Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 288596 0
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 2280 0
Condition category
Condition code
Injuries and Accidents 2372 2372 0 0
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] 1990 0
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] 3270 0
Diminished post burn itch as measured by a visual analogue scale (previously validated in other burn itch studies).
Timepoint [1] 3270 0
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] 5455 0
Dimished antihistamine use
Timepoint [1] 5455 0
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?
No
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
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 377 0
4006

Funding & Sponsors
Funding source category [1] 2528 0
University
Name [1] 2528 0
Queensland University of Technology
Country [1] 2528 0
Australia
Funding source category [2] 3142 0
Hospital
Name [2] 3142 0
Royal Brisbane and Womens Hospital Foundation.
Country [2] 3142 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
Herston Rd
Herston
Brisbane
Country
Australia
Secondary sponsor category [1] 2290 0
Commercial sector/Industry
Name [1] 2290 0
Smith and Nephew
Address [1] 2290 0
Smith & Nephew Pty Limited
Unit 9, 211 Montague Road
West End
Queensland 4101
Australia
Country [1] 2290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4443 0
RBWH HREC
Ethics committee address [1] 4443 0
RBWH
Herston Rd
Herston
Brisbane
Ethics committee country [1] 4443 0
Australia
Date submitted for ethics approval [1] 4443 0
22/08/2007
Approval date [1] 4443 0
01/09/2007
Ethics approval number [1] 4443 0
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 27994 0
A/Prof Peter Lewis
Address 27994 0
ACU - Nudgee Campus
Country 27994 0
Australia
Phone 27994 0
+61 7 3861 6094
Fax 27994 0
Email 27994 0
[email protected]
Contact person for public queries
Name 11151 0
A/Prof Kay Wright
Address 11151 0
Royal Brisbane and Womens Hospital - Stuart Pegg Burns Unit
Herston Rd
Herston 4006
Country 11151 0
Australia
Phone 11151 0
+61 7 3636 3496
Fax 11151 0
Email 11151 0
[email protected]
Contact person for scientific queries
Name 2079 0
A/Prof Peter Lewis
Address 2079 0
Queensland University or Technology
Kelvin Grove Rd
Kelvin Grove
4059
Country 2079 0
Australia
Phone 2079 0
+61 7 3138 3834
Fax 2079 0
Email 2079 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.