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. 2018 Sep 1;2018(9):CD012841. doi: 10.1002/14651858.CD012841.pub2

Moffatt 2014a.

Methods Cohort comprised participants in the intervention arm of an RCT of oxyzyme/iodozyme vs control (usual treatment)
Setting: community leg ulcer service
Country: UK
Duration of follow‐up: 12 weeks
Treatments: oxyzyme/iodozyme plus secondary dressing (film, surgipad/thin foam according to exudate level). All used appropriate compression
Participants 47 participants with VLU or arterial leg ulcers (26 VLU, 21 mixed A‐V)
Mean age: 69.7 (SD 13.2) years; similar for both groups
Sex (M:F): 23:24
Stage of ulcer: not reported
Ulcer duration: mean: 17.6 (SD 40.3) months
Ulcer size at baseline: mean 8.1 (SD 10.2) cm²
Wound infection: no cellulitis (exclusion criteria), but wound infection not mentioned
Number of wounds: unclear (1 limb per participant but (overall) 13 noted as having ulcer on contralateral limb so possibly 113 wounds)
Inclusion criteria: aged ≥ 18 years, venous (ABPI > 0.8) or mixed (ABPI > 0.6) ulcer 2‐50 cm², mild or moderate exudate, healthy peri‐wound skin
Exclusion criteria: pregnancy, breastfeeding, acute DVT within 3 months, surgery for chronic venous insufficiency within 2 months, surgery for peripheral arterial occlusive disease within 3 months, cellulitis, thyroid treatment, known hypersensitivity to components of new dressings; peri‐wound maceration or uncontrolled varicose eczema around the ulceration
Prognostic factors MMP (unspecified) (dichotomous data); MMP activity. Measurement method enzyme detection device for detecting or measuring the presence in a test sample of the activity of an enzyme capable of cleaving a substrate: reverse ELTABA (Mologic Ltd.)
Time of measurement: baseline
Wound fluid sampling method: swabs (taken at dressing change)
Notes Results reported separately for the 2 randomised groups because oxyzyme/iodozyme suggested to be protease modulating
Risk of bias
Bias Authors' judgement Support for judgement
Selection bias Low risk All participants considered who met the inclusion criteria
Attrition bias Unclear risk Moderate: 6/47 (13%) participants discontinued in intervention group; unclear if important
Prognostic factor measurement Unclear risk Moderate: cut‐off defined on 0‐10 scale; unclear if validated: score of ≥ 5 considered to be high protease activity
Outcome measurement High risk Not blinded, investigator present at all times and assessed the outcome
Adjustment factors High risk None of the key adjustment factors taken into account in the design or analysis
Analysis and reporting High risk Possible interaction with treatment (which proposed to be protease modulating); not taken into account in analysis
Overall risk of bias High risk