Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GSTT R&D registration number RJ1080009
Study information
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
Acronym
Study hypothesis
Fibrin sealant significantly reduces pain in split skin graft donor sites
Ethics approval
Ethics approval obtained from Guys and St Thomas' Ethics Committee on 11th January 2008, ref: 06Q0701/92
Study design
Randomised active control parallel assignment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
11/01/2008
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
11/01/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Plastic Surgeon
London
SE1 7EH
United Kingdom
Sponsor information
Funders
Funder type
Hospital/treatment centre
Funder name
Guy's and St Thomas' Hospital (UK) - Plastic Surgery Academic Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23806933
Publication citations
-
Results
Healy C, Greig AV, Murphy AD, Powell C, Pinder RJ, Saour S, Abela C, Knight W, Geh JL, Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain., Plast. Reconstr. Surg., 2013, 132, 1, 139e-46e, doi: 10.1097/PRS.0b013e318299c6f4.