Optimization of Surgical Hand Preparation Using Sorbectol

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Immediate effect assessed immediately after surgical hand antisepsis — 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.]
  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.
• Effect assessed 3-hours after surgical hand antisepsis — The 3-hours effect is a measure determined at the time point 2 which is 3 hours after the immediate effect determination]
  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.

Trial sites (1)

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