| 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
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
Health‐related quality of life (HRQOL)
Cost‐effectiveness
|
| 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. |