Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/09/2012
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

Miss S Jivan

ORCID ID

Contact details

Department of Plastic Surgery
Chancellor Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Drsjivan@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436146690

Study information

Scientific title

Acronym

Study hypothesis

1. To compare and evaluate the outcome of elective surgical wound repair in the hand using absorbable and non-absorbable suture materials, in terms of wound infection, scarring, erythema and dehiscence.
2. To evaluate the outcome of wound healing in terms of patient satisfaction and comfort.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled before-after trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Wound healing

Intervention

Absorbable vs non-absorbable sutures

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The wounds will be assessed for quality of the scar ie erythema, scarring-hypertrophy and spread, and stitch marks. The upper and lower halves of each wound will be assessed separately. The assessor will not be told which half of the wound was closed using the prolene suture. The patients will also be asked to fill in short questionnaire relating to discomfort to stitch removal and any difference noticed by the patient within each half of the wound in the three/six month post of period.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

This prospective randomised clinical study will be carried out on 50 patients undergoing standard elective carpal tunnel release under local anaesthetic, in the hand surgery day unit at Leeds St. James' Hospital (under the care of the plastic surgical unit).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patients having re-do surgery
2. Patients undergoing combined procedures
3. Patients under the care of the orthopaedic hand surgeons
4. Patient with diabetes
5. Patients known to be on steroids or immuno-suppressants

Recruitment start date

01/10/2003

Recruitment end date

01/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Plastic Surgery
Leeds
LS9 7TF
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

Leeds Teaching Hospitals NHS Trust (UK), NHS Research and Development 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

1. 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