine Receives: Device: chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days after sampling
Secondary outcomes (3)
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
Measured: 2 days after sampling
Microorganisms on Hands After Surgery
The secondary outcomes is the colonies grown on bacterial culture plate
Measured: 2 days after sampling
Duration of Hand Washing
The secondary outcome is the duration of hand washing
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hand DisinfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital
- Investigators
- Ka-Wai Tam, MD, MS, Study chair, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294604
- Sponsor's protocol ID
- 103HCP002
- Status last verified
- Jan 2017
- First submitted
- 10 Nov 2014
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room
- ClinicalTrials.gov ID
- NCT02294604
- Acronym / sponsor ID
- 103HCP002
- Conditions
- Hand Disinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 6 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group R | Experimental | Device: ethyl alcochol, chlorhexidine and moisturizersWaterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers |
| Group I | Active comparator | Device: povidone-iodineTraditional scrub formation with 10 % povidone-iodine |
| Group C | Active comparator | Device: chlorhexidineTraditional scrub formation with 4% chlorhexidine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical staff members, both surgeons and scrub nurses
Key exclusion criteria (2 listed)
- Participants were excluded if they were medical or nursing students
- Allergy to the experimental materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethyl alcochol, chlorhexidine and moisturizersAlso: Avagard | Device | Group R |
| chlorhexidine | Device | Group C |
| povidone-iodine | Device | Group I |
Primary outcome
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
3 secondary outcomes
Microorganisms on Hands After Scrubbing
Time frame: 2 days after sampling
Microorganisms on Hands After Surgery
Time frame: 2 days after sampling
Duration of Hand Washing
Time frame: Immediately
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka-Wai Tam, MD, MS study chair
Taipei Medical University Shuang Ho Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ethyl alcochol, chlorhexidine and moisturizers, chlorhexidine and povidone-iodine in people with Hand Disinfection, run by Taipei Medical University Shuang Ho Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microorganisms on Hands Before Scrubbing (time frame: 2 days after sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.