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 |
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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 |
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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) |
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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 |