Randomised controlled trial comparing dermofasciectomy and full thickness skin grafting vs fasciectomy and Z-plasties for the surgical treatment of Dupuytren's contracture of the hand.
| ISRCTN | ISRCTN12186234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12186234 |
| Secondary identifying numbers | N0123137985 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 17/12/2009
- 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
Mr Aamer Ullah
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To see if skin grafting will reduce the incidence of recurrence in the surgical treatment of Dupuytren's contracture when compared to fasciectomy and skin closure. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Dupuytren's disease |
| Intervention | Determine recurrence rates in operated Dupuytren Patients undergoing fasciectomy or full thickness skin grafts |
| Intervention type | Other |
| Primary outcome measure | 1. Recurrence rate and severity 2. Differences in patient satisfaction |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2000 |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Added 17/12/09: 79 patients |
| Key inclusion criteria | Selected from outpatients clinics in Orthopaedic unit |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Not defined
University Hospitals of Leicester NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/03/2009 | Yes | No |
