Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000520730
Ethics application status
Approved
Date submitted
23/03/2022
Date registered
1/04/2022
Date last updated
3/03/2023
Date data sharing statement initially provided
1/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study assessing the feasibility of NexoBrid versus the current standard of care of isolated upper limb burns: A solution to “the perfect crime”?
Scientific title
A pilot study assessing the feasibility of NexoBrid versus the current standard of care of isolated upper limb burns: A solution to “the perfect crime”?
Secondary ID [1] 306496 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Burns 325360 0
Condition category
Condition code
Surgery 322744 322744 0 0
Other surgery
Injuries and Accidents 323169 323169 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NexoBrid is a bromelain-based enzymatic debriding agent that is well established in many European burn centres. It is a lyophilised, partially purified, proteolytic protein mixture with increased specific enzyme activity derived from Bromelain raw material extracted from pineapple stems.
In the pilot study, NexoBrid will be administered to mid- to deep dermal and full thickness burns of the upper limb.
Nexobrid will be administered topically in a single session by a specialist Burns Surgeon for a total of 4 hours with an occlusive dressing.
Eligible patients will be consecutively allocated into either the NexoBrid or SOC group.
Intervention code [1] 323175 0
Treatment: Other
Comparator / control treatment
Early surgical debridement followed by autologous skin grafting is considered to be the standard of care (SOC) internationally for the treatment of burn injury as it prevents early complications and minimises hypertrophic scarring.
Control group
Active

Outcomes
Primary outcome [1] 330829 0
Length of stay (LOS) measured as number of days as an inpatient for treatment of their burn. The data will be collected based on hospital records of admission and discharge dates.
Timepoint [1] 330829 0
Length of admission or, day of discharge.
Secondary outcome [1] 407758 0
Pain assessed by Numeric Pain Rating Scale (NPRS)
Timepoint [1] 407758 0
Nexobrid group:
1. Pre-NexoBrid (baseline)
2. During debridement
3. Immediately after block has worn off
4. 24 hours post-debridement
SOC group:
1. Pre-operative (baseline)
2. In PACU
3. 24 hours post-operative
Secondary outcome [2] 407759 0
Patient Experience measured by a Short Assessment of Patient Satisfaction (SAPS) survey
Timepoint [2] 407759 0
Nexobrid group & SOC group:
1. Day of discharge
Secondary outcome [3] 407760 0
Functionality of the upper limb measured by grip strength using the JAMAR dynamometer
Timepoint [3] 407760 0
Nexobrid group:
1. Pre-NexoBrid (baseline)
2. Day of discharge
SOC group:
1. Pre-operative (baseline)
2. Day of discharge

Eligibility
Key inclusion criteria
- Age 18 years or older
- Patient consent/ willingness to participate and comply with study requirements
- Thermal burn (flame, scald, contact)
- TBSA less than 10%
- Burn assessed to require surgical debridement
- Burn depth: mid- to deep dermal and full thickness
- Anatomical location of the burn isolated to the upper limb
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age less than 18 years
- Patient decline to consent or unwillingness to participate and comply with study requirements
- Chemical, crush or electrical burns or a penetrating burn wound where foreign materials or vital structures are or could become exposed during treatment
- TBSA greater than 10%
- NexoBrid contraindications based on manufacturer guidelines:
- History of and/or known hypersensitivity/allergy to any of the following: pineapples, bromelain, papaya, papain
- Smoke inhalation
- Pregnant and/or breastfeeding/nursing
- Compartment syndrome present
- Coagulopathies, recent anticoagulant or antiplatelet medication
- Pretreatment with betadine (astringent) or silver sulfadiazine (flamazine) (interference from silver)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is pilot study involving minimal numbers per arm. Statistical analysis will be performed using the SPSS software program (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be used to summarise patient characteristics. Continuous data will be expressed as a median and range while discrete data will be reported as frequency and percentage.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21999 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 37101 0
4029 - Herston
Recruitment postcode(s) [2] 37102 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 311065 0
Charities/Societies/Foundations
Name [1] 311065 0
RBWH Foundation Burns Research Grant 2022
Country [1] 311065 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Royal Brisbane and Women's Hospital
Butterfield Street
Herston, QLD
4029
Country
Australia
Secondary sponsor category [1] 312096 0
None
Name [1] 312096 0
N/A
Address [1] 312096 0
N/A
Country [1] 312096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310406 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 310406 0
Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 310406 0
Australia
Date submitted for ethics approval [1] 310406 0
01/03/2021
Approval date [1] 310406 0
12/03/2021
Ethics approval number [1] 310406 0
HREC/2021/QRBW/66062

Summary
Brief summary
In this pilot study, NexoBrid will be administered and its effectiveness will be assessed compared to the current surgical standard of care (SOC). This study will recruit 10 patients with upper limb burns treated with NexoBrid compared to 10 patients with upper limb burns receiving the SOC. It is hypothesised that the use of NexoBrid on acute thermal upper limb burns will reduce the patient length of stay in hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117550 0
Dr Carl Lisec
Address 117550 0
Royal Brisbane Clinical Unit, Level 9 Health Sciences Building,
Royal Brisbane and Women's Hospital, Butterfield Street, HERSTON, QLD, 4006
Country 117550 0
Australia
Phone 117550 0
+61 403432087
Fax 117550 0
Email 117550 0
carl.lisec@health.qld.gov.au
Contact person for public queries
Name 117551 0
Dr Carl Lisec
Address 117551 0
Royal Brisbane Clinical Unit, Level 9 Health Sciences Building,
Royal Brisbane and Women's Hospital, Butterfield Street, HERSTON, QLD, 4006
Country 117551 0
Australia
Phone 117551 0
+61 403432087
Fax 117551 0
Email 117551 0
carl.lisec@health.qld.gov.au
Contact person for scientific queries
Name 117552 0
Dr Carl Lisec
Address 117552 0
Royal Brisbane Clinical Unit, Level 9 Health Sciences Building,
Royal Brisbane and Women's Hospital, Butterfield Street, HERSTON, QLD, 4006
Country 117552 0
Australia
Phone 117552 0
+61 403432087
Fax 117552 0
Email 117552 0
carl.lisec@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Providing IPD will not change the health plan for the patient. All data will be compiled after recruitment and analysed. It is anticipated that the results of this study will be eligible for publication in a peer-reviewed medical journal and presented at relevant state, national or international conferences.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15475Study protocol  amelia.perri@health.qld.gov.au
15476Informed consent form  amelia.perri@health.qld.gov.au



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.