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
- Conditions
- Pain in split skin graft donor sitesSurgeryComplications of procedures, not elsewhere classified
- Registration Number
- ISRCTN61225564
- Lead Sponsor
- Guy?s and St Thomas? NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method