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

Hoffman 1999.

Methods Prospective cohort study/case series
Setting: community wound clinic
Country: UK
Duration of follow‐up: 36 weeks
Treatments: various dressings (NA ultra (4), wool padding (5), Zipzoc (2), Coltapaste), and compression bandages (Litepress/Co‐plus/crepe (2), Tensopress (2), Tubigrip, Elastocrepe)
Participants 7 participants with VLUs (no further details)
Age: not reported
Sex: not reported
Stage of ulcer: not reported
Ulcer duration: median (range): 3 years (13 months‐8 years) (from IPD)
Ulcer size at baseline: not reported
Wound infection: not reported
Number of wounds: 7
Inclusion criteria: VLUs
Exclusion criteria: not reported
Prognostic factors Human neutrophil elastase (continuous data); from graph IPD. All participants had data at 4 weeks, so this was selected as the baseline time; variability over time within participants. Measurement method activity assay using selective substrate and measuring change in optical density.
Elastase activity determined using a standard curve generated with pure human neutrophil elastase (Sigma, UK). Total elastase activities determined by correcting for total volume of wound fluid and phosphate‐buffered saline recovered from the bandage.
Time of measurement: baseline and weekly for 6 weeks
Wound fluid sampling method: entrapment in dressings (fluid harvested weekly from compression bandages on dressing change)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Selection bias High risk Too few participants to be representative (7 participants with VLUs at 1 centre were recruited into the study; study design changed so that measured healing after 9 months rather than 6 weeks)
Attrition bias Low risk No missing data
Prognostic factor measurement High risk Moderate: protease levels recorded from bandages when dressings changed. Protease levels will be influenced by how much remains on the dressings
Outcome measurement Unclear risk Moderate: unclear if blinded
Adjustment factors High risk None of the key adjustment factors taken into account in the design or analysis
Analysis and reporting High risk IPD given for outcome and individual protease levels given graphically. Not all participants had protease levels at baseline, but results for all for week 4; therefore, we selected this time of prognostic factor measurement
Overall risk of bias High risk