Presentation is loading. Please wait.

Presentation is loading. Please wait.

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.

Similar presentations


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:

1 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

2 Peter Thornton: Dermatuff Ltd

3 SKIN TEAR DEFINITION Category 3 (STAR Skin Tear Classification System Guidelines)

4 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,

5 CATEGORY I SKIN TEAR WITHOUT TISSUE LOSS

6 CATEGORY II SKIN TEAR WITH PARTIAL SKIN LOSS

7 CATEGORY III SKIN TEAR WITH FULL SKIN LOSS

8 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 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.

9 DERMATUFF socks

10 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

11 RfPB grant and amendments Original application – for RfPB Competition 16, deadline 20 th Sept Provisionally approved – 26 th March 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, was sent 12 th July 2012 and approved. Then we started writing the protocol……..

12 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

13 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

14 Local Care homes approved by CQC (not EMI homes)

15 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.

16 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

17 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

18 Plan: Gantt chart

19 Recruitment since 1 st July 2013

20 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

21 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

22 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!


Download ppt "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."

Similar presentations


Ads by Google