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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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
-
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.