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

Carley 1985.

Methods Design: 5‐week randomised controlled study
Participants Health condition: elderly people with indolent pressure ulcers
Sample size:
  • Randomisation: at participant level (one ulcer per participant)§

  • Randomised (participants, n; ulcers, n): 30; 30

    • Experimental: 15; 15

    • Control: 15; 15

  • Analysed (participants, n; ulcers, n): 30; 30

    • Experimental: 15; 15

    • Control: 15; 15


Setting, country: Spaulding Rehabilitation Hospital (1 site), Boston, USA
Inclusion criteria:
  • inpatients

  • pressure ulcer located either below the knee or over the sacral area


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

    • Ulcer duration, mean (SD): 8.6 months (3.7)

    • Ulcer location: below knee and/or over sacral region (number not reported)

    • Ulcer stage: not reported

  • Control

    • Ulcer duration, mean (SD): 5.2 months (2.9)

    • Ulcer location: below knee and/or over sacral region (number not reported)

    • Ulcer stage: not reported


Mean age (SD):
  • Experimental: 70 years (18)

  • Control: 74 years (14)


Gender:
  • Experimental: 53% male

  • Control: 47% 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: LIDC plus cointervention
  • Duration: 2 hours per session; 2 sessions per day (2 to 4 hours pause between 2 sessions); 5 days a week; total 5 weeks or until healed

  • Electrode placement: one over the ulcer (active electrode) and the other 15‐20 cm away from the ulcer (dispersive electrode)

  • Device, manufacturer: Portable Direct Current Stimulator, AGAR Israel

  • Intensity of ES: not reported

  • Frequency: not applicable (direct current)

  • Type of current: direct

  • Polarity:

    • active electrode with negative polarity for first 3 days

    • then dispersive electrode with negative polarity until the ulcer was healed or the healing plateaued

    • the above protocol was restarted if healing plateaued


Control: conventional wound therapy plus cointervention
  • This included wet to dry gauge dressings, solution soaked dressings and few received whirlpool therapy for 5 times a week.


Cointervention for both groups
  • All ulcers were debrided before delivering any intervention.

Outcomes Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]
  • Complications/adverse events‐ adverse events (expressed in descriptive format)


Other outcomes not included in this review:
(1) "area measurement" (i.e. volume) of the ulcer (expressed as cm3)
Time point included in this review: week 5 (end of intervention)
Other time points: baseline, week 1, week 2, week 3 and week 4
Notes Withdrawals, (n; reason):
  • Experimental: none

  • Control: none


Funding source:
  • parts for experimental direct current generators and electronic support, AGAR, Kibbutz Ginosar, Israel

  • electrode materials and supplies, KIM ED Industries Inc., New York, USA


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 to LIDC" p443
 Comment: insufficient detail reported
Allocation concealment (selection bias) Unclear risk Comment: insufficient detail reported
Blinding of participants (performance bias) 
 All outcomes High risk Quote: "Conventional wound therapy" p443
 Comments: not possible to blind participants
Blinding of personnel (performance bias) 
 All outcomes High risk Comments: not possible to blind personnel
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "Area measurement of length, width, and depth to within the nearest millimetre were performed by the nursing staff and recorded without previous knowledge" p444
 Comment: not clear if assessor was blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no dropouts
Selective reporting (reporting bias) Low risk Comment: all pre stated outcomes were reported
Other bias Unclear risk Comment: trial was sponsored by third parties who were likely to have a vested interest in a positive finding