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
Protocol serial number	GSTT R&D registration number RJ1080009
Sponsor	Guys and St Thomas NHS Foundation Trust (UK)
Funder	Guy's and St Thomas' Hospital (UK) - Plastic Surgery Academic Fund

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Ciaran Healy
Scientific

Consultant Plastic Surgeon
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Primary study design	Interventional
Study design	Randomised active control parallel assignment
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Daily pain and disability scores from day 1 to 14 post-operatively using a Visual Analogue Scale
Key secondary outcome measure(s)	1. Length of hospital stay 2. Duration of requirement for dressings
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Consultant Plastic Surgeon

London
SE1 7EH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes