| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: non‐industry funding ‐ declaration of interest: none. Setting: hospital with spinal chord injury
Duration of follow‐up unclear weeks
Unit of analysis: ulcer |
| Participants |
27 participants with pressure ulcers. PU Stage: 1 (24% and 25% of ulcers), 2 (68% and 71%) and 3 (results separate, but best to combine) (PU classification: NPUAP)
Age: mean (SD): 35.3 (14.6), range 16‐56 years and 29.7 (6.4), range 17‐39 years. Duration of ulcer: not stated. Ulcer size: mean (SD): 4.13 (2.73; range: 2‐13) cm²; reporting of control group unclear: range 2‐35 cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: spinal chord injury (78% complete, 22% incomplete SCI); 15 participants/25 ulcers and 12 participants/24 ulcers |
| Interventions |
Group 1: hydrogel dressing ‐ Elastogel (not in BNF); n = 15. Grouped intervention category: advanced dressing
Group 2: iodine containing dressing ‐ povidone iodine soaked gauze; n = 12. Grouped intervention category: antimicrobial dressing |
| Outcomes |
Primary outcomes: complete healing not reported; time to complete healing not reported |
| 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 adequate ‐ no suggestion of problems. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear ‐ no information |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 0. Group 2 ‐ 0; i.e. no missing data (no details) |
| 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 ‐ for combination of stages I and II and III, ulcer:person ratio = 25/15 (1.7) and 24/12 (2.0) |
| Other bias
additional |
Unclear risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Comments: unclear selection bias, unclear blinding; unit of analysis issues |
