Condition category
Nervous System Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
02/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Molitor

ORCID ID

Contact details

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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes