A comparative study of the effects of absorbable and non-absorbable sutures on wound healing - a prospective randomised clinical study
ISRCTN | ISRCTN05011819 |
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DOI | https://doi.org/10.1186/ISRCTN05011819 |
Secondary identifying numbers | N0436146690 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 11/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Miss S Jivan
Scientific
Scientific
Department of Plastic Surgery
Chancellor Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
Drsjivan@hotmail.com |
Study information
Study design | Randomised controlled before-after trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study hypothesis | 1. To compare and evaluate the outcome of elective surgical wound repair in the hand using absorbable and non-absorbable suture materials, in terms of wound infection, scarring, erythema and dehiscence. 2. To evaluate the outcome of wound healing in terms of patient satisfaction and comfort. |
Ethics approval(s) | Not provided at time of registration |
Condition | Injury, Occupational Diseases, Poisoning: Wound healing |
Intervention | Absorbable vs non-absorbable sutures |
Intervention type | Other |
Primary outcome measure | The wounds will be assessed for quality of the scar ie erythema, scarring-hypertrophy and spread, and stitch marks. The upper and lower halves of each wound will be assessed separately. The assessor will not be told which half of the wound was closed using the prolene suture. The patients will also be asked to fill in short questionnaire relating to discomfort to stitch removal and any difference noticed by the patient within each half of the wound in the three/six month post of period. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/10/2003 |
Overall study end date | 01/10/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 50 |
Participant inclusion criteria | This prospective randomised clinical study will be carried out on 50 patients undergoing standard elective carpal tunnel release under local anaesthetic, in the hand surgery day unit at Leeds St. James' Hospital (under the care of the plastic surgical unit). |
Participant exclusion criteria | 1. Patients having re-do surgery 2. Patients undergoing combined procedures 3. Patients under the care of the orthopaedic hand surgeons 4. Patient with diabetes 5. Patients known to be on steroids or immuno-suppressants |
Recruitment start date | 01/10/2003 |
Recruitment end date | 01/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Plastic Surgery
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK), NHS Research and Development Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 | 01/02/2005 | Yes | No |