Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000401651
Ethics application status
Approved
Date submitted
31/03/2014
Date registered
14/04/2014
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the necessity for physiotherapy intervention for patients with isolated hand/forearm burns treated conservatively or with Biobrane.
Scientific title
The effect of physiotherapy intervention on hand range of motion and function for patients with isolated hand/forearm burns that are able to be treated conservatively or with Biobrane.
Secondary ID [1] 284362 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Isolated hand/forearm burns. 291523 0
Burns. 291524 0
Condition category
Condition code
Injuries and Accidents 291894 291894 0 0
Burns
Physical Medicine / Rehabilitation 291895 291895 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual Treatment Group
Participants allocated to the Usual Treatment Group will receive physiotherapy intervention as per usual practice (lasting approximately 15-30 minutes per day). This will comprise:
Assessment, education, provision and supervision of exercises for the non-affected joints in the affected limb on the first day of admission (conservatively managed) or first post-operative day (Biobrane).
Daily provision, supervision and assistance during hospital admission of range of motion exercises for the affected joints once cleared for movement by the burns surgeon (usually day 1 for conservatively managed patients and day 2 or 3 for Biobrane managed patients).
Provision of a patient education pamphlet detailing these exercises.
Assessment regarding the need for, and fitting if required, of an off-the-shelf compression glove.
Assessment regarding the need for, and intervention if required, scar management.
Assessment and intervention as deemed necessary by the treating physiotherapist following hospital discharge, coinciding, when possible, for times when the patient returns to Burns Outpatients (located in the Burns Unit) for dressing changes.
Hospital discharge usually occurs on day 3 of admission or day 3 post-operatively. Patients usually return for assessment and dressing changes twice a week until the burn is healed (conservatively managed) or the Biobrane has been removed and the burn is healed. Duration of follow-up in Burns Outpatients is until the burn is healed and/or full hand function has been achieved, which usually ranges from 10 days to 4 weeks.
No Treatment Group
Participants allocated to the No Treatment Group will not receive any physiotherapy intervention.
All participants, irrespective of their allocated group, will receive medical, nursing and allied health interventions (apart from physiotherapy) as per usual practice.
Intervention code [1] 289091 0
Rehabilitation
Comparator / control treatment
Participants allocated to the No Treatment Group will not receive any physiotherapy intervention.
Control group
Active

Outcomes
Primary outcome [1] 291815 0
Michigan Hand Questionnaire. It has six scales (overall hand function, activities of daily living, work performance, pain, aesthetics, and patient satisfaction with hand function), with an optional extra scale evaluating the ability to undertake two-handed activities of daily living.
Timepoint [1] 291815 0
Baseline, weeks 1, 2, 4 and 12 post-admission or application of Biobrane.
Secondary outcome [1] 307602 0
Active hand and wrist range of motion. Active hand range of motion will be measured using a finger goniometer, with the patient simultaneously flexing all finger joints maximally. The sum of flexion at all joints (metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints) less the sum of any extension deficit at these joints will be added to give total active motion. This approach gives one functional range of motion for each digit (not including the thumb). A mean total active motion will then be calculated for the affected hand and categorised as 1 = poor, <180 degrees; 2 = good, 180–219 degrees; 3 = excellent, 220–259 degrees; 4 = normal, 260 degrees (Kowalske et al 2007). Total active motion has been used extensively in studies evaluating outcome after hand injury, including burn injury, and is quick and easy to use (Johnson et al 1980; Holavanahalli et al 2007; Williams et al 2012).
Active wrist range of motion (flexion and extension) will be measured using a goniometer in positions recommended by the American Society of Hand Therapists (Adams et al 1992).
Timepoint [1] 307602 0
Weeks 1, 2 and 4 post-admission or application of Biobrane.
Secondary outcome [2] 307603 0
Grip strength. Grip strength will be used as a global assessment of hand strength and measured with a calibrated Jamar dynamometer (JA Preston Corporation, Jackson, MI) on setting two to ensure maximal grip strength as per the American Society of Hand Therapist guidelines (Firrell 1996), with a single maximal attempt recorded (Coldham et al 2006).
Timepoint [2] 307603 0
Weeks 1, 2 and 4 post-admission or application of Biobrane.

Eligibility
Key inclusion criteria
Admitted to the Royal Adelaide Adult Burns Service for management of an isolated unilateral hand/forearm burn (i.e. affecting the hand alone or affecting the hand and extending into the distal 1/3 of the forearm) that is able to be managed conservatively or with Biobrane only.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged less than 18 years.
Refuse consent.
Unable to understand English.
Other major injuries at admission to hospital (e.g. major bony fracture) or a pre-existing condition (e.g. tetraplegia, paraplegia) that might adversely affect outcome.
Unable to return to the Royal Adelaide Hospital for any follow-up appointments.
Received their burn injury in circumstances that were considered so traumatic (e.g. self-inflicted burn injury or where another person had died) that a request to consider participating in the study would be inappropriate.

