Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000100695
Ethics application status
Approved
Date submitted
11/01/2023
Date registered
27/01/2023
Date last updated
27/01/2023
Date data sharing statement initially provided
27/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of patient experience with and preference for absorbable and unabsorbable suture for skin closure following carpal tunnel release surgery.
Scientific title
Open Carpal Tunnel Release Surgery with Absorbable vs. Non-Absorbable suture skin closure.
A comparison of pain, function, scar and patient satisfaction.
Secondary ID [1] 308816 0
nil
Universal Trial Number (UTN)
Trial acronym
OCTSS (Open Carpal Tunnel Surgery Suture
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Syndrome 328669 0
Condition category
Condition code
Neurological 325674 325674 0 0
Other neurological disorders
Surgery 325727 325727 0 0
Surgical techniques
Musculoskeletal 325728 325728 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
skin closure following bilateral carpal tunnel release surgery using either absorbable (Vicryl Rapide) or non-absorbable (Proline) suture material.
Surgery to be performed by a Registered Orthopedic Surgeon with 40 years' experience.
Duration 30 minutes including consent, procedure, post-op instructions and follow-up arrangements.
Each patient will receive both sutures or "treatments", one type of suture in each hand with the suture in the first hand randomised.
A data base will be kept to check 2 and 6 week assessments are performed, patients with incomplete data will be excluded.
Intervention code [1] 325230 0
Treatment: Devices
Comparator / control treatment
TIDier.
Suture for skin closure following carpal tunnel surgery.
To determine patient preference for either suture and if there is a difference in recovery, pain and wound healing between the sutures using accepted assessment tools.
The two materials are proline and vicryl rapide suture material , both are readily available with data available at https://www.jnjmedtech.com
The process is to identify patients requiring bilateral simultaneous or sequential carpal tunnel decompression for carpal tunnel syndrome. The trial is explained.
Consenting patients are then asked to complete a questionnaire which includes their handedness, do they have diabetes, use immunosuppressive medication, have an inflammatory arthropathy, use nicotine and have they had a steroid injection or nerve conduction studies. Their BMI and ASA are recorded. They complete a Boston Carpal Tunnel Questionnaire (BCTQ). They are blinded to the suture used.
At 2 and 6 weeks following the operation they are reassessed. At 2 weeks the BCTQ is repeated, a 1-10 Likert scale of pain is assessed before the wound is inspected to perform an ASEPSIS score. At 6 weeks the BCTQ and Likert pain score are repeated, an POSAS observer and patient scar assessment is completed. Patients are then asked if they were to have surgery again would they prefer to suture used on the Right or Left.
The intervention is provided by a registered specialist orthopaedic surgeon. The follow-up assessments are completed by a registered medical practitioner who has had instruction on the grading tools but is blinded to the suture used on each side. Their initial assessments are supervised by the Principle Investigator.
Assessment is face to face. Patients following this type of surgery are normally followed at two and six weeks.
Intervention occurs is the public hospital out-patients department which has a designated operating room.
The intervention of carpal tunnel decompression is delivered once to each hand.
The intervention is the same in each patient with the exception of which suture is used on each side.
No modifications to the procedure have been performed.
The intervention adherence is monitored by the Principal Investigator.
Recruitment will follow approval and adherence monitoring will be ongoing.

.
Control group
Active

Outcomes
Primary outcome [1] 333520 0
Preferred suture material asked whether they preferred the suture used on the left or right hand.
Timepoint [1] 333520 0
6 weeks post-surgery
Secondary outcome [1] 417409 0
A difference in the BCTQ (Boston Carpal Tunnel Questionnaire) which has a SSS (Symptom severity scale) and FSS (Functional status score) between the two hands.
Prior to surgery, 2 weeks post-op and 6 weeks post-surgery.
Timepoint [1] 417409 0
prior to surgery and at 2 and 6 weeks post-surgery.
Secondary outcome [2] 417410 0
1-10 point Likert pain scores between the two hands.
Timepoint [2] 417410 0
2 and 6 weeks post-surgery.
Secondary outcome [3] 417411 0
A difference in the ASEPSIS wound score between the two hands.
A (Additional treatment for example addition of antibiotics)
S (Serous discharge)
E (Erythema)
P (Purulet exudates)
S (Separation of deep tissues)
I (Isolation of bacteria)
S (Stay in hospital prolonged over 14 days)
(ASEPSIS)

Timepoint [3] 417411 0
2 weeks post-surgery
Secondary outcome [4] 417412 0
A difference between the POSAS scar score between the two sutures
Patient and Observer Scar Assessment Tool
(POSAS)
Timepoint [4] 417412 0
6 weeks post-surgery.
Secondary outcome [5] 417642 0
Any complications to be assessed by clinical examination.
Timepoint [5] 417642 0
At any point post operatively to six weeks

Eligibility
Key inclusion criteria
Patients undergoing bilateral carpal tunnel surgery for an established diagnosis of carpal tunnel syndrome.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unilateral carpal tunnel and unilateral only surgery

