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 |