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

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN25160191
• Date of registration: 07/04/2010
• Primary sponsor: De Montfort University (UK)
• Public title: Whole body washing to reduce skin-surface bacteria: pilot study in healthy volunteers N/A
• 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
• Date of first enrolment: Mar 1 2010
• Target sample size: 60 participants spread across 3 groups. 20 participants in each group (pilot study)
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN25160191
• Study type: Interventional
• Study design: Pilot randomised active controlled parallel group trial

Countries of recruitment

United Kingdom

Contacts

• Name: Judith Tanner

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy volunteers from De Montfort University - staff or students
2. Any age and either sex
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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Surgical site infections

Intervention(s)

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.

Primary Outcome(s)

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(s)

None

Secondary ID(s)

N/A

Source(s) of Monetary Support

Molnlycke Health Care (UK)

Secondary Sponsor(s)

N/A