Ho 2012.
| Methods | RCT, Computer‐generated randomisation, follow up 3 weeks | |
| Participants | 28 inpatients who had SCI and were receiving standard wound care for stage III and IV pelvic(coccygeal, ischial, or trochanteric region) pressure ulcers. Age older than 18 years, with no preserved sensory function in the area of the pressure ulcers, clinically clean wound area (i.e., no necrotic tissue, no odour, and no exudate or minimal serosanguinous exudate only), No surrounding erythema or other evidence of cellulitis, no tunnelling, no actual or possible connection to body cavities, and no fistula, no malignancy or vascular disease associated with the area of tissue breakdown, no significant active systemic disease, such as heart disease, renal failure, diabetes, or end‐stage cancer, pressure ulcers with maximum diameters of 3 to 15 cm at recruitment into the study, no antibiotic therapy for 7 days before recruitment into the study | |
| Interventions | Intervention group: Daily low‐pressure pulsatile lavage treatment with 1 L of normal saline at 11 psi of pressure Control group: Daily sham treatment: The lavage flow was directed into a washbasin positioned adjacent to the wound and not visible to the participants |
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| Outcomes | Baseline mean depth: Intervention: 2.4 (1.67 to 3.19) ‐ Control: 3.0 (2.16 to 3.84) Final mean depth: Intervention: 1.4 (0.59 to 2.20) ‐ Control: 2.5 (1.81 to 3.16) Baseline mean width: Intervention: 4.2 (3.15 to 5.15) ‐ Control: 4.5 (2.83 to 6.17) Final mean width, Intervention: 2.9 (1.92 to 3.78) ‐ Control: 3.0 (1.30 to 4.65) Baseline mean length: Intervention: 5.0 (3.92 to 6.02) ‐ Control: 5.1 (3.68 to 6.47) Final mean length, Intervention: 3.5 (2.47 to 4.54) ‐ Control: 4.9 (3.53 to 6.32) Baseline mean volume: Intervention: 10.7 (6.54 to 14.83) ‐ Control: 16.1 (10.56 to 21.69) Final mean volume: Intervention: 5.8 (2.79 to 8.79) ‐ Control: 12.4 (8.39 to 16.38) Difference between sample means: Depth (cm/wk) 0.24 (0.09 to 0.58) p<0.001 Width (cm/wk) 0.16 (0.06 to 0.39) p<0.0001 Length (cm/wk) 0.47 (0.18 to 1.12) p<0.0001 Volume (cm3/wk) 0.33 (0.13 to 0.80) p<0.001 |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: Computer‐generated randomisation table |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) Participants ‐ all outcomes | Low risk | Quote: Participants were unaware of the intervention assignments |
| Blinding (performance bias and detection bias) Blinding of personnel delivering intervention ‐ all outcomes | Unclear risk | Quote: The research nurse administering the intervention was aware of the group assignments |
| Blinding (performance bias and detection bias) Outcome assessors ‐ all outcomes | Low risk | Quote: Assessors were unaware of the intervention assignments |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | None excluded |
| Selective reporting (reporting bias) | Low risk | all outcomes alluded to in the paper are reported on |