Pilot parallel randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people: \u2018STOPCUTS\u2019

Roy J Powell,Kathleen Polverino,Colin Pritchard,Carolyn Charman,Christopher J W Foy,Rohan Chauhan,Philip H Evans,Christopher J Hayward,Linda Park,Rachel Byford,Caroline L Snelgrove,Andrew Kingsley

doi:10.1186/s40814-017-0182-3

Abstract

BackgroundSkin tears are common in older adults and those taking steroids and warfarin. They are traumatic, often blunt injuries caused by oblique knocks to the extremities. The epidermis may separate from the dermis or both layers from underlying tissues leaving a skin flap or total loss of tissue, which is painful and prone to infection. ‘Dermatuff™’ knee-length socks containing Kevlar fibres (used in stab-proof vests and motorcyclists’ clothing) aim to prevent skin tears. The acceptability of the socks and the feasibility of a randomised controlled trial (RCT) had not been explored.MethodsIn this pilot parallel group RCT, 90 people at risk of skin-tear injury from Devon care homes and primary care were randomised to receive the socks or treatment as usual (TAU). The pilot aimed to estimate parameters to inform the design of a substantive trial and record professionals’ views and participants’ acceptability of the intervention and of study participation.ResultsParticipants were randomised from July 2013 and followed up until February 2015. Community participants were easier to recruit than care homes residents but were 10 years younger on average and more active. To recruit 90 participants, 395 had to be approached overall as 77% were excluded or declined. Seventy-nine participants (88%) completed the trial and 27/44 (61%) wore the socks for 16 weeks. There were 31 skin tear injuries affecting 18 (20%) of the 90 participants. The TAU group received more injuries, more repeated episodes, and larger tears with greater severity. Common daily diary reasons for not wearing the socks included perceived warmth in hot weather or not being available (holiday, in hospital, bed rest). Resource use data were obtainable and indicated that sock wearing gave a reduction in treatment costs whilst well-completed questionnaires showed improvements in secondary outcomes.ConclusionsThis pilot trial has successfully informed the design and conduct of a future definitive cost-effectiveness RCT. It would need to be conducted in primary care with 880 active at-risk, elderly patients (440 per arm). Skin tear incidence and quality of life (from EQ5D5L) over a 4-month period would be the primary and secondary outcomes respectively.Trial registrationISRCTN, ISRCTN96565376.

Highlights

Skin tears are common in older adults and those taking steroids and warfarin
Skin tears are traumatic wounds involving a piece of skin of varying size being peeled away from underlying tissues either completely or leaving a partial or intact skin flap
Until 2011, the most commonly cited definition of a skin tear was that of Payne and Martin: ‘A skin tear 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 or which separate both the epidermis and the dermis from underlying structures’ [1]

Summary

Introduction

Skin tears are common in older adults and those taking steroids and warfarin They are traumatic, often blunt injuries caused by oblique knocks to the extremities. Until 2011, the most commonly cited definition of a skin tear was that of Payne and Martin: ‘A skin tear 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)’ [1]. Traumatic injuries (skin tears) were the second most common wound type (37, 19%) after pressure ulcers (87, 45%)

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