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. 2021 May 6;2021(5):CD013621. doi: 10.1002/14651858.CD013621.pub2

Whittingham 1999.

Study characteristics
Methods Study objective: not given
Study design: randomised controlled trial
Study grouping: parallel group
Duration of follow‐up: 12 months
Number of arms: 6
Single centre or multi‐sites: single centre
Study start date and end date: not described
Setting: elderly assessment unit
Participants Baseline characteristics
Inclusion criteria: at high risk of pressure sores (Waterlow) and dependent (Barthel); all patients admitted onto research mattresses were included, unless their skin had grade 3 (Stirling) or above pressure damage, or their skin condition deteriorated to grade 2/3 damage
Exclusion criteria: not given
Sex (M:F): not given
Age (years): not given
Baseline skin status: at high risk
Group difference: not given
Total number of participants: n = 309
Unit of analysis: individuals
Unit of randomisation (per patient): individuals
Interventions Intervention characteristics
Improtec (Spenco International)
  • Description of interventions: Improtec (Spenco International)

  • NPIAP S3I classification: non‐powered, reactive foam surface; insufficient information for specifying foam quality

  • Co‐interventions: not described

  • Number of participants randomised: not given

  • Number of participants analysed: not given


Pentaflex (Huntleigh Healthcare)
  • Description of interventions: Pentaflex (Huntleigh Healthcare)

  • NPIAP S3I classification: non‐powered, reactive foam surface; insufficient information for specifying foam quality

  • Co‐interventions: not described

  • Number of participants randomised: not given

  • Number of participants analysed: not given


Serendipity (Talley)
  • Description of interventions: Serendipity (Talley)

  • NPIAP S3I classification: non‐powered, reactive foam surface; insufficient information for specifying foam quality

  • Co‐interventions: not described

  • Number of participants randomised: not given

  • Number of participants analysed: not given


Softform
  • Description of interventions: Softform (Medical Support System)

  • NPIAP S3I classification: non‐powered, reactive foam surface; high specification foam according to Gray 1994

  • Co‐interventions: not described

  • Number of participants randomised: not given

  • Number of participants analysed: not given


Transwave
  • Description of interventions: Transwave (Karomed)

  • NPIAP S3I classification: non‐powered, reactive foam surface

  • Co‐interventions: not described

  • Number of participants randomised: not given

  • Number of participants analysed: not given


Vapourlux
  • Description of interventions: Vapourlux (Parkhouse)

  • NPIAP S3I classification: non‐powered, reactive foam surface; insufficient information for specifying foam quality

  • Co‐interventions: not described

  • Number of participants randomised: not given

  • Number of participants analysed: not given

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

  • Time points: 12 months

  • Reporting: partially reported

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

  • Definition (including ulcer stage): pressure sore incidence

  • Dropouts: not described

  • Notes (e.g. other results reported): overall pressure sore incidence 16.5% (range 7 to 16.7% according to mattress), and the majority were grade 1 to 2 (Stirling)


Time to pressure ulcer incidence
  • Not reported


Support‐surface‐associated patient comfort
  • Outcome type: unclear

  • Time points: 12 months

  • Reporting: partially reported

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

  • Definition: patient comfort ratings

  • Dropouts: not given

  • Notes: comfort ratings were similarly good for all 6 mattresses initially. However, this altered by the end of the 12 months.


All reported adverse events using allocated support surfaces
  • Not reported


Health‐related quality of life (HRQOL)
  • Not reported


Cost‐effectiveness
  • Not reported

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: unclear risk of bias because the sequence generation process was not described.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: no information provided.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Outcome group: all outcomes
Quote: "Data were collected by a single researcher"
Comment: unclear risk of bias because it is unclear if outcome assessment was blinded.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: no information provided.
Selective reporting (reporting bias) Unclear risk Comment: no information provided.
Other bias Unclear risk Comment: no information provided.