| Methods |
Design: 6‐week prospective, parallel‐group, randomised controlled study |
| Participants |
Health condition: elderly people with chronic pressure ulcers Sample size:
Randomisation: at participant level (more than 1 ulcer for some participants)§
-
Randomised (participants, n; ulcers, n): 63; not reported
Experimental 1: 23; not reported
Experimental 2: 20; not reported
Control: 20; not reported
-
Analysed (participants, n; ulcers, n): 63; not reported
Experimental 1: 23; not reported
Experimental 2: 20; not reported
Control: 20; not reported
Setting, country: nursing and care centre (number of sites: 3), Poland Inclusion criteria:
stage II, III and IV pressure ulcers of at least 0.5 cm2 (NPUAP classification)
older adults (60 years or more) with high risk of pressure ulcer development (< 14 points on Norton scale)
duration of pressure ulcers between 1 and 12 months
Exclusion criteria:
participants with medical conditions impeding wound healing
participants with cancer, electronic implants, malignancy, tunnelling, necrotic wound likely to involve osteomyelitis and in need of surgical intervention
Characteristics of pressure ulcer:
-
Experimental 1
Ulcer duration, mean (SD): 2.4 months (1.7)
Ulcer location (n): sacrum (11), greater trochanter (8), ischial tuberosity (4)
Ulcer stage (n): stage II (12), stage III (9), stage IV (2)
-
Experimental 2
Ulcer duration, mean (SD): 2.7 months (2.2)
Ulcer location (n): sacrum (13), greater trochanter (4), ischial tuberosity (3)
Ulcer stage (n): stage II (11), stage III (6), stage IV (3)
-
Control
Ulcer duration, mean (SD): 3.0 months (2.2)
Ulcer location (n): sacrum (13), greater trochanter (4), ischial tuberosity (3)
Ulcer stage, (n): stage II (13), stage III (6), stage IV (1)
Mean age (SD):
Experimental group 1: 79 years (8)
Experimental group 2: 80 years (11)
Control group: 78 years (12)
Gender:
§It is clearly stated that in participant with multiple pressure ulcer, all wounds were treated but only one pressure ulcer per participant was analysed. |
| Interventions |
Total groups in this study: three Experimental 1: cathodal ES group plus standard wound care (CG group)
Duration: 50 minutes per session; 1 session per day; 5 days a week; total 6 weeks
Electrode placement: one over the ulcer and the other on the healthy skin 20 cm away from ulcer
Device, manufacturer: Intelect Advanced Combo unit (Chattanooga, Tennessee USA)
Intensity of ES: sensory perception
Frequency: 100 Hz
Type of current: pulsed
Polarity: cathode over the ulcer for entire duration of the study
Experimental 2: cathodal and anodal ES group plus standard wound care (CAG group)
Duration: 50 minutes per session; 1 session per day; 5 days a week; total 6 weeks
Electrode placement: one over the ulcer and the other on the healthy skin 20 cm away from ulcer
Device, manufacturer: Intelect Advanced Combo unit (Chattanooga, Tennessee USA)
Intensity of ES: sensory perception
Frequency: 100 Hz
Type of current: pulsed
Polarity: cathode over the ulcer for first 5 days and then anode over the ulcer for entire duration of the study
Control: placebo ES group current plus standard wound care (PG group)
Standard wound care
|
| Outcomes |
Outcomes included in this review: presented as [name of outcome in review]‐ [name of outcome in study]
Surface area of pressure ulcer ‐ wound surface area (expressed in cm2)
Proportion of pressure ulcers healed ‐ pressure ulcers closed (expressed as numbers)
Complications/adverse events ‐ adverse event (expressed in descriptive format)
Rate of pressure ulcer healing ‐ percentage area reduction (expressed as percentage per 6 week)*
Not useable data§: presented as [name of outcome in review]‐ [name of outcome in study]
Time point included in this review: week 6 (end of intervention) * converted from percentage per 6 week to percentage per week § data are not extractable and therefore not comparable |
| Notes |
Withdrawals, (n; reason):
Funding source: all research activities were funded by the Academy of Physical Education, Poland Registry or published protocol: prospectively registered at Australian New Zealand Clinical Trials Registry (identifier ANZCTRN12614000992606) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: “….in the trial generated 4 blocks of 6 letters (combinations of A, B, and C) using computer software.” p779 |
| Allocation concealment (selection bias) |
Low risk |
Quote: “To conceal the allocation sequence, consecutively numbered, opaque, and sealed envelopes were used.” p779 |
| Blinding of participants (performance bias)
All outcomes |
Low risk |
Quote: “All patients, medical personnel, and researchers were blinded.” p779 |
| Blinding of personnel (performance bias)
All outcomes |
High risk |
Quote: “All patients….were blinded. The exception was the main investigator and principal physical therapist, who set the equipment to apply active or sham ES.” p779 |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: “The person responsible for wound surface area measurements and statistical analysis was blinded too.” p779 |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Comment: 6/63 (10%) dropouts |
| Selective reporting (reporting bias) |
Low risk |
Comment: all pre stated outcomes were reported |
| Other bias |
Low risk |
Comment: appears free of other bias |