Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing

Phase 4

Completed

• Conditions: Surgical Site Infection; Skin Diseases
• Interventions: Drug: Hand antisepsis by scrub

• Registration Number: NCT04446923
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2020-06-28
• Status Verified: 2020-07
• Primary Completion: 2020-07-18
• Study Completion: 2020-07-20
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hand antisepsis by rub	Hand antisepsis by scrub	Hand antisepsis by rub using propan-ol-1 60%
Hand antisepsis by scrub	Hand antisepsis by scrub	Hand antisepsis by scrub using propan-ol-1 60%

Primary Outcome Measures

Name	Time	Method
Reduction of bacterial load immediately after hand scrub	Change from bacterial load at 5 minutes.	Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.

Secondary Outcome Measures

Name	Time	Method
Reduction of bacterial load after 3 hours of hand scrub	Change from bacterial load at 3 hours.	Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure after 3 hours

Trial Locations

Locations (1)

Ricardo Becerro de Bengoa Vallejo; 🇪🇸 Madrid, Spain