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

Surgical Site Infection Clinical Trial

Official title:

Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446923
• Other study ID #: RICBEC1-UCM
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2020
• Est. completion date: July 20, 2020

Study information

• Verified date: July 2020
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 20, 2020
• Est. primary completion date: July 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Diseases
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Hand antisepsis by scrub
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.
• Hand antisepsis by scrub
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.

Locations

Country	Name	City	State
Spain	Ricardo Becerro de Bengoa Vallejo	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from bacterial load at 5 minutes.
Secondary	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	Change from bacterial load at 3 hours.