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

Houwing 2008.

Methods Trial design: RCT
Trial grouping: cluster
Ethics and informed consent: yes
 Follow‐up period: 4 weeks
Sample size estimate: no
ITT analysis: yes; number randomised: 79; number analysed: 79
Funding: not stated
Participants Inclusion criteria:
  • written informed consent was obtained from each participant. If the mental capability of the participant to decide on participation was uncertain, the legal representative of the participant was asked for consent

  • participants had to be able to participate for an evaluation for 4 weeks

  • participants had to rest on an anti‐PU mattress

  • participants had to be at high risk of developing PU according to the Braden scale using a cut‐off point of 20


Exclusion criteria:
  • patients who were treated with another, unrelated ointment or cream

  • people who were to undergo or had undergone surgery < 2 weeks prior

  • people with existing PU

  • people with dark skin because of difficulty in assessment


Pretreatment
  • men: 27.7% control; 25% placebo; 37.9% DMSO

  • not incontinent: 16.7% control; 6.3% placebo; 0% DMSO

  • age (median): 81.5 years control; 85 years placebo; 80.5 years DMSO

  • no significant differences in participant characteristics

Interventions Intervention group: massage using a "DMSO‐cream". This cream consisted of 5% dimethyl sulfoxide in Vaseline‐cetomacrogol cream, combined with a 30° position change. This procedure was repeated every 6 h for 4 weeks
Placebo: 3‐min massage of the buttock, heel, and ankle regions with an "indifferent" cream (Vaseline‐cetomacrogol) combined with a 30° position change. This procedure was repeated every 6 h for 4 weeks
Control: 30° position change, repeated every 6 h for 4 weeks
Outcomes PU incidence
  • Outcome type: dichotomous outcome

  • Reporting: fully reported

  • Unit of measure: numbers

  • Direction: lower is better

  • Data value: endpoint

Identification Sponsorship source: not stated
Country: the Netherlands
Setting: 8 nursing homes
Comments: no comments
Author's name: R Houwing
Institution: Department Dermatology, Deventer Ziekenhuis
Email: houwingr@dz.nl
Address: Department Dermatology, Deventer Ziekenhuis, The Netherlands
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Throw of a dice (additional information from the study author)
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Stated as double‐blind
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinded, quote: "presence of a pressure ulcer confirmed by two external observers"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk None excluded
Selective reporting (reporting bias) Low risk Outcome measure was the presence of a PU, this was reported by the study authors
Other bias Unclear risk There is no indication that the cluster design was accounted for in the analysis