A double blind prospective randomised controlled study comparing absorbable versus non-absorbable suture techniques in Carpal Tunnel Release.
ISRCTN | ISRCTN41229063 |
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DOI | https://doi.org/10.1186/ISRCTN41229063 |
Secondary identifying numbers | N0084144561 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 02/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Peter Molitor
Scientific
Scientific
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom
Study information
Study design | Double blind prospective randomised controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Comparison of suturing techniques: the absorbable suturing technique of parpal tunnel release and the non-absorbable suturing technique, in terms of patient pain perception, scar tenderness and wound healing. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Nervous System Diseases: Carpal tunnel syndrome (CTS) |
Intervention | After patients have agreed to participate, they will be randomised into one or other of the treatment arms: 1. Technique A = Using a continuous subcuticular absorbable 3.0 polyglactin 910 (vicryl) suture 2. Technique B = Using interrupted non-absorbable 3.0 monofilament polypropylene (prolene) suture |
Intervention type | Other |
Primary outcome measure | 1. Residual postoperative pain using Visual Analogue Scale 2. Scar tenderness 3. Preoperative and postoperative symptoms using CTS Symptom Severity Score 4. Preoperative and postoperative functional status using CTS Functional Status Scale 5. Extent of wound healing |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/04/2003 |
Completion date | 30/04/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 40 |
Key inclusion criteria | 40 patients, aged between 18 to 75 years are invited to participate in the study. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/04/2003 |
Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
DN15 7BH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/02/2005 | Yes | No |