Should the wound be closed with absorbable or non-absorbable sutures after surgery for Dupuytrens Contracture

ISRCTN ISRCTN85526661
DOI https://doi.org/10.1186/ISRCTN85526661
Protocol serial number N0280141212
Sponsor Department of Health
Funders Wirral Hospitals NHS Trust (UK), NHS R&D Support Funding
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
25/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Kim Howard
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesWould 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMusculoskeletal Diseases: Dupuytren's disease
InterventionRandomised controlled trial:
1. absorbable-vicryl rapide 5/0 sutures
2. non-absorbable-prolene 5/0 sutures
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration60
Key inclusion criteriaAll patients that are listed for fasciectomy for Dupuytren's Contracture.
Key exclusion criteria1. Fasciectomy with skin grafting
2. Fasciectomy for recurrent diseases at the site of previous surgery
Date of first enrolment01/05/2004
Date of final enrolment31/05/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Fracture and Orthopedic Clinic
Wirral
CH49 5PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2009 Yes No