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. 2021 May 6;2021(5):CD013623. doi: 10.1002/14651858.CD013623.pub2

Daechsel 1985.

Study characteristics
Methods Study objective: to assess 2 commonly used special mattresses in a randomised trial involving adult non‐geriatric chronic neurologic patients
Study design: randomised controlled trial
Study grouping: parallel group
Duration of follow‐up: 3 months
Number of arms: 2
Single centre or multi‐sites: single centre
Study start date and end date: not described
Setting: long‐term care hospital for chronic neurologic conditions
Participants Baseline characteristics
Inclusion criteria: consenting patients in a long‐term care hospital for chronic neurologic conditions ... a) between 19 and 60 years of age, b) free of any evidence of skin breakdown two weeks prior to the study, and c) considered to be at high risk of developing pressure ulcers based on assessments conducted by the ward team [Norton scale score of 14 or less; and clinical judgement]
Exclusion criteria: none
Sex (M:F): 10:6 in alternating air mattress; 6:10 in Silicore mattress
Age (years): mean 42.6 (SD 13.7) in alternating air mattress; 38.5 (13.82) in Silicore mattress
Baseline skin status: mean Norton score 13.35 (SD 1.86) in alternating air mattress; 12.97 (2.28) in Silicore mattress.
Group difference: no difference
Total number of participants: 32
Unit of analysis: individuals
Unit of randomisation (per patient): individuals
Interventions Intervention characteristics
Alternating air mattress
  • Description of interventions: "... consisted of an electrically driven pump connected to a heavy‐duty plastic mattress ... composed of honey combed 4‐inch air cells, which alternately inflate and deflate when in operation ... placed over a standard hospital spring mattress or 4‐inch foam mattress and supported by a standard hospital bedframe"

  • NPIAP S3I classification: powered, alternating pressure (active) air surface

  • Co‐interventions: usual care including repositioning and additional preventive aids (including heel and ankle protectors, sheepskins and bed cradles)

  • Number of participants randomised: n = 16

  • Number of participants analysed: n = 16


Silicore mattress
  • Description of interventions: "a reversible mattress composed of siliconized hollow fibers in an interwoven mesh that accommodates the body surface and decreases pressure ... placed over a standard hospital spring mattress or 4‐inch foam mattress and supported by a standard hospital bedframe"

  • NPIAP S3I classification: non‐powered, reactive fibre‐filled surface

  • Co‐interventions: usual care including repositioning and additional preventive aids (including heel and ankle protectors, sheepskins and bed cradles)

  • Number of participants randomised: n = 16

  • Number of participants analysed: n = 16

Outcomes Proportion of participants developing a new pressure ulcer
  • Outcome type: binary

  • Time points: 3 months

  • Reporting: fully reported

  • Measurement method (e.g. scale, self‐reporting): measured by 1 investigator using the Exton‐Smith scale

  • Definition (including ulcer stage): skin condition of degrees of ulcers graded on the Exton‐Smith scale (0 = none, 1 = persistent erythema, 2 = localised blister, 3 = superficial sore, 4 = deep sore, 5 = extensive gangrenous sore)

  • Dropouts: no dropouts

  • Notes (e.g. other results reported): 4 of 16 individuals in alternating air mattress; 4 of 16 in Silicore mattress. Severity of ulcers graded and numbers by grade not reported and not extracted.


Time to pressure ulcer incidence
  • Reporting: not reported


Support‐surface‐associated patient comfort
  • Time points: 3 months

  • Reporting: partially reported

  • Measurement method (e.g. scale, self‐reporting): not reported

  • Notes: "the patients did not indicate a particular like or dislike of the type of mattress to which they were assigned"


All reported adverse events using allocated support surfaces
  • Reporting: not reported


Health‐related quality of life (HRQOL)
  • Reporting: not reported


Cost‐effectiveness
  • Reporting: not reported


Outcomes that are not considered in this review but reported in trials:
  • Equipment condition

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "All were randomly assigned to one of the two types of mattresses"
Comment: the method of randomisation was not described.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Outcome group: primary outcome
Comment: no information provided.
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcome group: primary outcome
Quote: "one of the investigators (DD) conducted weekly skin checks of the subjects"
Comment: high risk of bias for pressure ulcer incidence outcome because it is unlikely that the investigator who assessed skin conditions was blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcome group: primary outcome
Quote: "Thirty‐two patients met the criteria for this study ... all admitted to the trial and completed it"
Comment: no missing data.
Selective reporting (reporting bias) Low risk Comment: the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified.
Other bias Low risk Comment: the study appears to be free of other sources of bias.