Clinical Trial Results:
Hibiscrub EN12791 Testing using current application and 2 new application methods
Summary
|
|
EudraCT number |
2006-005470-41 |
Trial protocol |
GB |
Global end of trial date |
12 Jan 2007
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
29 Nov 2019
|
First version publication date |
29 Nov 2019
|
Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
CTR0028
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Regent Medical
|
||
Sponsor organisation address |
Two Omega Drive, Irlam, United Kingdom, M44 5BJ
|
||
Public contact |
Caroline Scott, Molnlycke Health Care, caroline.scott@molnlycke.com
|
||
Scientific contact |
Suchismita Roy, Molnlycke Health Care, suchismita.roy@molnlycke.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
12 Jan 2007
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
12 Jan 2007
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
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
|
||
Protection of trial subjects |
The product used was a marketed product for use a topical hand wash
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Nov 2006
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 20
|
||
Worldwide total number of subjects |
20
|
||
EEA total number of subjects |
20
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
20
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||||||||
Recruitment
|
||||||||||||||||
Recruitment details |
- | |||||||||||||||
Pre-assignment
|
||||||||||||||||
Screening details |
Aged 18-65, male or female Able to communicate well with the investigator and to comply with the requirements of the entire study Healthy skin on hands without cuts or abrasions | |||||||||||||||
Period 1
|
||||||||||||||||
Period 1 title |
Overall trial (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||
Blinding used |
Single blind | |||||||||||||||
Roles blinded |
Subject | |||||||||||||||
Arms
|
||||||||||||||||
Are arms mutually exclusive |
No
|
|||||||||||||||
Arm title
|
Method 1 | |||||||||||||||
Arm description |
Application as per Manufacturers label instructions | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
PR1
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Hibiscrub
|
|||||||||||||||
Pharmaceutical forms |
Cutaneous solution
|
|||||||||||||||
Routes of administration |
Cutaneous use
|
|||||||||||||||
Dosage and administration details |
5ml applied rubbed for 1 min, rinse, 5ml application rubbed for 2 min, rinse, shake and dry
|
|||||||||||||||
Arm title
|
Method 2 | |||||||||||||||
Arm description |
New Application Method | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
PR1
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Hibiscrub
|
|||||||||||||||
Pharmaceutical forms |
Cutaneous solution
|
|||||||||||||||
Routes of administration |
Cutaneous use
|
|||||||||||||||
Dosage and administration details |
5ml application rubbed for 1 min, rinse
5ml application rubbed for 1 min, rinse
5ml application rubbed for 1 min, rinse, shake and dry
|
|||||||||||||||
Arm title
|
Method 3 | |||||||||||||||
Arm description |
New application method | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
PR1
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
Hibiscrub
|
|||||||||||||||
Pharmaceutical forms |
Cutaneous solution
|
|||||||||||||||
Routes of administration |
Cutaneous use
|
|||||||||||||||
Dosage and administration details |
Apply 5 mls of product and scrub for 1 minute, wash and rinse
Apply 5 mls of product and scrub for 2 minute, wash and rinse
Apply 5 mls of product and scrub for 2 minute, wash and rinse
|
|||||||||||||||
Arm title
|
Reference | |||||||||||||||
Arm description |
As specified by the EN12791:2005 N-propanol with set instructions as the ideal efficacy results | |||||||||||||||
Arm type |
Reference | |||||||||||||||
Investigational medicinal product name |
PR2
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
N-Propanol
|
|||||||||||||||
Pharmaceutical forms |
Cutaneous liquid
|
|||||||||||||||
Routes of administration |
Cutaneous use
|
|||||||||||||||
Dosage and administration details |
3 min rub
|
|||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Method 1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Application as per Manufacturers label instructions | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Method 2
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
New Application Method | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Method 3
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
New application method | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Reference
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
As specified by the EN12791:2005 N-propanol with set instructions as the ideal efficacy results | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Method 1
|
||
Reporting group description |
Application as per Manufacturers label instructions | ||
Reporting group title |
Method 2
|
||
Reporting group description |
New Application Method | ||
Reporting group title |
Method 3
|
||
Reporting group description |
New application method | ||
Reporting group title |
Reference
|
||
Reporting group description |
As specified by the EN12791:2005 N-propanol with set instructions as the ideal efficacy results |
|
|||||||||||||||||||||
End point title |
Comparison of bacterial efficacy of each arm to reference product - immediate | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Bacterial counts taken immediately after use and 3 hours after use and compared to counts down immediately after use
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Reference V each method (Immediate) | ||||||||||||||||||||
Comparison groups |
Method 2 v Method 1 v Method 3 v Reference
|
||||||||||||||||||||
Number of subjects included in analysis |
80
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
> 14 | ||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||||
Confidence interval |
|
|||||||||||||||||||||
End point title |
Comparison of bacterial reduction factor for each application method and reference - 3 hour | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
3 hours after application
|
||||||||||||||||||||
|
|||||||||||||||||||||
Statistical analysis title |
Reference V each method (3 hour) | ||||||||||||||||||||
Comparison groups |
Method 1 v Method 2 v Method 3 v Reference
|
||||||||||||||||||||
Number of subjects included in analysis |
80
|
||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||
P-value |
> 24 | ||||||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||||||
Confidence interval |
|
|||||||||||
Adverse events information [1]
|
|||||||||||
Timeframe for reporting adverse events |
Subjects were monitored for the length of the trial - 4 weeks
|
||||||||||
Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
|
|||||||||||
Dictionary name |
MedDRA | ||||||||||
Dictionary version |
9.1
|
||||||||||
Reporting groups
|
|||||||||||
Reporting group title |
Overall Trial
|
||||||||||
Reporting group description |
20 subjects enrolled and randomized to complete all 4 arms of the study over a 4 week period | ||||||||||
|
|||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
|
|||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There was no non-serious AE reported due to the nature of the testing to a set standard and healthy volunteers taking part |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |