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. 2021 May 10;2021(5):CD013620. doi: 10.1002/14651858.CD013620.pub2

Jiang 2014.

Study characteristics
Methods Study objective: to investigate the efficacy of static low‐air‐loss mattress (static LALM) and power pressure air mattress (PPAM) in prevention of pressure ulcers
Study design: randomised controlled trial
Study grouping: parallel group
Duration of follow‐up: 5 days after surgery
Number of arms: 2
Single centre or multi‐site: multi‐site
Study start date and end date: not described
Setting: hospitals
Participants Baseline characteristics
Inclusion criteria: age ≥ 18 years, male or female with Braden score ≤ 16 points, general anaesthesia for surgery with operating time ≥ 120 min, admitted to the intensive care unit (ICU) or surgical wards after surgery, clear consciousness, able to express their feelings correctly, had contraindications for using air mattress (doctor’s orders: lying on hard‐bed or flat‐bed), completed informed consent and related information
Exclusion criteria: refused to participate in research; in critical condition and repositioning limited by doctor’s orders; using ice blanket; shed from intervention less than 72 hours; unable to determine the efficacy; incomplete data on the efficacy; or safety judgment.
Sex (M:F): overall 621:453
Age (years): overall mean 57.94 (SD 15.54) years (range 18 to 88)
Baseline skin status: overall mean Braden scores 13.15 (SD 2.25) (range 6 to 17)
Group difference: no difference
Total number of participants: n = 1074
Unit of analysis: individuals
Unit of randomisation (per patient): individuals
Interventions Intervention characteristics
Static air mattress
  • Description of interventions: static air mattress (®WAFFLE static air mattress, EHOB, United States)

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

  • Co‐interventions: repositioning every 2 hours

  • Number of participants randomised: n = 562

  • Number of participants analysed: n = 562


Dynamic air mattress
  • Description of interventions: dynamic air mattress (Sanma mattress manufacturing factory, Shanghai, China)

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

  • Co‐interventions: repositioning every 2 hours

  • Number of participants randomised: n = 512

  • Number of participants analysed: n = 512

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

  • Time points:

  • Reporting: partially reported

  • Measurement method (e.g. scale, self‐reporting): graded by the NPIAP 2007 criteria

  • Definition (including ulcer stage):

  • Dropouts: no missing

  • Notes (e.g. other results reported): static air mattress group 1.07% (6/562); dynamic air mattress 0.98% (5/512) χ2 = 0.148, P = 0.882


Time to pressure ulcer development
  • Not reported


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

  • Time points: post‐operative 5 days

  • Reporting: partially reported

  • Measurement method (e.g. scale, self‐reporting): asking patients’ feelings after using the mattress 1 = very uncomfortable, 2 = uncomfortable, 3 = just comfortable, 4 = comfortable, 5 = very comfortable

  • Definition: the level of patients’ comfort

  • Dropouts: 80 of 562 missing in static air mattress; 100 of 562 missing in dynamic air mattress

  • Notes: 68 of 482 patients having a comfort level rating more than the median of 4 in static air mattress and 414 of 482 less than the median level; 68 of 462 more than the median of 4 in dynamic air mattress and 394 less than the median (Chi2 = 0.071, P = 0.789)


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) Low risk Quote: "We used a random number table to randomize and parallel control design"
Comment: low risk of bias because the sequence generation process is proper.
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 Comment: no information provided.
Incomplete outcome data (attrition bias)
All outcomes Low risk Outcome group: ulcer incidence
Comment: low risk of bias because intention‐to‐treat (ITT) analysis performed.
Outcome group: comfort
Comment: unclear risk of bias because the rates of missing data in both groups are between 10% to 20%.
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.