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Trial registered on ANZCTR


Registration number
ACTRN12617000414314
Ethics application status
Approved
Date submitted
15/03/2017
Date registered
22/03/2017
Date last updated
28/07/2024
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial comparing two new types of nerve repair (Neurawrap and Neuragen) to the conventional type of nerve repair among patients with finger nerve injury.
Scientific title
Effectiveness of direct digital neurorrhaphy; direct digital neurorrhaphy within a collagen nerve wrap; and short gap neurorrhaphy using a collagen conduit on sensibility at one year following digital nerve laceration: a randomised trial.
Secondary ID [1] 291462 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Digital nerve laceration
 302502 0
Condition category
Condition code
Injuries and Accidents 302058 302058 0 0
Other injuries and accidents
Surgery 302059 302059 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo a surgical procedure by a hand surgeon in an operating theatre to repair a lacerated nerve.

Arm 1. Direct digital neurorrhaphy within a collagen nerve wrap (Neurawrap). In this procedure the nerve laceration will be identified during surgery and then repaired using microsurgical suturing. In addition the nerve wrap will be placed around the repair site to protect the repair site during healing.
Arm 2. Short gap neurorrhaphy using a collagen conduit (Neuragen). In this procedure the nerve laceration will be identified during surgery and then the 2 ends of the severed nerve are secured inside the nerve conduit intentionally leaving a 2mm gap between the nerve ends within the conduit. This is performed using similar microsurgical techniques as Arm 1.

Both procedures would take approximately 60 minutes to perform.
Intervention code [1] 297515 0
Treatment: Surgery
Intervention code [2] 297527 0
Treatment: Devices
Comparator / control treatment
The control group patients will also undergo a surgical procedure by a hand surgeon in an operating theatre to repair a lacerated nerve.

They will undergo a Direct digital neurorrhaphy (with no conduit or nerve wrap).
Control group
Active

Outcomes
Primary outcome [1] 301490 0
Touch/pressure threshold
Timepoint [1] 301490 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [1] 332827 0
Static two point discrimination
Timepoint [1] 332827 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [2] 332828 0
Moving two point discrimination
Timepoint [2] 332828 0
2 week, 6 weeks, 3 months, 6 months and 1 year post surgery
Secondary outcome [3] 332829 0
Pain right now, worst pain over past 2 weeks, least pain over past 2 weeks and average pain over past 2 weeks.
Measured using a 100mm visual analogue scale, with 0mm representing no pain and 100mm representing pain as bad as it could be.
Timepoint [3] 332829 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [4] 332830 0
Cold intolerance measured using a likert scale. The participant will be provided with a definition of cold intolerance, and asked to indicate their current cold intolerance intensity and this will be converted to an ordinal score (none/minor = 3, moderate = 2, disturbing = 1, and hinders function = 0).
Timepoint [4] 332830 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [5] 332831 0
Hyperaesthesia measured using a likert scale. The participant will be provided with a definition of hyperaesthesia, and asked to indicate their current hyperaesthesia intensity and this will be converted to an ordinal score (none/minor = 3, moderate = 2, disturbing = 1, and hinders function = 0).
Timepoint [5] 332831 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [6] 332832 0
Total active range of motion for the injured digit will be calculated as the difference between composite flexion and composite loss of extension (ASSH, 1990) with any hyperextension (beyond 0 deg) denoted as 0 deg for the purpose of the calculation. Measurements will be taken using dorsal placement of a hand-held finger goniometer (Rolyan, Patterson Medical Holdings Inc, Bolingbrook, Illinois USA) and reported in deg, with the shoulder, elbow and wrist positioning standardised..
Timepoint [6] 332832 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [7] 332833 0
Overall recovery will be measured using the Global Estimation of Recover (GER) on a 100mm visual analogue scale with 0mm representing no impact and 100mm representing maximal impact.
Participant will be asked to place a vertical mark on the line to estimate the impact of the nerve injury on activities of daily living.
Timepoint [7] 332833 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery
Secondary outcome [8] 332834 0
Participation in work or usual roles will be measured via direct questioning. Participants will be questioned as to whether they have returned to their work or usual role/s and, if so, whether they are undertaking their full duties or modified duties.
Timepoint [8] 332834 0
2 weeks, 6 weeks, 3 months, 6 months, 1 year post surgery

