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Clinical Trials/ISRCTN61225564
ISRCTN61225564
Completed
Not Applicable

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

Guy?s and St Thomas? NHS Foundation Trust (UK)0 sites50 target enrollmentNovember 11, 2011
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ConditionsPain in split skin graft donor sitesSurgeryComplications of procedures, not elsewhere classified

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain in split skin graft donor sites
Sponsor
Guy?s and St Thomas? NHS Foundation Trust (UK)
Enrollment
50
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 11, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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