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CompletedNCT04446923Updated Jul 21, 2020

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

A Phase 4 interventional study of Hand antisepsis by scrub and Hand antisepsis by scrub in Skin Diseases and Surgical Site Infection, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by Universidad Complutense de Madrid · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Skin Diseases
  • Surgical Site Infection

Keywords

  • hand antisepsis
03

In context

Surgical Wound Infection

670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.

This study's enrollment of 24 is below the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Taken antibiotics before 10 days of the intervention.
  • Wear any jewellery on the hands.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Hand antisepsis by scrub

    Hand antisepsis by scrub using propan-ol-1 60%

    Drug: Hand antisepsis by scrub

  • Active comparator
    Hand antisepsis by rub

    Hand antisepsis by rub using propan-ol-1 60%

    Drug: Hand antisepsis by scrub

Interventions

  • DrugHand 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.

    Also known as: Propanolol

  • DrugHand 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.

    Also known as: Propanolol

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from bacterial load at 5 minutes.

Secondary outcomes

  1. 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

    Time frame: Change from bacterial load at 3 hours.

07

Study locations

1 site
  • Ricardo Becerro de Bengoa Vallejo
    Madrid, 28040, Spain
08

References and documents

Individual participant data

Plan to share: No — A number will be assigned to each participant

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04446923
Lead sponsor
Universidad Complutense de Madrid
Responsible party
César Calvo Lobo (Principal Investigator, Universidad Complutense de Madrid) — Principal investigator
First posted
Jun 25, 2020
Start date
Jun 28, 2020
Primary completion
Jul 18, 2020
Completion
Jul 20, 2020
Last update
Jul 21, 2020

Study contacts

Ricardo Becerro de Bengoa Vallejo, PhD
principal investigator · Ricardo becerro de Bengoa Vallejo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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