| Methods |
RCT; participants randomised (only 1 wound per person)
Funding: industry funded ‐ Calgon Vestal Laboratories, manufacturer of foam dressing. Setting: hospital and care home with spinal injury
Duration of follow‐up 24 weeks (also reported at 3, 6, 12 (graph) weeks)
Unit of analysis: person (1 ulcer/person) |
| Participants |
38 participants with pressure ulcers. PU Stage: II (58% overall) and III (PU classification: Enterstomal Therapy)
Age: overall mean: 76, range 28‐78 years. Duration of ulcer: 58% for 2 months or less; range 0‐5 years. Ulcer size: not stated
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: 33/38 were people with spinal chord injury |
| Interventions |
Group 1: foam dressing ‐ Epi‐Lock (not in BNF); n = 24. Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline moist; n = 14. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 24 weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Unclear risk |
Sequence generation unclear ‐ not stated. Allocation concealment unclear ‐ no information on allocation concealment. Baseline comparability unclear ‐ no information. Rating: unclear |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Unclear who outcome assessor was |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 11/24 (45%) and (5 staff‐requested removal, 1 participant‐requested removal, 1 special bed treatment, 4 reactions to treatment). Group 2 ‐ 6/14 (43%) (2 died, 1 staff‐requested removal, 1 participant‐requested removal, 1 surgery, 1 reaction to treatment).
i.e. similar rate missing in both groups; high rate – more 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) |
| Other bias
additional |
Unclear risk |
Insufficient information to assess whether an important risk of bias exists |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: unclear selection bias, attrition bias
Comments: all assessed by same rater (a registered nurse), but no information on what she knew |
