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Pressure-relieving devices for treating heel pressure ulcers

  1. Elizabeth McGinnis1,*,
  2. Nikki Stubbs2

Editorial Group: Cochrane Wounds Group

Published Online: 12 FEB 2014

Assessed as up-to-date: 10 MAY 2013

DOI: 10.1002/14651858.CD005485.pub3


How to Cite

McGinnis E, Stubbs N. Pressure-relieving devices for treating heel pressure ulcers. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD005485. DOI: 10.1002/14651858.CD005485.pub3.

Author Information

  1. 1

    Leeds Teaching Hospitals NHS Trust, Leeds, UK

  2. 2

    Leeds Community Health Care NHS Trust, St Mary's Hospital, Tissue Viability, Leeds, UK

*Elizabeth McGinnis, Leeds Teaching Hospitals NHS Trust, c/o 2nd Floor Stable Block, Old Trust HQ, Leeds General Infirmary, Great George St, Leeds, LS1 3EX, UK. Elizabeth.mcginnis@leedsth.nhs.uk. e.mcginnis@btinternet.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 12 FEB 2014

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Characteristics of included studies [ordered by study ID]
Russell 2000

MethodsRCT, study duration was originally planned to be 12 months but extended to 18 months. Patients were followed up till they healed, were discharged or died


Participants141 patients in total, 113 with heel pressure ulcers (55 on one alternating mattress system, 58 on the other alternating mattress system). All participants were recruited from a health care of the elderly unit in a UK hospital, average age 84 years. Patients suffered from diseases such as cardiovascular, dementia, malignancy and orthopaedic problems


Interventions1. Huntleigh Nimbus alternating mattress replacement (1 in 2 alternating cycle) and cushion

2. Pegasus Cairwave alternating mattress replacement (1 in 3 alternating cycle) and cushion.

Both groups also had their pressure ulcers treated according to the Trust wound care formulary and the Tissue Viability nurses recommendations. Patients were turned according to the manufacturers recommendations: 4-hourly for those assigned to the Nimbus system and 8-hourly for those assigned to the Cairwave system or more often if requested by the participant or considered necessary by the nursing team


OutcomesCompleted study (healed, discharged or died) and comfort


NotesFull data extraction performed on personal correspondence from main author


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer-generated random numbers

Allocation concealment (selection bias)Low riskOpaque sealed envelopes used

Blinding (performance bias and detection bias)
All outcomes
High riskIt is impossible to blind participants or study personnel to treatment allocation as the differences in mattresses is visually evident. Outcome data for healing were collected by 3 research nurses. Monitoring of the data collection and protocol compliance was carried out by a team member who was 'blinded' to the statistical analysis. Comfort data were recorded by audit staff who were unaware of the differences in the mattresses

Incomplete outcome data (attrition bias)
All outcomes
High riskThe author gives results which include and exclude those who died, however there was significant loss due to participants dying or being discharged from hospital. This was not addressed.

Selective reporting (reporting bias)High riskThe main aim was to compare the efficacy of the equipment for healing pressure ulcers. It is not clear why the outcome is described in terms of "completed study"

Other biasUnclear riskNo record of gender mix in each group or severity of pressure ulcer on admission to study

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Allman 1987aHeels not included

Allman 1987bHeels not included

Andrews 1989Not RCT

Bates Jenson 1998Not RCT

Bell 1993Not RCT

Benbow 1995Not RCT

Bennett 1998Heels not included

Blanco Blanco 2002Not treatment study

Bliss 1966Not treatment study

Bliss 1967Not treatment study

Bliss 1995No separate heel data

Braniff-Matthews 1997Not treatment study

Branom 1999No separate heel data

Branom 2001Heels not included

Bridel-Nixon 1997Heels not included

Brown 2001Not treatment study

Caley 1994Heels not included

Chaloner 2000Not treatment study

Cheneworth 1994Controlled clinical trial, not random allocation

Clark 2002Not an RCT

Collins 2002Not treatment study

Conine 1990aNot treatment study

Conine 1990bNot treatment study

Crook 1998Not treatment study

Cullum 2001Review: retrieved to follow up references

Day 1990Not RCT

Day 1993Not RCT

De Keyser 1994Not RCT

Devine 1995aNo separate heel data

Devine 1995bNo separate heel data

Ernst 2009Review, retrieved to follow up references

Evans 2000No separate heel data

Ewing 1964Not RCT

Ferrell 1993Heel data not available

Fleischer 1997Not RCT

Goldstone 1982Not treatment study

Gray 1998Not treatment study

Greer 1988Not RCT

Groen 1999No heel data

Hardin 2000Not treatment study

Henn 2004Not RCT

Johnson 1991Not RCT

Knight 1999No separate heel data

Knowles 1999Not RCT

Land 2000Duplicate study, no heels in study

Laurent 1997Not treatment study

Lazzara 1991No separate heel data

Marchand 1993Not RCT

Melland 1998Not RCT

Moody 1993No separate heel data

Mulder 1994Heel data not available

Munro 1989No separate heel data

Osterbrink 2005No separate heel data

Phillips 2000No separate heel data

Price 1999Not treatment study

Regan 2009Review, retrieved to follow up references

Russell 1998Conference presentation of included study

Russell 2000aNo heels included

Russell 2003No separate heel data

Scott 1995Not RCT

Sharp 2007Not RCT

Smith 1995Review: retrieved to check references

Soppi 2004Not treatment study

Strauss 1991No healing outcomes

Taylor 1999Heel data not available

Tewes 1993Review, not retrieved as not English language

Thomas 2001aReview, retrieved for references

Thomas 2001bReview, retrieved for references

Thomas 2006Review, retrieved for references

Thomas 2007Review, retrieved for references

Whittingham 1999Not treatment

Yang 2007Review: tried to retrieve but unable to find translator

Young 1992Review, retrieved for references

 
Comparison 1. Nimbus system compared with Cairwave system

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Heel ulcer healed1113Risk Ratio (M-H, Fixed, 95% CI)1.49 [0.90, 2.45]

 
Table 1. Leeds Teaching Hospitals heel ulcer prevalence

YearTotal no. PUsNo. of heel PUs% of PUs on heel

20062746022%

20073338526%

20083367422%

200955710719%

 PU = pressure ulcer
 
Table 2. Patient assessment of mattress comfort

Q1aQ1bQ2N

Nimbus
(completed)
1.71 (± 0.68)2.48 (± 1.32)2.81 (± 0.96)29

Cairwave
(completed)
1.94 (± 0.82)2.04 (± 1.30)2.46 (± 0.92)24

Nimbus
(discontinued)
2.33 (± 1.81)2.25 (± 1.89)2.50 (± 1.0)4

Cairwave
(discontinued)
2.51 (± 1.04)3.50 (± 1.69)3.56 (± 1.12)8

 Q1 a and b refer to mattress comfort, Q2 asked about sleep. Results are mean comfort scores from visual analogue scale (± standard deviation). Results are from both heel ulcer and sacral ulcer participants. All results were not significant.