| Methods |
RCT; ulcers randomised (> 1 wound per person, all followed)
Funding: not stated. Setting: hospital inpatients
Duration of follow‐up 6 weeks (also reported at 12 for time to event weeks)
Unit of analysis: ulcer |
| Participants |
50 participants with pressure ulcers. PU Stage: not stated and no indication apart from mean depth (PU classification: not stated)
Age: mean 83.6 (SD 9.2) and 83.4 (SD 9.4). Duration of ulcer: 4.6 (SD10.9) and 4.8 (SD 6.5). Ulcer size: median (range?) 2.02 (0.95, 3.10) and 2.44 (0.97, 3 .24)
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: "considerable amount of debris" |
| Interventions |
Group 1: hydrocolloid dressing ‐ Comfeel Ulcus (not in BNF): 1 week washout with saline gauze; then hydrocolloid sheet and, if appropriate, hydrocolloid paste (7) and powder (1 ulcer); dressings changed when necessary; n = total 50 (number per group not reported). Grouped intervention category: advanced dressing
Group 2: gauze saline dressing ‐ saline wet (1 week washout with saline gauze; then saline gauze changed twice/day); n = total 50 (number per group not reported). Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: complete healing not reported; 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 of unclear 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 |
Unclear risk |
Missing data: not reported by group and very unclear overall ‐ possibly 9/50 (18%) missing (1 died, 2 protocol violations, 2 results missing, 3 discontinued for surgery, 1 adverse event) |
| Selective reporting (reporting bias) |
High risk |
Inadequate – reported incompletely (e.g. P value > 0.05) |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation ulcer and unit of analysis ulcer ‐ 6/50 participants had 2 pressure ulcers (2 participants had 1 ulcer assigned to each group); ulcer:person = 60/56 overall = 1.12 |
| 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; unclear missing data; unclear if PU grade sufficient; main outcome results estimated
Comments: very poorly reported study; PU stage not stated; main outcomes estimated; ulcers randomised and analysed, so no unit of analysis errors; stated to be some baseline differences in ulcer duration, but degree and importance unclear |
