Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000559819
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
12/05/2021
Date last updated
12/05/2021
Date data sharing statement initially provided
12/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Absorbable vs Non-absorbable Sutures in Adults Undergoing Carpal Tunnel Release
Scientific title
Comparing pain, scar satisfaction and infection rates in Adults undergoing Carpal Tunnel Release with Absorbable vs Non-absorbable Sutures
Secondary ID [1] 303638 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Syndrome 321023 0
Condition category
Condition code
Skin 318825 318825 0 0
Other skin conditions
Musculoskeletal 318826 318826 0 0
Other muscular and skeletal disorders
Surgery 319271 319271 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Absorbable sutures (Vicryl Rapide) or Non-absorbable (Nylon) for carpal tunnel skin closure.
Each patient will receive both "treatments", one type of suture in each hand, with the first hand being randomised.

Surgeries will be performed one at a time, rather than both on the same day (current standard practice). The surgeries will be administered by a consultant orthopedic surgeon for every case (not trainees). At the present moment we have two surgeons on board to participate in the trial. Both are highly experienced in carpal tunnel surgery.

Surgery involves local anesthesia, carpal tunnel release, closure of the skin only (carpal tunnel not closed). Skin sutures are generally interrupted. Each surgeon is required to do the same technique (eg interrupted, mattress) for both suture materials. Most of this is already current standard practice and we do not feel the need to monitor the surgeon. The only part that will be monitored is if the same suture technique was used in each had, and this can easily be established on the 2 week follow-up when sutures are visually inspected by a clinical professional.
Intervention code [1] 319926 0
Treatment: Surgery
Comparator / control treatment
Non-absorbable sutures will be regarded as the reference comparator
Control group
Active

Outcomes
Primary outcome [1] 326773 0
Pain from Scar - Visual Analogue Scale (from 1 - 10)
Timepoint [1] 326773 0
2 and 6 weeks
2 weeks is the primary timepoint
Secondary outcome [1] 392630 0
Scar appearance/ satisfaction - POSAS scoring tool
Timepoint [1] 392630 0
6 weeks
Secondary outcome [2] 393963 0
Infection rate/Wound healing - infection as determined clinically and/or by ASEPSIS wound score
Timepoint [2] 393963 0
2 weeks
Secondary outcome [3] 393964 0
Required return to theatre - as per the clinical notes
Timepoint [3] 393964 0
6 weeks

Eligibility
Key inclusion criteria
Patients at Taranaki DHB needing staged bilateral carpal tunnel release
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent
Wound healing issues (eg history of keloid scarring)
Concomitant hand surgery

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)
Randomly allocated using a premade randomisation sheet after the patient has been accepted and has consented. Therefore the person including people in the trial is unaware of which arm the patient will be placed in until after they have been included.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Software assisted simple randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/05/2021
Actual
Date of last participant enrolment
Anticipated
6/12/2021
Actual
Date of last data collection
Anticipated
25/01/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 23522 0
New Zealand
State/province [1] 23522 0
Taranaki

Funding & Sponsors
Funding source category [1] 308058 0
Charities/Societies/Foundations
Name [1] 308058 0
Taranaki Medical Foundation
Country [1] 308058 0
New Zealand
Primary sponsor type
Individual
Name
Dr. Andrew Muller
Address
Department of Orthopaedics
Taranaki Base Hospital
David Street
Westown
New Plymouth
Taranaki
4310
Country
New Zealand
Secondary sponsor category [1] 308787 0
Individual
Name [1] 308787 0
Tim Lynskey
Address [1] 308787 0
Department of Orthopaedics
Taranaki Base Hospital
David Street
Westown
New Plymouth
Taranaki
4310
Country [1] 308787 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308050 0
Health and Disability Ethics Committee
Ethics committee address [1] 308050 0
Ethics committee country [1] 308050 0
New Zealand
Date submitted for ethics approval [1] 308050 0
19/04/2021
Approval date [1] 308050 0
03/05/2021
Ethics approval number [1] 308050 0
21/NTB/107

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

Contacts
Principal investigator
Name 109346 0
Dr Andrew Muller
Address 109346 0
Department of Orthopaedics
Taranaki Base Hospital
David Street
Westown
New Plymouth
Taranaki
4310
Country 109346 0
New Zealand
Phone 109346 0
+64 210639964
Fax 109346 0
Email 109346 0
andrew.lee.muller@gmail.com
Contact person for public queries
Name 109347 0
Dr. Andrew Muller
Address 109347 0
Department of Orthopaedics
Taranaki Base Hospital
David Street
Westown
New Plymouth
Taranaki
4310
Country 109347 0
New Zealand
Phone 109347 0
+64 6 753 6139
Fax 109347 0
Email 109347 0
andrew.muller@tdhb.org.nz
Contact person for scientific queries
Name 109348 0
Andrew Muller
Address 109348 0
Department of Orthopaedics
Taranaki Base Hospital
David Street
Westown
New Plymouth
Taranaki
4310
Country 109348 0
New Zealand
Phone 109348 0
+64 210639964
Fax 109348 0
Email 109348 0
andrew.lee.muller@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Fully anonymised data in Excel Spreadsheet can be accessed on email request
When will data be available (start and end dates)?
From time of publication, no end date
Available to whom?
Researchers
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Via email on a case by case basis
andrew.muller@tdhb.org.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10953Study protocol  andrew.muller@tdhb.org.nz 381572-(Uploaded-12-04-2021-08-56-14)-Study-related document.docx
11347Informed consent form    381572-(Uploaded-12-04-2021-08-56-50)-Study-related document.docx
11348Clinical study report  andrew.muller@tdhb.org.nz
11349Ethical approval  andrew.muller@tdhb.org.nz



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.