ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000902190p

Ethics application status

Submitted, not yet approved

Date submitted

18/01/2019

Date registered

27/06/2019

Date last updated

27/06/2019

Date data sharing statement initially provided

27/06/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Hyperbaric oxygen therapy for lower limb burns in diabetic patients

Scientific title

Effect of hyperbaric oxygen on wound healing and scar outcome in diabetic patients with lower limb burns

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Diabetes

Burn Injury

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Injuries and Accidents

Burns

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing and scar outcome.

Diabetic patients with lower limb burns who require debridement and skin grafting would be randomised to receive either:
HBOT post-operatively
OR sham HBOT
This treatment of sham treatment would be delivered at Fiona Stanley Hyperbaric medicine department by trained hyperbaric technicians.

These treatments would be delivered daily for 2-4 weeks.
After the treatment or sham treatment, the patient would receive standard care for all wounds.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group would receive exactly the same treatment apart from the dive in the hyperbaric chamber would be a sham dive, not delivering the hyperbaric oxygen

Treatment arm – 111minutes of 140kPa Oxygen filled chamber
Control arm – 111 minutes of 30kPa air filled chamber
Follow up = same for both arms

Control group

Placebo

Outcomes

Primary outcome [1]

Percentage wound healing assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a 3D camera to map the area of the healed/unhealed area of wound to form a ratio.

Primary timepoint: 4 weeks (primary timepoint), 3months, 6 months and 12 months

Timepoint [1]

4 weeks post surgery

Secondary outcome [1]

Scar quality:
Vancouver Scar Scale

Timepoint [1]

6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery

Secondary outcome [2]

Scar quality:
Patient and Observer Assessment scar score

Timepoint [2]

6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery

Secondary outcome [3]

Scar quality:
Dermalab measurements (pigmentation, vascularity, scar thickness and elastography)

Timepoint [3]

6 weeks post-surgery,
3 months post-surgery
6 months post-surgery
1 year post-surgery

Secondary outcome [4]

Quality of life:
SF36

Timepoint [4]

3 months post-surgery
6 months post-surgery
1 year post-surgery

Secondary outcome [5]

Quality of life: Brisbane Burn Scar Impact Profile

Timepoint [5]

3 months post-surgery
6 months post-surgery
1 year post-surgery

Secondary outcome [6]

Quality of life:
Structured interviews - 30 minutes by telephone, one-on-one, audio recorded and transcribed

Timepoint [6]

3 months post-surgery
6 months post-surgery
1 year post-surgery

Eligibility

Key inclusion criteria

Adults 18+ years of age
Burn below knee on one or both legs
First presentation with burn on index limb
Type I or II diabetes mellitus
Able to consent to trial
Fluent in verbal and written English

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Pregnant or lactating women
Patients who fail the pre-hyperbaric treatment ear pressure test for barotrauma and would require tympanostomy tubes (grommets)
Patients who would not pass the screening process for standard hyperbaric treatment (those treated with Bleomycin (increases risk of pulmonary fibrosis); patients with current brain tumours or carbon monoxide poisoning (increased risk of oxygen toxicity) or with existing cataracts (can increase progression)

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)

Sealed opaque envelopes

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

Stratified randomisation using factors of age, gender and ethnicity
Computerised sequence generation using random number generator assignation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

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

Pilot study trial of 30 patients as not enough data known on healing percentage/times of diabetic burn lower limbs with and without hyperbaric oxygen to determine standard deviations
Non-parametric tests used for smaller number of group - Kruksall-Wallis tests

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

2/09/2019

Actual

Date of last participant enrolment

Anticipated

1/09/2020

Actual

Date of last data collection

Anticipated

6/09/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Fiona Wood Foundation

Address [1]

Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6158 WA

Country [1]

Australia

Primary sponsor type

Hospital

Name

Fiona Stanley Hospital

Address

Fiona Stanley Hospital, 11 Robin Warren Drive, Murdoch, 6158 WA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Department of Health WA Human research ethics committee

Ethics committee address [1]

PO Box 8172
 Perth Business Centre
 Perth WA 6849

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/06/2019

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This project aims to see whether hyperbaric oxygen therapy (HBOT) after debridement and skin grafting of a diabetic lower limb burn improves healing.
Diabetic lower limb burns are very common - a recent audit performed in our service revealed 35 such injuries over the past 18 months, 75% of which required debridement and skin grafting. It also identified that these patient stay on average 2.5 times longer in hospital than our normal average length of stay. In addition a third require a second operation and due to poor healing 23% proceeded to some form of amputation.
Hyperbaric oxygen therapy has been used increasingly to assist with healing of complex and chronic wounds, however robust evidence for its use, particularly in burns, is still lacking. At Fiona Stanley Hospital we have a HBOT unit and are the adult tertiary referral service for burn injuries. We therefore propose to perform a double blind randomised controlled trial looking at diabetic lower limb burns which required debridement and skin grafting. All diabetic patients with deep lower limb burns would be considered for the trial and would have debridement, skin grafting and VAC therapy within 72 hours of presentation to our service. Immediately post-operatively they would be randomised to receive either HBOT post-operatively OR sham HBOT. These treatments would be delivered daily for 2-4 weeks. After the treatment or sham treatment, the patient would receive standard care for all wounds.
At 4 weeks the wounds would be assessed by a clinician blinded to treatment to assess the percentage healing of the wound, using a camera to map the area of the healed/unhealed area of wound to form a ratio.
At 3, 6 and 12 months the wounds would be assessed for healing, time in dressings, episodes of breakdown, requirements for secondary surgery and QoL

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Helen Douglas

Address

State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA

Country

Australia

Phone

+61 861522222

Fax

helen.douglas@health.wa.gov.au

Contact person for public queries

Name

Helen Douglas

Address

State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA

Country

Australia

Phone

+61 861522222

Fax

helen.douglas@health.wa.gov.au

Contact person for scientific queries

Name

Helen Douglas

Address

State Adult Burns Unit
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch 6158
WA

Country

Australia

Phone

+61 861522222

Fax

helen.douglas@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified patient data would be considered for sharing on request, but not automatically

When will data be available (start and end dates)?

Beginning 3 months and ending 5 years following main results publication

Available to whom?

Other researchers in the field with methodologically sound proposals whose research may benefit from our de-identified data - at the discretion of study investigators and sponsor

Available for what types of analyses?

Any purpose

How or where can data be obtained?

access subject to approvals by Principal Investigator to be emailed at FSH.BurnResearch@health.wa.gov.au

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.

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