Optimizing surgical hand preparation with Sorbectol
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
NA · Universidad Complutense de Madrid · NCT06688890
This study is testing how different application times of a hand sanitizer called Sorbectol can improve hand cleanliness for surgery by comparing the amount of bacteria on hands before and after using it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06688890 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the effectiveness of Sorbectol, a hydroalcoholic solution, in surgical hand preparation by testing different application times of 1, 3, and 5 minutes. It employs a randomized, Latin-square crossover design involving at least 23 healthy volunteers to compare the bacterial load on hands before and after antisepsis. Participants will undergo a preparatory handwash followed by antisepsis protocols, with the effectiveness measured against a reference product according to European standards. The study will assess both immediate and prolonged effects of the antiseptic application.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals with intact skin and short fingernails who have not used antibacterial agents or received antibiotics recently.
Not a fit: Patients with known systemic pathologies, cognitive or motor limitations, or allergies to the study solutions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical hand hygiene practices, reducing infection rates in surgical settings.
How similar studies have performed: Previous studies have shown positive results with Sorbectol, indicating potential for success in this optimization approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madrid
- Universidad Complutense de Madrid — Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: PARRA — UNIVERSIDAD COMPLUTENSE MADRID
- Study coordinator: PARRA
- Email: mariadelmar.parra@ucm.es
- Phone: +34916500390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hand Washing, Sorbectol, bacterial load, inmediate effect, prolongated effect