| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN05011819 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0436146690 |
| Public title | A comparative study of the effects of absorbable and non-absorbable sutures on wound healing - a prospective randomised clinical study |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Injury, Occupational Diseases, Poisoning: Wound healing |
| Study hypothesis | 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. To evaluate the outcome of wound healing in terms of patient satisfaction and comfort.
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| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | This prospective randomized 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). |
| Participants - exclusion criteria | Patients having re-do surgery, patients undergoing combined procedures, patients under the care of the orthopaedic hand surgeons, patient with diabetes, patients known to be steroids or immuno-suppressants |
| Patient information material |
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| Anticipated start date | 01/10/2003 |
| Anticipated end date | 01/10/2004 |
| Status of trial | Completed |
| Target number of participants | 50 |
| Interventions | Randomised controlled trial; Before-after trial |
| Primary outcome measure(s) | 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 measure(s) | See primary outcome measures |
| Sources of funding | Leeds Teaching Hospitals NHS Trust
NHS Research and Development Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Miss S Jivan |
| Contact details | Department of Plastic Surgery
Chancellor Wing
Beckett Street
Leeds
United Kingdom
LS9 7TF |
| Contact telephone | +44 |
| Contact fax | +44 |
| Contact email | Drsjivan@hotmail.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN05011819 |
| Date last extracted from ISRCTN register | 17/04/2008 |