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)
Patients who meet the eligibility criteria will be individually approached regarding participation by one of the investigators who will explain the study’s aims and format. Potential participants will be provided with a written information sheet. Voluntary participation, confidentiality and anonymity will be emphasised and informed written consent obtained. The information sheet specifically states that participants can withdraw from the study at any time without compromising their care.
Following consent, participants will be randomly allocated to a usual treatment or no treatment group using randomly permuted blocks. Group allocation will be revealed by an independent staff member located in the Physiotherapy Department, Royal Adelaide Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was generated by an independent statistician using the ralloc command in Stata version 13 and stratifying for medical management (i.e. conservative or Biobrane).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The power calculation has been determined using the primary outcome of this study, namely the Michigan Hand Outcomes Questionnaire, which was found to be the most sensitive of the outcome measures used in our previous study of patients with isolated hand burns (Williams et al 2012). After consideration, we based the power calculation on total score Michigan Hand Questionnaire data as we believe this best reflects overall hand outcome, even though there are no data published regarding the minimal clinically important difference in total Michigan Hand Questionnaire score. Whilst there are data concerning the minimal clinically important difference in the hand function domain of the Michigan Hand Questionnaire, we believe that the other domains of the Michigan Hand Questionnaire (e.g. pain, aesthetics) are important in a burn injury population, hence the total Michigan Hand Questionnaire score is more appropriate for sample size calculation. Based on data from our earlier work (Williams et al 2012), it was calculated that a sample size of 25 participants per group would be able to detect a difference of 15 points (75 vs 60 points) at two weeks between groups, based on a Type 1 error of 0.05, a Type 2 error of 0.20 (statistical power of 80%) and a standard deviation of 19. We believe that a difference of 15 points in total Michigan Hand Questionnaire score will be clinically important based on our earlier data where, at 2 weeks, means of 70, 79 and 38 points were seen for the conservative, Biobrane and split skin graft groups respectively (Williams et al 2012). Furthermore, a 15 point difference in score resulted in a sample size that was deemed to be achievable within a reasonable time frame. In order to compensate for loss to follow-up, a sample size of 30 participants per group will be sought.
Raw data will be entered onto purpose designed forms and transferred onto an Excel spreadsheet. Data will be collected on the number of patients screened for eligibility and the reasons for refused consent from otherwise eligible participants. Baseline characteristics of the randomised groups will be reported using descriptive statistics. Michigan Hand Questionnaire, hand and wrist range of motion and grip strength will be compared between groups over time using linear mixed effects models. For continuous outcomes, differences between the groups will be reported as mean differences and 95% confidence intervals for binary outcomes, and rate ratios and 95% confidence intervals. Patients’ ratings of satisfaction with their management will be compared between groups using the independent t test. Analyses will be performed on an intention-to-treat basis. Medical management (i.e. conservative or Biobrane) will be taken into consideration with analyses. Probability values of less than 0.05 will be considered significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/05/2014
Actual
14/07/2014
Date of last participant enrolment
Anticipated
31/07/2017
Actual
8/11/2016
Date of last data collection
Anticipated
8/02/2017
Actual
Sample size
Target
60
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2277 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7952 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289003 0
Self funded/Unfunded
Name [1] 289003 0
No specific funding.
Country [1] 289003 0
Primary sponsor type
Individual
Name
Kathy Stiller
Address
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 287681 0
None
Name [1] 287681 0
Address [1] 287681 0
Country [1] 287681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290812 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 290812 0
Ethics committee country [1] 290812 0
Australia
Date submitted for ethics approval [1] 290812 0
Approval date [1] 290812 0
19/02/2014
Ethics approval number [1] 290812 0
131218

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47370 0
Mr Brad Schmitt
Address 47370 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 47370 0
Australia
Phone 47370 0
61 8 82225334
Fax 47370 0
61 8 82224279
Email 47370 0
[email protected]
Contact person for public queries
Name 47371 0
Kathy Stiller
Address 47371 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 47371 0
Australia
Phone 47371 0
61 8 82225334
Fax 47371 0
61 8 82224279
Email 47371 0
[email protected]
Contact person for scientific queries
Name 47372 0
Kathy Stiller
Address 47372 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 47372 0
Australia
Phone 47372 0
61 8 82225334
Fax 47372 0
61 8 82224279
Email 47372 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
SourceTitleYear of PublicationDOI
EmbaseThe necessity for hand therapy interventions for patients with partial thickness isolated hand/forearm burns: A randomized controlled pilot trial.2018https://dx.doi.org/10.1016/j.burnso.2018.09.001
N.B. These documents automatically identified may not have been verified by the study sponsor.