Contact information
Type
Scientific
Primary contact
Prof Judith Tanner
ORCID ID
Contact details
Charles Frears Campus
266 London Road
Leicester
LE2 1RQ
United Kingdom
-
jtanner@dmu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial of three body washing products to reduce bacterial colony forming units on skin: a pilot study in healthy volunteers
Acronym
Study hypothesis
What is the difference in the reduction of colony forming units on skin between three body washing products, using pre-intervention and three post intervention time points?
This is a pilot study to investigate which product is most effective at reducing bacteria on skin. Skin bacteria can cause surgical site infections.
Ethics approval
Faculty of Health and Life Sciences Research Ethics Committee, De Montfort University, 04/02/2010, ref: 584
Study design
Pilot randomised active controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Surgical site infections
Intervention
Participants randomised to 1 of 3 groups using random number tables and sequentially numbered sealed envelopes
1. Group 1 Control: Plain soap and plain shampoo
Participants shower daily for two days using the following instructions -
Enter shower, ensure body and hair are wet. Apply 25mls soap to body, rinse and repeat using another 25mls. Wash hair. Rinse thoroughly. Dry with a clean towel.
2. Group 2 Intervention: Hibiscrub® Plus
Participants shower daily for two days following manufacturers instructions -
Enter shower, ensure body and hair are wet. Apply 25mls Hibiscrub® Plus to body, rinse and repeat using another 25mls. Wash hair. Rinse thoroughly. Dry with a clean towel.
3. Group 3 Intervention: Octenisan®
Participants shower daily for five days following manufacturers instructions -
Enter shower, ensure body and hair are wet. Apply Octenisan® to a damp cloth and apply to body. Leave for 3 minutes before rinsing thoroughly. Wash hair with Octenisan® on day 2 and day 4. Dry with a clean towel.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Colony forming units from swabs taken from nose, armpit and groin pre-intervention and post intervention at 0 hours, 4 hours and 6 hours.
Secondary outcome measures
None
Overall trial start date
01/03/2010
Overall trial end date
21/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy volunteers from De Montfort University - staff or students
2. Any age and either sex
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
60 participants spread across 3 groups. 20 participants in each group (pilot study)
Total final enrolment
60
Participant exclusion criteria
1. Allergic to soaps, Hibiscrub® Plus or Octenisan®
2. Has an open wound
3. Currently taking antibiotics or has taken antibiotics in the previous week
4. Has a respiratory infection
5. Has a skin infection
6. Wears jewellery in nose
7. Wears moisturiser, body lotion or any other antiseptic skin product
Recruitment start date
01/03/2010
Recruitment end date
21/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
De Montfort University
Leicester
LE2 1RQ
United Kingdom
Sponsor information
Organisation
De Montfort University (UK)
Sponsor details
The Gateway
Leicester
LE1 9BH
United Kingdom
+44 (0)116 255 1551
tmoore@dmu.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Molnlycke Health Care (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3307127 (added 31/10/2019)