| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: non‐industry funding ‐ study was funded by the John Labatt Seed Fund Award. Setting: hospital with spinal chord injury
Duration of follow‐up could choose (IPD) e.g. Results given at 8 (reviewer choice) weeks (also reported at various times from IPD graph weeks).
Unit of analysis: ulcer |
| Participants |
20 participants with pressure ulcers. PU Stage: not stated (PU classification: not stated)
Age: mean (range): 36 (15‐46) years; 42.2 (26‐59) years; 42 (30‐61) years. Duration of ulcer: > 6 weeks 67%, 100%, 100%, < 1 week 33%, 0%, 0%. Ulcer size: not stated
Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported
Comment: people with spinal chord injury (younger people) |
| Interventions |
Group 1: basic wound contact dressing ‐ paraffin gauze (Jelonet); n = 9. Grouped intervention category: basic dressing
Group 2: ineligible intervention ‐ ultrasound + UV (US/UV + Jelonet); n = 5. Grouped intervention category: ineligible ‐ ultrasound + UV
Group 3: laser ‐ laser + Jelonet (laser + Jelonet; n = 6). Grouped intervention category: ineligible ‐ laser |
| Outcomes |
Primary outcomes: proportion completely healed at could choose (IPD) e.g. Results given at 8 (reviewer choice) weeks; time to complete healing reported (Kaplan Meier plot included) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation unclear ‐ “randomised”. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinded to interventions (clear description) |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 3/9 (33%) (2 elected to have wounds surgically repaired and withdrew; 1 transferred to acute hospital). Group 2 ‐ 0. Group 3 ‐ 1/6 (17%) (1 transferred to acute hospital).
i.e. differential missing data rates; high differential rate – likely to change effect estimate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
High risk |
Unit of randomisation person and unit of analysis ulcer ‐ IPD reported per ulcer (but only 2/16 (12.5%) participants had 2 ulcers); ≤ 1.2 ulcer:person = 9/9, 6/5 and 7/6 |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: very high
Reasons: unclear selection bias, attrition bias, unit of analysis issues
Comments: PU grade not reported. Baseline characteristics: laser group had 2/6 deeper ulcers (6‐10 mm), other ulcers all shallower; control group had 2/6 acute ulcers |
| ALL‐DOMAIN RISK OF BIAS 2 |
High risk |
|
