Optimization of Surgical Hand Preparation Using Sorbectol

Официальное название

Optimization of the Effectiveness of the Hydroalcoholic Solution of 3% Chlorhexidine Digluconate and 0.3% Potassium Sorbate in 70% Ethanol, Sorbectol, in Surgical Hand Preparation According to the UNE-EN 12791 Standard

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Immediate effect assessed immediately after surgical hand antisepsis [Срок оценки: 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 [Срок оценки: The 3-hours effect is a measure determined at the time point 2 which is 3 hours after the immediate effect determination]]

Вторичные конечные точки (3)

• Bacterial counts preexisting on the hands before surgical hand antisepsis. Pre-values. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 3-hours post-value is a measure determined at the time point 2, which is 3 hours after the immediate post-value determination.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universidad Complutense de Madrid — Madrid

Публикации

• 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
• 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

Идентификаторы

NCT: NCT06688890 · SORBUCM_MP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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