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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61225564
Enrollment
50
Registered
2011-11-11
Start date
2008-01-11
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain in split skin graft donor sites Surgery Complications of procedures, not elsewhere classified

Interventions

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

Sponsors

Guy?s and St Thomas? NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Daily pain and disability scores from day 1 to 14 post-operatively using a Visual Analogue Scale

Secondary

MeasureTime frame
1. Length of hospital stay 2. Duration of requirement for dressings

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026