Optimization of Surgical Hand Preparation Using Sorbectol

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

Interventions

OTHER

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

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.

OTHER

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

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.

OTHER

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

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.

OTHER

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

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.

Sponsors & Collaborators

• Universidad Complutense de Madrid

  lead OTHER

Principal Investigators

• PARRA · UNIVERSIDAD COMPLUTENSE MADRID

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-12

Primary Completion

2024-12-18

Completion

2024-12-18

Countries

• Spain

Study Locations