Evidence map›Paper›PMID 29075507›Full record

ArticlePilot and feasibility studies2017

Pilot parallel randomised controlled trial of protective socks against usual care to reduce skin tears in high risk people: 'STOPCUTS'.

Roy J Powell, Christopher J Hayward, Caroline L Snelgrove, Kathleen Polverino, Linda Park, Rohan Chauhan, Philip H Evans, Rachel Byford, Carolyn Charman, Christopher J W Foy and 2 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.6field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Roy J PowellResearch and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW United Kingdom.
Christopher J HaywardPeninsula Clinical Trials Unit (PenCTU), ITTC Building, Plymouth Science Park, Plymouth, PL6 8BX United Kingdom.
Caroline L SnelgrovePeninsula Clinical Trials Unit (PenCTU), ITTC Building, Plymouth Science Park, Plymouth, PL6 8BX United Kingdom.
Kathleen PolverinoResearch and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW United Kingdom.
Linda ParkResearch and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW United Kingdom.
Rohan ChauhanResearch and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW United Kingdom.
Philip H EvansUniversity of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU United Kingdom.
Rachel ByfordNIHR Clinical Research Network, South West Peninsula, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW United Kingdom.
Carolyn CharmanResearch and Development Directorate, Noy Scott House, Royal Devon and Exeter NHS Foundation Trust, Barrack Road, Exeter, EX2 5DW United Kingdom.
Christopher J W FoyResearch and Development Office, Leadom House, Gloucester Royal Hospital, Gloucester, GL1 3NN United Kingdom.
Colin PritchardRoyal Cornwall Hospital (Treliske), Treliske, Truro United Kingdom.
Andrew KingsleyNorthern, Eastern and Western Devon Clinical Commissioning Group, County Hall, Topsham Road, Exeter, Devon EX2 4QD United Kingdom.
Royal Devon & Exeter NHS Foundation Trust · GBUniversity of Exeter · GBGloucestershire Royal Hospital · GBPeninsula College of Medicine and Dentistry · GBRoyal Cornwall Hospital · GB

Funding

Department of Health PB-PG-0711-25129
6 · The paper itself

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.

Indexed as

‘Dermatuff’KevlarPre-tibial lacerationsPreventionProtective socksSkin tears

Identifiers

PMID29075507
PMCPMC5644264
OpenAlexW2761115901

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.