Optimization of Surgical Hand Preparation Using Sorbectol

NCT06688890 | Recruiting

• 1 other identifier: SORBUCM_MP
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies evaluated the efficacy of the hydroalcoholic solution of 3% digluconate of chlorhexidine, 0.3% potassium sorbate and 70% ethanol, "Sorbectol" (Spanish patent ES 2 784 275 B2) in the surgical hand preparation with positive results. This clinical trial is focused on optimising the effectiveness of Sorbectol in the surgical hand preparation by scaling the application times of the product from 1 to 5 minutes following the test procedure and the effectiveness criteria of the European norm EN-12791.

Conditions

Hand Washing

Keywords

Sorbectol; bacterial load; inmediate effect; prolongated effect

Outcome Measures

Primary Outcomes (2)

• Immediate effect assessed immediately after surgical hand antisepsis

  It refers to the reduction in bacterial load (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) achieved immediately after the application of surgical hand antisepsis in one of the hands. The immediate effect is calculated by using the expression Log CFU/ml of immediate pre-values minus Log CFU/ml of immediate post-values, where the immediate pre-values are the bacterial counts pre-existing on the selected hand for immediate effect before disinfection, at the time point 0, and the immediate post-values are the bacterial counts determined on the same hand after the application of the antiseptic, at the time point 1.This primary outcome measure is used to evaluate the non-inferiority criterium proposed by the EN 12791 for tested antiseptic protocols, P1, P2 and P3 vs. RP.

  Immediate effect is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]

• Effect assessed 3-hours after surgical hand antisepsis

  It refers to the reduction in bacterial load (expressed as the decimal logarithm, Log, of colony-forming units per milliliter of sample, CFU/ml) achieved 3 hours after of the surgical hand antisepsis on the opposite hand used for immediate effect determination. The 3-hours effect is calculated by using the expression Log CFU/ml of 3-hours pre-values minus Log CFU/ml of 3-hours post-values, where the 3-hours pre-values are the bacterial count pre-existing on the selected hand for 3-hours effect determination before disinfection, at the time point 0, and the 3-hours post-values are the bacterial count determined on the same hand 3-hours after the application of the antiseptic, at the time point 2.This primary outcome measure is used to evaluate the non-inferiority and sustained effect criteria proposed by the EN 12791 for tested antiseptic protocols, P1, P2 and P3 vs. RP.

  The 3-hours effect is a measure determined at the time point 2 which is 3 hours after the immediate effect determination]

Secondary Outcomes (3)

• Bacterial counts preexisting on the hands before surgical hand antisepsis. Pre-values.

  Prevalues is a measure determined at the time point 0 which represent the beginning of the disinfection assay

• Bacterial counts immediately after surgical hand antisepsis. Immediate post-values

  Immediate post-value is a measure determined at the time point 1, within the first 10 minutes of disinfection assay. The specific duration is subject to variation based on the particular application protocol of P1, P2, P3 and RP.]

• Bacterial counts 3-hours after surgical hand antisepsis. 3-hours post-values

  3-hours post-value is a measure determined at the time point 2, which is 3 hours after the immediate post-value determination.

Study Arms (4)

1. Surgical hand rub with the reference product; n-propanol 60%.

EXPERIMENTAL

Other: Surgical hand rub with the reference product; n-propanol 60%.

2. Surgical hand rub with the product P1; Sorbectol for 1 min.

EXPERIMENTAL

Other: Surgical hand rub with the product P1; Sorbectol for 1 min.

3. Surgical hand rub with the product P2;Sorbectol for 3 min.

EXPERIMENTAL

Other: Surgical hand rub with the product P2; Sorbectol for 3 min.

4. Surgical hand rub with the product P3; Sorbectol for 5 min.

EXPERIMENTAL

Other: Surgical hand rub with the product P3; Sorbectol for 5 min.

Interventions

Surgical hand rub with the reference product; n-propanol 60%. OTHER

Propanol hand rub for 3 min. The applied volume of product is sufficient to keep the hand moist for a total time of 3 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.

1. Surgical hand rub with the reference product; n-propanol 60%.

Surgical hand rub with the product P1; Sorbectol for 1 min. OTHER

Sorbectol hand rub for 1 min. The applied volume of product is sufficient to keep the hand moist for a total time of 1 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.

2. Surgical hand rub with the product P1; Sorbectol for 1 min.

Surgical hand rub with the product P2; Sorbectol for 3 min. OTHER

Sorbectol hand rub for 3 min. The applied volume of product is sufficient to keep the hand moist for a total time of 3 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.

3. Surgical hand rub with the product P2;Sorbectol for 3 min.

Surgical hand rub with the product P3; Sorbectol for 5 min. OTHER

Sorbectol hand rub for 5 min. The applied volume of product is sufficient to keep the hand moist for a total time of 5 min, adding as many 3 ml portions as necessary according to EN 12791. According to the EN 1279, the role assigned to each hand (immediate or 3h effect) in the first run is swapped in the subsequent runs.

4. Surgical hand rub with the product P3; Sorbectol for 5 min.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with healthy skin in both hands and short fingernails.
• No use of antibacterial agents for at least three days before the intervention.
• Not received antibiotic treatment for at least ten days before the intervention.

You may not qualify if:

• Known systemic pathologies.
• Wearing hand jewelry on the hands.
• Allergy to any ingredient of which the solutions used in the clinical trial are composed.
• Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

RECRUITING

Related Publications (2)

• Rutala WA, Boyce JM, Weber DJ. Disinfection, sterilization and antisepsis: An overview. Am J Infect Control. 2023 Nov;51(11S):A3-A12. doi: 10.1016/j.ajic.2023.01.001.

  PMID: 37890951 BACKGROUND

• Herraiz Soria E, Alou L, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias M, Sevillano D. Alcohol-Based Chlorhexidine and Potassium Sorbate Rub Strengthens the Effectiveness of Traditional Hand Scrubbing and Improves Long-Lasting Effectiveness-Evaluation of Hand Preparation Protocols According to EN 12791. Antibiotics (Basel). 2024 May 20;13(5):470. doi: 10.3390/antibiotics13050470.

  PMID: 38786198 BACKGROUND

Study Officials

• PARRA

  UNIVERSIDAD COMPLUTENSE MADRID

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PARRA

CONTACT

+34916500390; mariadelmar.parra@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants ignore which product is being used in each intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: podiatry and researcher in Health Sciences

Model Details: clinical trial, randomized, crossover.

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: November 14, 2024
• Study Start: July 12, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

ES (1)