This trial will be carried out on healthy volunteers. Hibiscrub is a 4% chlorhexidine glucnate based pre-operative surgical hand disinfectant. Volunteers are going to use the product in three different application methods and each method is going to be evaluated compared to the reference product as specified in the EN 12791 protocol.
Conditions
Interventions
Trade Name: Hibiscrub
Product Name: Hibiscrub
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: Chlorhexidine gluconate
CAS Num
Sponsors
Regent Medical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria a) Aged 18 to 65, male or female b) Able to communicate well with the investigator and to comply with the requirements of the entire study. c) Provision of written informed consent to participate as shown by a witnessed signature on the volunteer consent form. d) Healthy skin on hands without cuts or abrasions and with short and clean finger nails. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria a) Those that are pregnant or breast feeding. b) Those suffering from any active skin disorders. c) Those taking medications which in the opinion of the Principal Investigator may affect test results e.g. Antibiotics and anti-histamines d) Those suffering from any medical condition which, in the opinion of the Principal Investigator, will automatically exclude them from participating in the study. e) Those who have participated in a similar study within the previous 3 months. f) Administration of any investigational drug within the previous 3 months (or within the previous 4 months if drug was a new chemical entity). g) Known sensitivity to soaps, detergents, chlorhexidine or glove material.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to assess the suitability of a hand disinfectant product for surgical hand disinfection. The study will evaluate the hand disinfectant against a reference standard. Primary Endpoints- 1. Immediate effect - Reduction of the release of skin flora from the hands as assessed immediately after surgical hand disinfection. 2. 3-hour effect – Reduction of the release of skin flora from the hands as assessed after wearing a surgical glove for 3 h following surgical hand disinfection ; Secondary Objective: Sustained effect – 3-hour effect of the product significantly larger than that of a reference disinfection procedure with Propan-1-ol (60% (volume concentration) ; Primary end point(s): Primary Endpoints 1. Immediate effect - Reduction of the release of skin flora from the hands as assessed immediately after surgical hand disinfection. 2. Three hour effect – Reduction of the release of skin flora from the hands as assessed after wearing a surgical glove for 3 h following surgical hand disinfection | — |
Countries
United Kingdom
Outcome results
None listed