title: Pilot randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people "STOPCUTS": study protocol.
abstract: BACKGROUND
  Skin tears are traumatic injuries occurring mostly on the extremities due to shearing and friction forces that separate the epidermis and the dermis from underlying tissues. They are common and occur mostly in older adults and those taking medications that compromise skin integrity. Pretibial skin tears can develop into leg ulcers, which require lengthy, expensive treatment to heal. Traumatic injuries are the second most common type of wounds after pressure ulcers in care homes and are the commonest reason for older adults to require the attention of a community nurse. Common causes of skin tear injuries are bumping into furniture and other obstacles, using mobility aids, transfer to/from wheelchairs, getting in and out of bed and falls. No effective preventative measures currently exist but knee-length, protective socks are now available that contain impact-resistant Kevlar fibres (of the type used in stab-proof vests) and cushioning layers underneath.
  
  
  METHODS
  In this pilot parallel group, randomised controlled trial, 90 people at risk of skin-tear injury will be randomised with equal allocation to receive the intervention or usual care. They will be recruited from care homes and from the community via general practices and a research volunteer database. Pilot outcomes include recruitment, eligibility, attrition, ascertainment of injuries and completion of outcome measures. Acceptability of the intervention and of study participation will be explored using semi-structured interviews. The proposed primary outcome for the future definitive trial is skin tear-free days. Secondary outcomes are skin tear severity, health status, specific skin-tears quality of life, capability and fear of falling, measured at baseline and the end of the study and in the event of a skin tear.
  
  
  CONCLUSIONS
  The results of this study will be used to inform the development and design of a future randomised controlled trial to assess the effectiveness and cost-effectiveness of a unique and innovative approach to skin tear prevention. Approval was granted by the NRES - Cornwall and Plymouth Research Ethics Committee (13/SW/013). Dissemination will include publication of quantitative and qualitative findings, and experience of public involvement in peer-reviewed journals.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN96565376.
authors.affiliation: Research and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, EX2 5DW Exeter, Devon UK.
authors.forename: Roy J
authors.initials: RJ
authors.lastname: Powell
authors.affiliation: Peninsula Clinical Trials Unit at Plymouth University (PenCTU), ITTC Building, Plymouth Science Park, PL6 8BX Plymouth, Devon UK.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Hayward
authors.affiliation: Peninsula Clinical Trials Unit at Plymouth University (PenCTU), ITTC Building, Plymouth Science Park, PL6 8BX Plymouth, Devon UK.
authors.forename: Caroline L
authors.initials: CL
authors.lastname: Snelgrove
authors.affiliation: Research and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, EX2 5DW Exeter, Devon UK.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Polverino
authors.affiliation: Research and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, EX2 5DW Exeter, Devon UK.
authors.forename: Linda
authors.initials: L
authors.lastname: Park
authors.affiliation: Research and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, EX2 5DW Exeter, Devon UK.
authors.forename: Rohan
authors.initials: R
authors.lastname: Chauhan
authors.affiliation: University of Exeter Medical School, St Luke's Campus, Magdalen Road, EX1 2 LU Exeter, Devon UK.
authors.forename: Philip H
authors.initials: PH
authors.lastname: Evans
authors.affiliation: NIHR Clinical Research Network, South West Peninsula, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, EX2 5DW Exeter, Devon UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Byford
authors.affiliation: Research and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, EX2 5DW Exeter, Devon UK.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Charman
authors.affiliation: Research and Development Office, Leadom House, Gloucester Royal Hospital, GL1 3NN Gloucester, Gloucestershire UK.
authors.forename: Christopher J W
authors.initials: CJ
authors.lastname: Foy
authors.affiliation: Northern, Eastern and Western Devon Clinical Commissioning Group, County Hall, Topsham Road, EX2 4QD Exeter, Devon UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Kingsley
keywords: Dermatuff; Pre-tibial lacerations; Prevention; Protective socks; Skin tears