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. 2018 Dec 6;2018(12):CD009362. doi: 10.1002/14651858.CD009362.pub3

Nakagami 2007.

Methods Trial design: RCT
Trial grouping: within‐participant (participant acting as their own control)
Ethics and informed consent: yes
Follow‐up period: 3 weeks
Sample size estimate: yes, the estimated sample size was 33, and therefore 37 participants were enrolled, assuming a loss to follow‐up of 10%
ITT analysis: yes; number randomised: 37; number analysed: 37
Funding: this study was supported by a Grant‐in‐Aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology, Japan [(B) (2) 16390637]
Participants Inclusion criteria:
  • aged ≥ 65

  • Braden score of < 15


Exclusion criteria:
  • impaired judgement

  • lack of consciousness

  • presence of a PU or skin disorder in the study area

  • poor general medical condition

  • inability to position the body in either a right or left lateral position


Pretreatment
  • age, years, mean (SD): 86.4 ± 8.2

  • women: 28 (75.7%)

  • Braden score, mean (SD): 10.4 ± 1.2

  • bedridden: 37 (100%)

  • body weight: 11 kg, mean (SD): 36.6 ± 2.8

  • no support surfaces: 11 (29.7%)

  • diagnosis: cerebrovascular disease: 30 (81.1%); heart disease: 10 (27.0%); diabetes mellitus: 4 (10.8%)

Interventions Intervention group:
  • PPD (dressing with skin adhesive layer (hydrocolloid), a support layer (urethane film) and an outer layer of multi filament nylon fibres

  • applied to either the right or the left trochanter

  • PPD replaced every week


Control group:
  • participants acted as their own control, i.e. no dressing was applied to the opposite trochanter

Outcomes PU incidence
  • Outcome type: dichotomous outcome

  • Reporting: fully reported

  • Unit of measure: numbers

  • Direction: lower is better

  • Data value: endpoint


Incidence of persistent erythema
  • Outcome type: dichotomous outcome

  • Reporting: fully reported

  • Unit of measure: numbers

  • Direction: lower is better

  • Data value: endpoint

Identification Sponsorship source: not stated
Country: Japan
Setting: 500‐bed geriatric hospital
Comments: no comments
Author's name: G Najagami
Institution: Division of Health Sciences and Nursing, Graduate School of Medicine
Email: not provided
Address: University of Tokyo, Tokyo, Japan
Notes PU classification system not clearly described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded, quote: “impossible due to the type of intervention”
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not blinded, quote: "test area outlined so that the dressing applied back to the same area"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT conducted
Selective reporting (reporting bias) Low risk All outcomes reported in the paper were those outlined by the study authors
Other bias High risk Investigators were part of the group that developed the PPD