Study to evaluate pain in split skin graft donor sites dressed with fibrin sealant (Tisseel®, Baxter) and adhesive dressings versus adhesive dressings directly applied to the donor site
| ISRCTN | ISRCTN61225564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61225564 |
| Secondary identifying numbers | GSTT R&D registration number RJ1080009 |
- Submission date
- 02/03/2011
- Registration date
- 11/11/2011
- Last edited
- 06/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Ciaran Healy
Scientific
Scientific
Consultant Plastic Surgeon
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised active control parallel assignment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective, controlled, randomised study to evaluate pain in split skin graft donor sites dressed with fibrin sealant (Tisseel®, Baxter) and adhesive dressings versus adhesive dressings directly applied to the donor site |
| Study objectives | Fibrin sealant significantly reduces pain in split skin graft donor sites |
| Ethics approval(s) | Ethics approval obtained from Guys and St Thomas' Ethics Committee on 11th January 2008, ref: 06Q0701/92 |
| Health condition(s) or problem(s) studied | Pain in split skin graft donor sites |
| Intervention | A prospective, randomised controlled trial was performed. The self-adhesive fabric dressing Mefix® (Mölnlycke Health Care Ltd) was used as a control and compared to fibrin glue spray (Tisseel®, Baxter Healthcare Ltd) plus Mefix®. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Daily pain and disability scores from day 1 to 14 post-operatively using a Visual Analogue Scale |
| Secondary outcome measures | 1. Length of hospital stay 2. Duration of requirement for dressings |
| Overall study start date | 11/01/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. 18 years old and over 2. Conscious during post operative period 3. Small to moderate area of split skin graft (SSG) procedure necessary 4. Lateral thigh SSG donor site preferable |
| Key exclusion criteria | 1. Hypersensitivity to beef or beef products ((Tisseel® is produced from bovine aprotonin) 2. Those requiring thicker grafts, greater than 8/1000 inch 3. Thigh donor sites unavailable. Back and buttocks can be used as donor sites in certain cases, they may have a different pain profile 4. Known immunodeficiency will have an effect on healing 5. Mental incapacity to consent or undertake questionnaire 6. Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days to avoid confounding factors 7. Alternative source of severe distracting pain which may down score donor site pain |
| Date of first enrolment | 11/01/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Plastic Surgeon
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guys and St Thomas NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Consultant Plastic Surgeon
c/o Mr Ciaran Healy (Principal Investigator)
Department of Plastic Surgery
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Hospital/treatment centre
Guy's and St Thomas' Hospital (UK) - Plastic Surgery Academic Fund
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 | 01/07/2013 | Yes | No |
