Rees 1999.

Methods	RCT; participants randomised (> 1 wound per person, likely slowest healing wound selected) Funding: industry funded ‐ funded by Johnson & Johnson Inc. Setting: unclear Duration of follow‐up 16 weeks Unit of analysis: person (1 ulcer/person)
Participants	124 participants with pressure ulcers. PU Stage: 3 and 4 (PU classification: NPUAP) Age: mean (SD) group 1: 50 (13.6) years; group 2: 48 (13.1) years; group 3: 49 (12.5) years and group 4: 51 (18.3) years. Duration of ulcer: median (IQR) Group 1: 30 (43) weeks; group 2: 22 (32) weeks; group 3: 33 (40) weeks and group 4: 22 (52) weeks. Ulcer size: ulcer volume median (IQR): group 1: 19.6 (21.9) cm²; group 2: 16.6 (15.1) cm²; group 3: 17.2 (19.7) cm² and group 4: 17.6 (33.8) cm² Wound characteristics at baseline: no wounds infected; no wounds sloughy; no wounds necrotic; exudate not reported Comment: probably a community‐based study; ulcer selected that was likely to be the slowest healing; debridement to remove necrotic material and fibrin (slough)
Interventions	Group 1: hydrogel dressing ‐ carboxymethylcellulose vehicle gel (as placebo) + saline gauze; n = 31. Grouped intervention category: advanced dressing Group 2: ineligible intervention ‐ 100 µg / g of growth factor in sodium carboxymethylcellulose vehicle gel + saline gauze Group 3: ineligible intervention ‐ 300 µg / g of growth factor in vehicle gel + saline gauze Group 4: ineligible intervention ‐ 100 µg / g of growth factor in vehicle gel, twice daily + saline gauze Results available separately ‐ numbers calculated from % ‐ but results from groups 2‐4 were combined ( n = 93). Grouped intervention category: ineligible ‐ growth factor gel
Outcomes	Primary outcomes: proportion completely healed at 16 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 who outcome assessor was
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Missing data: Group 1 ‐ unclear but may be 0. Group 2 ‐ unclear but may be 1 (1 participant with 100 microg bid discontinued). i.e. similar rate missing in both groups; unclear rate
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) ‐ ulcer selected that was likely to be the slowest healing
Other bias additional	Unclear risk	Results calculated from percentages
ALL‐DOMAIN RISK OF BIAS	High risk	Rating: high Reasons: unclear selection bias; results calculated from percentages Comments: number of missing data unclear, assumed 0. Slight differences in duration of ulcer