A comparative study of the effects of absorbable and non-absorbable sutures on wound healing - a prospective randomised clinical study
| ISRCTN | ISRCTN05011819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05011819 |
| Protocol serial number | N0436146690 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK), NHS Research and Development Support Funding |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled before-after trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Injury, Occupational Diseases, Poisoning: Wound healing |
| Intervention | Absorbable vs non-absorbable sutures |
| Intervention type | Other |
| 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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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). |
| Key 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 |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Plastic Surgery
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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 | 01/02/2005 | Yes | No |
