ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000451404

Ethics application status

Approved

Date submitted

20/08/2007

Date registered

3/09/2007

Date last updated

22/02/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Pilot investigation of post burn itch - a randomised control trial

Scientific title

Will those people with partial or full thickness burns have diminished post burn itch using Medilixir and massage in comparison to acqueous creme and massage?

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

ITCH (Investigating the effect of Treatment Creme to Help reduce post burn itch)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burns

Condition category

Condition code

Injuries and Accidents

Burns

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Medilixir is a topical creme which is a combination of bees wax and herbal oils. Patients will apply the Medilixir to the area of their newly healed burn twice daily for two weeks. Following this period they will 'crossover' and use aqueous creme twice daily on their newly healed burn for a further one week. There will be no washout period for this study between crossover as lotions applied topically for the relief of post burn itch are effective for short periods of time only. As cremes will crossover on the commencement of a new calander day there will be 12 hours or more between topical applications and an additional seven days to determine the elevation or decline or any further itch. The massage component of this study involves application of either creme. Each creme will be applied over a 5 to 10 minute period and massaged well into the newly healed skin.

Intervention code [1]

Other interventions

Comparator / control treatment

Aqueous creme - the current standard treatment for post burn itch at the Royal Brisbane and Womens Hospital (RBWH) is currently applied topically to to the area of the patients newly healed burn twice daily until the patient deems this unnecessary (this period varies from days to months depending upon the relief from itch the creme may generate). For the purpose of this trial aqueous creme (as with Medilixir) will be applied twice daily to the newly healed burn. Depending upon group allocation (control or experiment) participants will receive aqueous for 1 week (if in the experiment where they will receive Medilixir for 2 weeks followed by aqueous for 1 week) or 2 weeks (if in the control where they will receive aqueous for the initial two weeks followed by one week of Medilixir creme).

Control group

Active

Outcomes

Primary outcome [1]

Diminished post burn itch as measured by a visual analogue scale (previously validated in other burn itch studies).

Timepoint [1]

Two weeks following application of either aqueous or Medilixir creme itch measures for the control and experimental groups will be statistically compared.

Secondary outcome [1]

Dimished antihistamine use

Timepoint [1]

Two weeks following application of either aqueous or Medilixir creme antihistamine use between control and experimental groups will be statistically compared.

Eligibility

Key inclusion criteria

Patients with partial or full thickness burns to their body surface area or greater. Those able to provide informed consent.

Minimum age

18 Years

Maximum age

110 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Those unable to provide informed consent. Those unable to answer questions accurately given communication difficulties.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Each potential participant will be approached by the research assistant when their burn has healed and aqueous creme treatment would routinely commence. The patients will have the study explained to them (their involvement, the study timeframes, as well as their options to either refuse study inclusion or withdraw from the study). As patients are not aware of what either aqueous creme or Medilixir looks like this will form their blinding. Allocation to this trial will be concealed with the use of sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer random number generator will be used to allocate participants to either group.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/03/2008

Actual

3/03/2008

Date of last participant enrolment

Anticipated

8/08/2008

Actual

18/08/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4006

Funding & Sponsors

Funding source category [1]

University

Name [1]

Queensland University of Technology

Address [1]

Victoria Park Rd
Kelvin Grove
4059

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Royal Brisbane and Womens Hospital Foundation.

