Zeron 2007.
| Methods | RCT; participants randomised (only 1 wound per person) Funding: unclear ‐ product supplied by Aspid. Setting: hospital inpatients Duration of follow‐up 3 weeks Unit of analysis: person (1 ulcer/person) | |
| Participants | 24 participants with pressure ulcers. PU Stage: 2 and 3 (PU classification: NPUAP) Age: mean 79.8 years and 78.3 years. Duration of ulcer: not stated. Ulcer size: diameter mean (SD): 3.4 (1.2) cm and 2.9 (1.3) cm Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported Comment: IPD reported | |
| Interventions | Group 1: protease‐modulating dressing ‐ Fibroquel: collagen plus polyvinylpyrrolidone + zinc oxide paste cleansing; n = 12. Grouped intervention category: protease‐modulating dressing Group 2: polyvinylpyrrolidone (PVP + zinc oxide paste cleansing); n = 12. Grouped intervention category: basic dressing | |
| Outcomes | Primary outcomes: proportion completely healed at 3 weeks; time to complete healing not reported | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Selection bias | Unclear risk | Sequence generation adequate ‐ random number tables. 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 who outcome assessor was |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data: Group 1 ‐ none. Group 2 ‐ none. i.e. no missing data (clearly stated) |
| Selective reporting (reporting bias) | Unclear risk | Unclear reporting |
| 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 | Unclear risk | Rating: unclear Reasons: unclear selection bias, unclear who outcome assessor was, unclear reporting of numbers healed (but not a problem) Comments: healing data not reported explicitly, but deduced from IPD on ulcer size (number with zero size) |
AHRQ: US Agency for Healthcare Research and Quality BNF: British National Formulary HC: hydrocolloid IPD: individual participant data NPWT: negative pressure wound therapy NS: not stated RCT: randomized controlled trial UV: ultraviolet