Condition category
Infections and Infestations
Date applied
31/03/2010
Date assigned
07/04/2010
Last edited
05/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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)

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/07/2016: No publications found, verifying study status with principal investigator.