Whole body washing to reduce skin-surface bacteria: pilot study in healthy volunteers

ISRCTN	ISRCTN25160191
DOI	https://doi.org/10.1186/ISRCTN25160191
Secondary identifying numbers	N/A

Submission date: 31/03/2010
Registration date: 07/04/2010
Last edited: 31/10/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Judith Tanner
Scientific

Charles Frears Campus
266 London Road
Leicester
LE2 1RQ
United Kingdom

Email	jtanner@dmu.ac.uk

Study information

Study design	Pilot randomised active controlled parallel-group trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
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
Study objectives	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(s)	Faculty of Health and Life Sciences Research Ethics Committee, De Montfort University, 04/02/2010, ref: 584
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2010
Completion date	21/05/2010

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	60 participants spread across 3 groups. 20 participants in each group (pilot study)
Total final enrolment	60
Key inclusion criteria	1. Healthy volunteers from De Montfort University - staff or students 2. Any age and either sex
Key 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
Date of first enrolment	01/03/2010
Date of final enrolment	21/05/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

De Montfort University

Leicester
LE2 1RQ
United Kingdom

Sponsor information

De Montfort University (UK)
University/education

The Gateway
Leicester
LE1 9BH
England
United Kingdom

Phone	+44 (0)116 255 1551
Email	tmoore@dmu.ac.uk
"ROR"	https://ror.org/0312pnr83

Funders

Funder type

Industry

Molnlycke Health Care (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012	31/10/2019	Yes	No

Editorial Notes

31/10/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
05/07/2016: No publications found, verifying study status with principal investigator.