ISRCTN84928077.

Trial name or title	Randomised controlled trial of platelet rich plasma biotherapies in the management of adult patients with recalcitrant and slow healing wounds following major trauma
Methods	Randomised multicentre controlled study
Participants	Country: UK Number randomised (patients): 100 Wound aetiology: recalcitrant and slow healing wounds following major trauma Age: 18 years and older Sex: Male and female Inclusion criteria: Adults (male and female patients) over 18 years of age. Patients with slow healing wounds and patients with wounds that have not healed within 28 days of the initial injury Exclusion criteria: Patients do not consent to participation or refuse to donate blood for the PRP gel treatment
Interventions	Experimental: 1. Autologel autologous PRP gel plus bovine thrombin until > 90% wound closure is achieved 2. Angel autologous PRP gel plus autologous thrombin until > 90% wound closure is achieved Total anticipated duration of the PRP treatments will be 10 weeks. However the Standard Advanced Wound Care may very well exceed this Comparator: Standard Advanced Wound Care Follow‐up for all treatment will be the same and is as per the standard care pathway for complex wounds involving a multicentre approach
Outcomes	Primary outcome: Time to 90% wound closure as measured by 3D photography. The wounds will be monitored on a weekly basis Secondary outcomes: 1. Quality of life using the SF‐36 health survey (this is the key secondary outcome) 2. Number of treatment 'deferrals' (i.e. temporary rejections) of donors due to low haemoglobin and other factors 3. Markers of platelet concentration, leucocyte levels within the PRP Biotherapies 4. Cognitive ability (reasoning, attention and memory) 5. Levels of physical activity 6. Cost‐effectiveness 7. Donor attitudes, beliefs and values The wounds will be monitored on a weekly basis using 3D photographic measurement. Secondary outcomes regarding wound infection and antibiotic usage will be monitored on a monthly basis
Starting date	31/10/2013
Contact information	Steven Jeffery. The Queen Elizabeth Hospital Mindelsohn Way Edgbaston, B15 2TH, Birmingham, United Kingdom
Notes	Founding: National Institute for Health Research (NIHR) (UK) ‐ Efficacy and Mechanism Evaluation (EME) Programme, Ref 13/55/99