Condition category
Musculoskeletal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
25/08/2009
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

Ms Kim Howard

ORCID ID

Contact details

Fracture and Orthopedic Clinic
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0280141212

Study information

Scientific title

Acronym

Study hypothesis

Would surgical treatment of Dupuytren's Contracture involves less discomfort for patients if absorbable (dissolving) sutures were used instead of non-absorbable sutures? Would absorbable sutures significantly reduce the amount of time nursing staff need to allocate to the care of patients having surgery for Dupuytrens Contracture?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Musculoskeletal Diseases: Dupuytren's disease

Intervention

Randomised controlled trial:
1. absorbable-vicryl rapide 5/0 sutures
2. non-absorbable-prolene 5/0 sutures

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patients discomfort/pain will be measured using visual analogue and non-parametric Mann Whitney test. The difference in the mean time the nurses spend with the patients in the two groups will be investigated using an independent t-test. Healing complications will probably take form of grouped data and comparisons of the two groups will be dome by chi-squared test.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2004

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients that are listed for fasciectomy for Dupuytren's Contracture.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Minimum of 30 in each group.

Participant exclusion criteria

1. Fasciectomy with skin grafting
2. Fasciectomy for recurrent diseases at the site of previous surgery

Recruitment start date

01/05/2004

Recruitment end date

31/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Fracture and Orthopedic Clinic
Wirral
CH49 5PE
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

Wirral Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19687084

Publication citations

  1. Results

    Howard K, Simison AJ, Morris A, Bhalaik V, A prospective randomised trial of absorbable versus non-absorbable sutures for wound closure after fasciectomy for Dupuytren's contracture., J Hand Surg Eur Vol, 2009, 34, 5, 618-620, doi: 10.1177/1753193409105728.

Additional files

Editorial Notes