Optimization of Surgical Hand Preparation Using Sorbectol

Universidad Complutense de Madrid

Status: Enrolling

Conditions: Hand Washing

Treatments: Other: Surgical hand rub with the reference product; n-propanol 60%.; Other: Surgical hand rub with the product P2; Sorbectol for 3 min.; Other: Surgical hand rub with the product P1; Sorbectol for 1 min.; Other: Surgical hand rub with the product P3; Sorbectol for 5 min.

Study type: Interventional

Funder types: Other

Identifiers

NCT06688890

SORBUCM_MP

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 4 patient groups

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

Experimental group

Treatment:

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

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

Experimental group

Treatment:

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 group

Treatment:

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 group

Treatment:

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