A double blind prospective randomised controlled study comparing absorbable versus non-absorbable suture techniques in Carpal Tunnel Release.

ISRCTN ISRCTN41229063
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

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe General Hospital
Cliff Gardens
Scunthorpe
DN15 7BH
United Kingdom

Study information

Study designDouble blind prospective randomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesComparison 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) studiedNervous System Diseases: Carpal tunnel syndrome (CTS)
InterventionAfter 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/04/2003
Completion date30/04/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants40
Key inclusion criteria40 patients, aged between 18 to 75 years are invited to participate in the study.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2003
Date of final enrolment30/04/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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