Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084144561
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Double blind prospective randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2003
Overall trial end date
30/04/2004
Reason abandoned
Eligibility
Participant inclusion criteria
40 patients, aged between 18 to 75 years are invited to participate in the study.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2003
Recruitment end date
30/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northern Lincolnshire & Goole Hospitals NHS Trust
Scunthorpe
DN15 7BH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15620502
Publication citations
-
Results
Kharwadkar N, Naique S, Molitor PJ, Prospective randomized trial comparing absorbable and non-absorbable sutures in open carpal tunnel release., J Hand Surg Br, 2005, 30, 1, 92-95, doi: 10.1016/j.jhsb.2004.10.009.