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
Scientific
Fracture and Orthopedic Clinic
Wirral Hospital NHS Trust
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | All patients that are listed for fasciectomy for Dupuytren's Contracture. |
| Key exclusion criteria | 1. Fasciectomy with skin grafting 2. Fasciectomy for recurrent diseases at the site of previous surgery |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Fracture and Orthopedic Clinic
Wirral
CH49 5PE
United Kingdom
CH49 5PE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |