Presentation on theme: "STOPCUTS The STOPCUTS Study A Randomised Controlled Trial of Protective socks against Usual Care to Reduce Skin Tears in High Risk People Living in Care."— Presentation transcript:
STOPCUTS The STOPCUTS Study A Randomised Controlled Trial of Protective socks against Usual Care to Reduce Skin Tears in High Risk People Living in Care Homes: A Pilot Study Chief Investigator: Dr Roy Powell, BSc (Hons) PhD Research Nurses: Linda Park RN RM BSc Kathy Polverino Dip HE RN
Skin Tear Definition “A skin tear injury is a traumatic injury… occurring principally on the extremities of older adults… as a result of shearing or friction forces… which separate the epidermis from the dermis (partial thickness wound)… or which separate both the epidermis and the dermis from underlying structures (full-thickness wound)”. Payne & Martin (1993) Ostomy Wound Manage 39, 16-26.
CATEGORY I SKIN TEAR WITHOUT TISSUE LOSS
CATEGORY II SKIN TEAR WITH PARTIAL SKIN LOSS
CATEGORY III SKIN TEAR WITH FULL SKIN LOSS
Background Skin tears are common – The commonest health problem that community nurses see. – N. Devon prevalence in 16 care homes & 458 residents. 25% had wounds. 19% were traumatic injuries (Kingsley et al, 2010). With age, skin becomes thinner and more fragile – 7.4 million people in UK over 70yrs in 2011. Medications e.g. long-term steroids compromise skin integrity and strength. Our activities for daily living also become more hazardous. Injuries from equipment such as wheelchairs, hoists, cot sides etc.
The Socks The protective socks are: Manufactured by Dermatuff Ltd., are CE-marked and registered with the MHRA. Woven using impact-resistant yarns purpose–spun from Kevlar together with elasticated nylon Have a mesh of loops on the inside and slightly ribbed surface on the outside Give impact resistance Do not offer any compression
RfPB grant and amendments Original application – for RfPB Competition 16, deadline 20 th Sept 2011. Provisionally approved – 26 th March 2012. Four main queries that we responded to – 16 th April 2012 – suitable comparator, possible contamination, use of smart phones/cameras, and measuring adherence. An amended RfPB application for a grant of £249,232.00 was sent 12 th July 2012 and approved. Then we started writing the protocol……..
STOPCUTS team The STOPCUTS team Original RfPB applicants: Roy Powell – CI. Research Design Advisor/biostatistician Rohan Chauhan – Research Advisor/ Qualitative researcher Carolyn Charman – Consultant Dermatologist Andrew Kingsley – Clinical manager, Infection Control and Tissue Viability. Philip Evans – then Director of PCRN-SW and GP Janine Prytherch – Head of Tissue Viability Service (retired) Colin Pritchard – Research Design Advisor/ Health economist (retired) Barbara Rochester – Lay member
STOPCUTS team – other Trial Management Group members since June 2012 The STOPCUTS team – other Trial Management Group members since June 2012 Nicola Walker – Research nurse Kathleen Polverino – Research nurse Linda Park – Research nurse Chris Hayward – Clinical Trials Manager PenCTU Caroline Snelgrove – Assistant Clinical Trials Manager PenCTU Anoushka Tepielow - Assistant R&D Directorate Manager, RD&E Alison Kerridge – Assistant R&D Directorate Manager Justine Thelwell - The Lodge Care Home Exeter George Coxon – Care home owner/manager Rachel Byford – then Data Officer, CRN-SWP Christopher Foy – Health economist Sue Crampton – Assistant Research Manager, PenCRN Kate Moore – Finance Officer RD&EFT
Local Care homes approved by CQC (not EMI homes) http://www.carehome.co.uk/carehome.cfm/searchazref/20002015LODA
Study Summary Open, randomised, controlled study. 24 month study duration; recruitment (homes & participants), data collection, analysis/write-up. Recruit 90 participants Randomised 1:1 to a) wear socks b) not wear socks (control group) 16 week (112 days) follow-up period for each participant.
Aims and Objectives Pilot study: aim to provide the necessary information for the planning of a future trial. The study will test the feasibility of: running an eventual definitive trial. gathering data on skin tears occurring in care homes and the community. providing estimates of: - Recruitment (homes and residents/patients) - Completion of quality of life questionnaires
Aims and Objectives cont. The study will assess the acceptability of: using the socks participating in the study The primary outcome measure of the study will be the number of skin tear free days
Plan: Gantt chart
Recruitment since 1 st July 2013
Sources of participants Care homes (Exeter): 16 Care homes (Exmouth/Sidmouth): 36 Primary Care: 26 Exeter 10,000 volunteers: 12 Care homes: 52 Community: 38
What’s different about this trial? A novel intervention – Kevlar socks One of the few trials of prevention of skin tears. Only the 2 nd trial in the region to involve care homes. Recruiting from the community also. Nursing responsibilities and input/decision making. A close collaboration of many different areas of healthcare and the care home sector: general practice, dermatology, tissue viability Electronic recruitment, randomisation and data capture via smart phones and PenCTU team
Thanks to all involved! Not just: – the original RfPB grant applicants – The Trial Management Group But also: – The PenCTU team. – The RD&E R&D Dept & CRN-SWP admin. staff – The Independent Trial Steering Committee – The Care homes, their staff and residents – Primary care, GP practices, staff and patients – Clinical Research Facility & Exeter 10,000 volunteers – My colleagues in the Research Design Service - SW – Dermatuff Ltd for supplying the socks!