A case series of platelet rich plasma for pressure ulcers
Research type
Research Study
Full title
THROMBI-PU: A case series of platelet-rich plasma for pressure ulcers
IRAS ID
252208
Contact name
Ash Mosahebi
Contact email
Sponsor organisation
Biotherapy Services Ltd
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Platelet-rich plasma (PRP) is a rich source of growth factors important for tissue repair and regeneration. PRP is increasingly used to treat a variety of chronic conditions such as scarring, radiotherapy damage and osteoarthritis. It has been shown to produce good clinical outcomes in difficult-to-heal wounds, however, the evidence is limited.
PRP acts via the release of growth factors from alpha granules contained within platelets and in order for this to occur the PRP must be 'activated' by an external source. Evidence for the most efficacious method of activation is very limited with several different methods discussed in the literature. Activat is a commercially available device which activates PRP via mixing with 10% calcium chloride and ethanol and then shaking the mixture in a syringe filled with small resin beads to increase contact surface area between platelets and the chemicals. The resultant PRP gel formed acts as a growth-factor secreting biological dressing and is classified as a medicinal product. Thrombinator is another commercially available device that activates PRP through mixing with 10% calcium chloride only and shaking the mixture in a device filled with larger glass beads. This produces a similar gel dressing. Preliminary laboratory studies of both devices have shown they both release high concentrations of growth factors over a 24hour period. However, evidence of there clinical efficacy is limited.
We wish to compare a PRP activation device against standard care to evaluate the efficacy of this treatment in the healing of chronic and slowly healing pressure ulcers. PRP preparations and preparation device have been previously trial and received their own study ethics. Our study is aimed at determining efficacy and does not introduce a new device or medicinal product. We wish to evaluate the objective clinical efficacy of autologous thrombin in this preparation.REC name
London - Queen Square Research Ethics Committee
REC reference
21/PR/0466
Date of REC Opinion
24 Aug 2021
REC opinion
Further Information Favourable Opinion