Eligibility
Key inclusion criteria
Age between 18 to 65yo
Male or Female
Treated within 14 days of injury.
Laceration to digital nerve where gap closure can be achieved by flexion of the extremity and the nerve can be held together by a single 9-0 nylon suture Lacerations from proximal end of A1 pulley to trifurcation of nerve distally amenable to primary repair under minimal tension
Patients with associated injuries such as tendon and/or artery injury Signed informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with nerve injuries at more than one level Communication problems due to language or severe psychiatric issues Nerve gaps requiring bridging with grafts or where the nerve cannot be held together by a single 9-0 nylon suture
Known allergy to bovine derived products
Disorders known to affect the peripheral nervous system (PNS) such as diabetes mellitus, chronic heavy alcohol use or toxic nerve lesions
Associated fracture or amputation
Receiving immunosuppressive or antineoplastic agents within 7 days of the study Actively infected wound
Uncooperative or unsuitable for completion of the study

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)
A suitable subject requiring surgical repair of their nerve injury and who have also given consent to a part of the study will be randomised using sealed opaque envelopes in the operating theatre at the time of surgery. The person recruiting the patient into the study is unaware of which group the patient will be in at the time of surgery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of allocation will be computer generated using “Research Randomiser” (Urbaniak, G.C, & Plous, S. (2013). Research Randomizer (version 4.0) [Computer software]. Retrieved on May 19, 2016, from http://www.randomizer.org/) by a member of the research team who is not involved in recruitment. This allocation will be concealed in numbered, sealed, opaque envelopes. These envelopes will be numbered and opened in sequential order and kept safe in a locked cabinet in theatre, only to be accessed by the operating consultant/registrar when the patient who has consented to be part of the study is on that day’ s theatre list.
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

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
27/03/2017
Actual
28/03/2017
Date of last participant enrolment
Anticipated
Actual
14/12/2022
Date of last data collection
Anticipated
28/08/2023
Actual
Sample size
Target
150
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7688 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 15606 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 295932 0
Charities/Societies/Foundations
Name [1] 295932 0
Sydney Hospital Hand Foundation
Country [1] 295932 0
Australia
Primary sponsor type
Individual
Name
John Tawfik
Address
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 294806 0
Individual
Name [1] 294806 0
Lauren Miller
Address [1] 294806 0
The Palms Hand Therapy,
4/75 Railway St, Mudgeeraba, QLD 4213
Country [1] 294806 0
Australia
Secondary sponsor category [2] 294823 0
Individual
Name [2] 294823 0
Timothy CB Heath
Address [2] 294823 0
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country [2] 294823 0
Australia
Secondary sponsor category [3] 294824 0
Individual
Name [3] 294824 0
Anand K Deva
Address [3] 294824 0
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country [3] 294824 0
Australia
Other collaborator category [1] 279482 0
Individual
Name [1] 279482 0
Elaine Leahy
Address [1] 279482 0
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country [1] 279482 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297209 0
SESLHD HREC
Ethics committee address [1] 297209 0
Ethics committee country [1] 297209 0
Australia
Date submitted for ethics approval [1] 297209 0
01/04/2016
Approval date [1] 297209 0
30/06/2016
Ethics approval number [1] 297209 0
2019/ETH10272

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

Contacts
Principal investigator
Name 73350 0
Dr John Tawfik
Address 73350 0
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country 73350 0
Australia
Phone 73350 0
+61 2 9382 7350
Fax 73350 0
Email 73350 0
john@tawfik.com.au
Contact person for public queries
Name 73351 0
John Tawfik
Address 73351 0
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country 73351 0
Australia
Phone 73351 0
+61 2 9382 7350
Fax 73351 0
Email 73351 0
john@tawfik.com.au
Contact person for scientific queries
Name 73352 0
John Tawfik
Address 73352 0
Sydney Hospital Hand Unit
Macquarie Street
Sydney NSW 2000
Country 73352 0
Australia
Phone 73352 0
+61 2 9382 7350
Fax 73352 0
Email 73352 0
john@tawfik.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.