Tri-Solfen Version 3.0

• Research type

  Research Study

• Full title

  An open, randomised, parallel group controlled, single centre safety study to assess the safety and efficacy of Tri-Solfen in providing anaesthesia prior to surgical debridement of leg ulcers and post-operative pain relief

• IRAS ID

  236852

• Contact name

  David Fairlamb

• Contact email

  davidfairlamb@protherax.com

• Sponsor organisation

  Medical Ethics UK Ltd

• Eudract number

  2018-000613-21

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  This is a study to investigate the safety, duration and quality of pain relief following application of topical Tri-Solfen versus standard topical pain relief before surgical debridement of leg ulcer wounds.
  There are 3 phases to this study: Phase 1) A Pilot of 10 participants, designed to assess safety clinically acceptable levels of pain relief.
  Phase 2) 40 participants will be randomised, (20 in each group) to receive a single application of either Tri-Solfen or standard care and,
  Phase 3) 40 participants, 20 in each group) to receive two applications of either Tri-Solfen or standard care.
  In all phases participants will be asked to attend the Wound Healing Research Facility at the University Hospital of Wales on 5 occasions.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  18/EE/0182

• Date of REC Opinion

  11 Jul 2018

• REC opinion

  Further Information Favourable Opinion