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The person deciding if the patient is suitable for inclusion is blinded to which suture will be used on the first hand. The allocation is found by matching the next study number to a randomised allocation of first side treatment to that number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
nil
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Specialist statistical analysis to determine whether there was a preference for one or the other suture and whether sufficient numbers have been collected for that result to be valid.
This is to be achieved by periodic statistical assessment but the initial statistical recommendation was to start with greater than 50 patients.
Secondly subgroup analysis to determine whether difference in scar score is greater between patients or between side to side of each patient.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/02/2023
Actual
Date of last participant enrolment
Anticipated
7/11/2023
Actual
Date of last data collection
Anticipated
18/01/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25205 0
New Zealand
State/province [1] 25205 0
Taranaki

Funding & Sponsors
Funding source category [1] 312951 0
Charities/Societies/Foundations
Name [1] 312951 0
Taranaki Medical Foundation
Country [1] 312951 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Taranaki Medical Foundation
Address
Taranaki Base Hospital
Private Bag 2016
New Plymouth
New Zealand 4310
Country
New Zealand
Secondary sponsor category [1] 314641 0
Hospital
Name [1] 314641 0
Taranaki District Health Board
Address [1] 314641 0
Taranaki District Health Board
David St
New Plymouth
New Zealand 4310
Country [1] 314641 0
New Zealand
Other collaborator category [1] 282522 0
Individual
Name [1] 282522 0
Jessica Leary
Address [1] 282522 0
Taranaki Base Hospital
David St
Westown
New Plymouth
New Zealand 4310
Country [1] 282522 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312222 0
Northern B Health and Disability Commission Ethics Committee
Ethics committee address [1] 312222 0
Ministry of Health
133 Molesworth St
Wellington 6011
Po Box 5013
Ethics committee country [1] 312222 0
New Zealand
Date submitted for ethics approval [1] 312222 0
03/05/2021
Approval date [1] 312222 0
11/04/2022
Ethics approval number [1] 312222 0
21/NTB/107
Ethics committee name [2] 312223 0
Taranaki DHB
Ethics committee address [2] 312223 0
David St
Westown
New Plymouth
New Zealand 4310
Ethics committee country [2] 312223 0
New Zealand
Date submitted for ethics approval [2] 312223 0
03/05/2021
Approval date [2] 312223 0
21/12/2021
Ethics approval number [2] 312223 0
no ID approval number

Summary
Brief summary
Aim:To determine whether there is a clinical or patient preference in skin closure after carpal tunnel surgery using an Absorbable (Vicryl Rapide) or Non-absorbable suture material.
Introduction: There are reported benefits of both sutures. The absorbable suture will not need removal with the potential to reduce hospital visits after surgery but the reaction to the suture is said to vary between people. The non-absorbable suture is said to be more inert with less patient reaction but requires removal.
Methods: Patients will be given an approved information sheet and will sign a consent. Consenting Patients undergoing staged or simultaneous bilateral carpal tunnel surgery will have a preoperative assessment with questionnaire assessing ASA grade, BMI screen for other medical problems including inflammatory arthropathy, diabetes, immunosuppressive medication, smoking status, whether nerve conduction studies or local steroid injection has been performed. They will complete a Boston Carpal Tunnel Questionnaire (BCTQ)for each hand.
They will choose which hand they wish to be done first, will be assigned a study number which will randomly allocate a suture to each hand.
The surgery is the same on both sides in all respects apart from the closing suture used.
The patient is blinded to the suture used on each side.
For patient convenience surgery is usually staged with a minimum interval of two weeks but may be extended if other factors dictate for example pregnancy. The interval between surgeries however must fall within the anticipated time period of the study otherwise the patient will be excluded from the study.
Patients will be reviewed at 2 and finally at 6 weeks post-operatively.
At 2 weeks the BCTQ is repeated an ASEPSIS and 10-point Likert Pain Scale is recorded before the wound dressing is disturbed.
At 6 weeks the BCTQ and Likert Scale are repeated, in addition a 7-point POSAS Observer and Patient Scale are performed. The patient is asked which suture they preferred, that used on the Left or Right or did they have no preference.
Any complications are recorded.
Responses will be entered into a data base where patient identification will be by Study Number only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123902 0
Mr Tim Lynskey
Address 123902 0
Taranaki Base Hospital
122B St Aubyn Street
Central
New Plymouth
New Zealand 4310
Country 123902 0
New Zealand
Phone 123902 0
+64274447121
Fax 123902 0
Email 123902 0
t.lynskey@xtra.co.nz
Contact person for public queries
Name 123903 0
Mr Tim Lynskey
Address 123903 0
Taranaki Base Hospital
122B St Aubyn Street
Central
New Plymouth
New Zealand 4310
Country 123903 0
New Zealand
Phone 123903 0
+6467536139
Fax 123903 0
Email 123903 0
t.lynskey@xtra.co.nz
Contact person for scientific queries
Name 123904 0
Mr Tim Lynskey
Address 123904 0
Taranaki Base Hospital
122B St Aubyn Street
Central
New Plymouth
New Zealand 4310
Country 123904 0
New Zealand
Phone 123904 0
+6467536139
Fax 123904 0
Email 123904 0
t.lynskey@xtra.co.nz

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 individual participant data underlying published results once the study is completed.
When will data be available (start and end dates)?
Start immediately following publication, no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims of the approved proposal
How or where can data be obtained?
Access subject to approvals by Principle Investigator at t.lynskey@xtra.co.nz


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.