Protease-modulating polyacrylate-based hydrogel stimulates wound bed preparation in venous leg ulcers - a randomized controlled trial

BackgroundStringent control of proteolytic activity represents a major therapeutic approach for wound-bed preparation. ObjectivesWe tested whether a protease-modulating polyacrylate- (PA-) containing hydrogel resulted in a more efficient wound-bed preparation of venous leg ulcers when compared to an amorphous hydrogel without known protease-modulating properties. MethodsPatients were randomized to the polyacrylate-based hydrogel (n=34) or to an amorphous hydrogel (n=41). Wound beds were evaluated by three blinded experts using photographs taken on days 0, 7 and 14. ResultsAfter 14 days of treatment there was an absolute decrease in fibrin and necrotic tissue of 37.629.9 percentage points in the PA-based hydrogel group and by 16.8 +/- 23.0 percentage points in the amorphous hydrogel group. The absolute increase in the proportion of ulcer area covered by granulation tissue was 36.0 +/- 27.4 percentage points in the PA-based hydrogel group and 14.5 +/- 22.0 percentage points in the control group. The differences between the groups were significant (decrease in fibrin and necrotic tissue P=0.004 and increase in granulation tissue P=0.0005, respectively). ConclusionIn particular, long-standing wounds profited from the treatment with the PA-based hydrogel. These data suggest that PA-based hydrogel dressings can stimulate normalization of the wound environment, particularly in hard-to-heal ulcers.