Optimization of Surgical Hand Preparation Using Sorbectol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2024-12-18

Brief Summary

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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.

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Detailed Description

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This is a randomised clinical trial with a Latin-square crossover design, to test the effectiveness of the Sorbectol solution in surgical hand preparation, according to the EN 12791 standard, at application times of 1, 3 or 5 minutes. The test compares the bacterial load on the hands of at least 23 healthy volunteers immediately (immediate effect) and three hours after (3-hour effect) application of the test product with respect to the reference product, RP, of EN 12791 (n-propanol 60%).

Briefly: The bacterial load on hands before antisepsis (pre-values) is obtained after the preparatory handwash using a diluted soft soap. Next, surgical hand antisepsis protocols are performed. Enrolled participants are randomly divided into four groups of the same size to receive RP or Sorbectol for 1 min (P1), 3 min (P2) or 5 min (P3) in parallel in a first run. The test is repeated in a second, third and fourth run changing the antisepsis roles for each group. A washout period of at least 2 weeks between experimental runs allow for the reconstitution of skin microbiota. All participants complete the four antiseptic procedures at the end of the trial.

The RP group, rub their hands with n-propanol (60% v/v) for 3 min. The test product groups, rub their hands with Sorbectol for 1 or 3 or 5 min. In all cases applying as many 3 ml portions as necessary to keep the hands moist for the selected time. After antisepsis the bacterial load (post-values) is determined using a split-hands model. One hand to assess the bacterial load immediately after treatment (immediate post-values) and the other hand to assess the bacterial load 3 hours later, keeping the hand gloved in the meantime (3-h post-values).

Conditions

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Hand Washing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

clinical trial, randomized, crossover.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants ignore which product is being used in each intervention.

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes