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
Protocol serial number	N0084144561
Sponsor	Department of Health
Funder	Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Peter Molitor
Scientific

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

Primary study design	Interventional
Study design	Double blind prospective randomised controlled study
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Northern Lincolnshire & Goole Hospitals NHS Trust

Scunthorpe
DN15 7BH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2005		Yes	No