Transcript STOPCUTS A RANDOMISED CONTROLLED TRIAL OF PROTECTIVE

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
Peter Thornton: Dermatuff Ltd
SKIN TEAR DEFINITION
Category 3 (STAR Skin Tear Classification System Guidelines)
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.
DERMATUFF socks
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 20th Sept 2011.
• Provisionally approved – 26th March 2012.
• Four main queries that we responded to – 16th
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 12th July 2012 and
approved.
• Then we started writing the protocol……..
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
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 1st 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 2nd 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!