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. 2017 Jun 22;2017(6):CD011947. doi: 10.1002/14651858.CD011947.pub2

Romanelli 2001.

Methods RCT (abstract); participants randomised (unclear if > 1 wound per person)
 Funding: not stated. Setting: not stated
 Duration of follow‐up 8 weeks
 Unit of analysis: unclear
Participants 12 participants with pressure ulcers. PU Stage: 2 and 3 (proportions not stated) (PU classification: EPUAP)
 Age: not stated. Duration of ulcer: not stated. Ulcer size: not stated
 Wound characteristics at baseline: infection not reported; slough not reported; necrosis not reported; exudate not reported
Interventions Group 1: hydrogel dressing ‐ DuoDERM Hydrogel (not in BNF): with OpSite Flexigrid secondary dressing; n = 6. Grouped intervention category: advanced dressing
 Group 2: topical ‐ tripeptide‐copper gel + OpSite; n = 6. Grouped intervention category: tripeptide‐copper
Outcomes Primary outcomes: proportion completely healed at 8 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 ‐ 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 Unclear risk Missing data: Group 1 ‐ 0 (implied). Group 2 ‐ 0 (implied)
 i.e. unclear if data missing; unclear rate
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 unclear ‐ 1 ulcer per person implied
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 attrition, unclear blinding (abstract); preliminary results
 Comments: abstract ‐ few details