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. 2020 Jan 22;2020(1):CD012196. doi: 10.1002/14651858.CD012196.pub2

Karba 1995.

Methods Design: parallel randomised controlled study
Participants Health condition: people with spinal cord injury
Sample size:
  • Randomisation: at participant level (one ulcer per participant)§

  • Randomised (participants, n; ulcers, n): 12; 12

    • Experimental: 6; 6

    • Control: 6; 6

  • Analysed (participants, n; ulcers, n): 12; 12

    • Experimental: 6; 6

    • Control: 6; 6


Setting, country: inpatient department (1 site), Slovenia
Inclusion criteria:
  • male participants with spinal cord injury who had developed a pressure ulcer


Exclusion criteria: not reported
Characteristics of pressure ulcer:
  • Experimental

    • Ulcer duration: not reported

    • Ulcer location: not reported

    • Ulcer stage: not reported

  • Control

    • Ulcer duration: not reported

    • Ulcer location: not reported

    • Ulcer stage: not reported


Age (range):
  • Overall: 29 to 42 years

  • Experimental: not reported

  • Control: not reported


Gender:
  • Overall: 100% male


§It is not clearly stated whether participants or pressure ulcers were randomised but the number of pressure ulcers equals the number of participants.
Interventions Total groups in this study: two
Experimental: ES group and standard care
  • Duration: 120 minutes per day; until healed

  • Electrode placement: healthy skin at ulcer edge

  • Device, manufacturer: Encore Tm Plus, Axelgaard Manufacturing, Ltd. USA

  • Intensity of ES: visible contraction of the muscles in the wound area

  • Frequency: not reported

  • Type of current: pulsed

  • Polarity: not reported


Control: CO group
  • Sham with no ES delivered


Standard care for both groups
  • Cleaning with a physiological solution and covering with semi‐occlusive foam gel dressings. The dressings were changed as necessary or at the latest after one week.

Outcomes Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]
  • Surface area of pressure ulcers ‐ wound area (expressed as mm2)*

  • Rate of pressure ulcer healing ‐ relative healing rate (expressed as percentage per day)


Time point included in this review: until healed†
Other time points: baseline
*converted to cm2 for the purpose of analyses
†data were captured at varying time points (between 10 and 56 days); we extracted the data for 2 weeks before participants in the control group were crossed to experimental group
Notes Withdrawals, (n; reason):
  • Experimental: none

  • Control: none


Funding source: this study was supported by:
  • Ministry of Science and Technology of the Republic of Slovenia

  • Johnson & Johnson S.E. Inc., Ljubljana, Slovenia for providing the wound dressings


Trial registration or published protocol: no information about trial registration or published protocol provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned" p671
 Comment: insufficient detail reported
Allocation concealment (selection bias) Unclear risk Comment: insufficient detail reported
Blinding of participants (performance bias) 
 All outcomes Low risk Quote: control participants received "sham treatment". p671
Blinding of personnel (performance bias) 
 All outcomes Unclear risk Comment: insufficient detail reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient detail reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no dropouts. All data are available in Table 2
Selective reporting (reporting bias) Low risk Comment: all pre stated outcomes were reported
Other bias High risk Comment:
  • Participants in the control group were crossed to experimental group at varying time points (between 10 and 56 days)

  • Trial was sponsored by third parties who were likely to have a vested interest in a positive finding