Back to resultsSurgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
Primary Purpose
Skin Diseases, Surgical Site Infection
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hand antisepsis by scrub
Hand antisepsis by scrub
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases focused on measuring hand antisepsis
Eligibility Criteria
Inclusion Criteria:
- Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
- They do not use substances with antibacterial action.
Exclusion Criteria:
- Taken antibiotics before 10 days of the intervention.
- Wear any jewellery on the hands.
Sites / Locations
- Ricardo Becerro de Bengoa Vallejo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hand antisepsis by scrub
Hand antisepsis by rub
Arm Description
Hand antisepsis by scrub using propan-ol-1 60%
Hand antisepsis by rub using propan-ol-1 60%
Outcomes
Primary Outcome Measures
Reduction of bacterial load immediately after hand scrub
Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.
Secondary Outcome Measures
Reduction of bacterial load after 3 hours of hand scrub
Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure after 3 hours
Full Information
NCT ID
NCT04446923
First Posted
June 22, 2020
Last Updated
July 20, 2020
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04446923
Brief Title
Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
Official Title
Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2020 (Actual)
Primary Completion Date
July 18, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.
Detailed Description
The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Surgical Site Infection
Keywords
hand antisepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Crossover design is used
Masking
Outcomes Assessor
Masking Description
The samples will be sent to the laboratory with numbers.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand antisepsis by scrub
Arm Type
Experimental
Arm Description
Hand antisepsis by scrub using propan-ol-1 60%
Arm Title
Hand antisepsis by rub
Arm Type
Active Comparator
Arm Description
Hand antisepsis by rub using propan-ol-1 60%
Intervention Type
Drug
Intervention Name(s)
Hand antisepsis by scrub
Other Intervention Name(s)
Propanolol
Intervention Description
Surgical Hand scrubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
Intervention Type
Drug
Intervention Name(s)
Hand antisepsis by scrub
Other Intervention Name(s)
Propanolol
Intervention Description
Surgical Hand rubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
Primary Outcome Measure Information:
Title
Reduction of bacterial load immediately after hand scrub
Description
Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.
Time Frame
Change from bacterial load at 5 minutes.
Secondary Outcome Measure Information:
Title
Reduction of bacterial load after 3 hours of hand scrub
Description
Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure after 3 hours
Time Frame
Change from bacterial load at 3 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
They do not use substances with antibacterial action.
Exclusion Criteria:
Taken antibiotics before 10 days of the intervention.
Wear any jewellery on the hands.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Becerro de Bengoa Vallejo, PhD
Organizational Affiliation
Ricardo becerro de Bengoa Vallejo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ricardo Becerro de Bengoa Vallejo
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
A number will be assigned to each participant
Learn more about this trial
Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing
We'll reach out to this number within 24 hrs