| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: not stated. Setting: care home
Duration of follow‐up 4 weeks
Unit of analysis: results for both people and ulcers |
| Participants |
17 participants with pressure ulcers. PU Stage: not stated (PU classification: not stated)
Age: range 28‐59 years, 29‐57 years and 32‐70 years. Duration of ulcer: not stated. Ulcer size: collagenase: 10.24 cm²; dextranomer: 20.25 cm² and sugar + egg white 5.76 cm²
Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported
Comment: assumed that all ulcers in a participant had to heal before a participant was healed |
| Interventions |
Group 1: collagenase‐containing ointment ‐ collaganese: ointment applied with wooden applicator and covered with a dry dressing; n = 5. Grouped intervention category: collagenase ointment
Group 2: dextranomer ‐ dextranomer (dextranomer beads poured into the ulcer and covered with dry dressing); n = 7. Grouped intervention category: dextranomer
Group 3: sugar + egg white ‐ sugar + egg white applied to the area 4 times/d (sugar + egg white applied to the area 4 times/d; n = 5. Grouped intervention category: sugar + egg white |
| Outcomes |
Primary outcomes: proportion completely healed at 4 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 |
Low risk |
Missing data: Group 1 ‐ none. Group 2 ‐ none. Group 3 ‐ none
i.e. no missing data (no details) |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
Unclear risk |
Unit of randomisation person and unit of analysis results for both people and ulcers ‐ we used the results for the participants, but unclear what was meant by healing => unclear risk of bias |
| 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 unit of analysis issues
Comments: says participants and investigators were blinded and nurses looked after participants => implies outcome assessors were investigators. Baseline differences said to be not statistically significant in area of ulcer |
