| Methods |
RCT; participants randomised (> 1 wound per person, other selection of wound)
Funding: industry funded ‐ grant from Carrington labs Inc (hydrogel manufacturers). Setting: care home and community
Duration of follow‐up 10 weeks
Unit of analysis: person (1 ulcer/person) |
| Participants |
41 participants with pressure ulcers. PU Stage: II (50% and 43%), III (38% and 50%) and IV (13% and 7%) (PU classification: not stated)
Age: mean (SD): 79 (9) years and 72 (13) years. Duration of ulcer: not stated. Ulcer size: mean (SD): 8.9 (9.3) cm² and 5.9 (6.0) cm²
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported |
| Interventions |
Group 1: hydrogel dressing ‐ Carrosyn Gel Wound Dressing (contains Acemannan hydrogel ‐ from aloe vera); n = 22. Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline moist; n = 19. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 10 weeks; 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 unclear ‐ baseline difference but unclear of importance. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear ‐ vague |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ 6/22 (27%) (4 died (not attributed to treatment), 1 showed deterioration and was terminated from study, 1 participant hospitalised). Group 2 ‐ 5/19 (26%) (2 died (not attributed to treatment), 1 showed deterioration and was terminated from study, 1 participant hospitalised, 1 protocol violation)
i.e. similar rate missing in both groups; low rate ‐ less than control event rate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation person and unit of analysis person (1 ulcer/person) ‐ 1 per person; NS how selected |
| Other bias
additional |
Low risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
Unclear risk |
Rating: unclear
Reasons: unclear selection bias; unclear blinding
Comments: baseline difference in ulcer size (8.9 cm² and 5.9 cm², but not significant); unclear if outcome assessors were blinded ‐ "study nurses who evaluated weekly" |
