Protocol generation for future ultrasound stimulated wound healing
Research type
Research Study
Full title
Pragmatic Feasibility study of protocol for future translational Proof of Product Clinical trials of ultrasound stimulated wound healing
IRAS ID
204082
Contact name
Anna-Victoria Giblin
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This research aims to develop a pragmatic protocol, within the current plastic surgery follow-up clinic setting, at the Northern General Hospital, for photographic area assessment of and treatment system acceptability in skin graft donor site wounds (uniform size, depth, aetiology, position, common wounds, with routine 1 and 2 week review).
The department carries out a minimum of 20 skin grafts each month and these patients are discussed each morning in trauma clinic before being operated on. They would be approached at this time and checks for wish to participate made at the 1 and 2 week reviews during which a wound photograph would be taken through their transparent donor site dressing and a validated questionnaire be completed (week 1) re acceptability, pain. The study will last 6 months.
This is to prepare a protocol for future planned translational studies involving ultrasonic stimulation of chronic wound healing which has been successful in animal models. An in vitro study of optimal ultrasound stimulation of human fibroblasts will be running concurrently with this feasibility study (Dr Bass, Sheffield University). The ultimate aim of this work is make feasible, trials into a cheap, safe, efficient system by which to improve healing in intransigent and difficult wounds such as those frequently seen in trauma and burn patients, diabetics and vasculopaths which result in significant burden on the Health Service and low quality of life for the patients and their carers.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0229
Date of REC Opinion
27 May 2016
REC opinion
Further Information Favourable Opinion