Skip to main content
. 2018 Sep 1;2018(9):CD012841. doi: 10.1002/14651858.CD012841.pub2

Harris 1995.

Methods Nested case‐control design in a cross‐sectional study: wounds divided on clinical criteria into those in granulating/epithelialising and non‐granulating phases
Setting: not reported
Country: UK
Duration of follow‐up: none, case‐control
Treatments: not reported
Participants 18 participants with VLUs (area 8.5‐75 cm²; duration, 6 months ‐ 40 years)
Mean age: 73 (SD 12) years (calculated from IPD)
Sex: not reported
Stage of ulcer: not reported
Ulcer duration: mean: 14 (SD 13) years (calculated from IPD)
Ulcer size at baseline: mean: 31 (SD 18) cm² (calculated from IPD)
Wound infection: none (all confirmed as not clinically infected)
Number of wounds 18 (presumed)
Inclusion criteria: not explicitly stated but VLUs of > 6 months' duration were included
Exclusion criteria: not reported
Prognostic factors MMP (unspecified) (continuous data); collagenases (unspecified); total activity (μg collagen degraded/hour/mg protein in fluid); also reported separately for latent and active. Measurement method was ³H‐labelled type 1 collagen assay: trypsin was added (to cleave latent MMP to active MMP) and the net total activity measured, endogenous inhibitors of collagenase not removed (active collagenase was also measured without trypsin treatment)
Time of measurement: baseline
Wound fluid sampling method: occlusive dressings (Tegaderm dressing, 4‐6 hours (foam))
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Selection bias High risk No details on selection; wounds were classified into healing and non‐healing within a cohort of participants; not matched and longitudinal features not reported.
Attrition bias Unclear risk Moderate: 2/12 participants in non‐healing group missing. Unclear if this was important
Prognostic factor measurement Unclear risk Moderate: MMP type not specified. 1995 study; unclear if measurement appropriate and insufficient details
Outcome measurement High risk Type of case‐control study; healing and non‐healing identified, but not matched at the outset
Adjustment factors Unclear risk Moderate: at least half, but not all, key adjustment factors taken into account in design or analysis (ulcers judged not to be "clinically" infected and confirmed in microbiology; infection taken into account in design)
Analysis and reporting Unclear risk Moderate: data had to be extracted from graph
Overall risk of bias High risk