Address [2]

RBWH
Herston Rd
Herston
Brisbane

Country [2]

Australia

Primary sponsor type

Hospital

Name

Royal Brisbane and Womens Hospital

Address

Herston Rd
Herston
Brisbane

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Smith and Nephew

Address [1]

Smith & Nephew Pty Limited
Unit 9, 211 Montague Road
West End
Queensland 4101
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RBWH HREC

Ethics committee address [1]

RBWH
Herston Rd
Herston
Brisbane

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/08/2007

Approval date [1]

01/09/2007

Ethics approval number [1]

EC00172

Summary

Brief summary

Between the years 2000 and 2004 approximately 46,611 people were hospitalised in Australia as a result of burn or scald related injury.1 While comorbidities such as infection and psychosocial health alterations are readily described, patients recovering from burn injury frequently experience a post burn itch.2,3 Post burn itch affects up to 80% of the burn population.4 While post burn itch varies in time frame as well as severity, some patients experience severe and debilitating itch disturbing their sleep, activities of daily living as well as their quality of life for months following wound healing.3 Post burn itch treatments, while multimodal, remain consistently ineffective.3 In line with current literature The Royal Brisbane and Women’s Hospital (RBWH) Burns Unit utilises various combinations of antihistamine medications, regular bathing, massage and aqueous crème in their management of post burn itch. Despite these varied interventions and the reputation of the RBWH Burn Unit as a centre of clinical excellence, itch remains the problem here that it is globally. Recent anecdotal evidence from several RBWH burn outpatients, however, suggests Medilixir (a combination of bees wax and herbal oils) to successfully assist in the minimisation of post burn itch. For this small patient cohort the change from aqueous crème to Medilixir markedly reduced their post burn itch. 1. Harrison, J., & Steel, D. (2006). Burns and scalds. Australian Institute of Health and Welfare National Injury Surveillance Unit Briefing, 7, October 2006. 2. Smith, J.S., Smith, K.R., Rainey, S.L., & DelGiorno, J. (2006). The psychology of burn care. Journal of Trauma Nursing, 13(3), pp.105-106. 3. Matheson, J.D., Clayton, J., & Muller, M.J. (2001). The reduction of itch during burn wound healing. Journal of Burn Care and Rehabilitation, 22(1),pp.76-81. 4. Demling, R.H., & DeSanti, L. (2003). Topical Doxepin significantly reduces itching and erythema in the chronically pruritic burn scar. Wounds, 15(6), pp.195-200.

Trial website

Trial related presentations / publications

Lewis, P.A., Wright, K., Webster, A., Steer, M., Rudd, M., Doubrovsky, A., & Gardener, G. (2012). A randomized controlled trial comparing aqueous crème with a beeswax and herbal oil crème in the provision of relief from post-burn pruritis. Journal of Burn Care & Research. 33(4), pp.195-200. 

Savovic, J., & Lewis, P. (2013), A pilot randomised trial of Medilixir cream shows some promising results, but control treatment may have been inappropriate. Focus on Alternative and Complementary Therapies. 18(2), pp.104–106. 

RBWH Health Care Symposium, Brisbane, Australia, 2008. P.A.Lewis, K.Wright, A.Webster, M.Steer, G.Gardner.
“A randomised controlled trial comparing aqueous crème with bees wax crème in the provision of relief from post-burn itch”

32nd Annual Scientific Meeting of the Australian and New Zealand Burns Association, Melbourne, Australia, 2008. P.A.Lewis, K.Wright, A.Webster, M.Steer, R.Cinco, G.Gardner, M.Rudd.
“A randomised controlled trial comparing aqueous crème and bees wax crème in the provision of relief from post-burn itch”

Public notes

Contacts

Principal investigator

Name

A/Prof Peter Lewis

Address

ACU - Nudgee Campus

Country

Australia

Phone

+61 7 3861 6094

Fax

peter.lewis@acu.edu.au

Contact person for public queries

Name

Kay Wright

Address

Royal Brisbane and Womens Hospital - Stuart Pegg Burns Unit
Herston Rd
Herston 4006

Country

Australia

Phone

+61 7 3636 3496

Fax

kay_wright@health.qld.gov.au

Contact person for scientific queries

Name

Peter Lewis

Address

Queensland University or Technology
Kelvin Grove Rd
Kelvin Grove
4059

Country

Australia

Phone

+61 7 3138 3834

Fax

peter.lewis@acu.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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