title: Protease-modulating polyacrylate-based hydrogel stimulates wound bed preparation in venous leg ulcers--a randomized controlled trial.
abstract: BACKGROUND
  Stringent control of proteolytic activity represents a major therapeutic approach for wound-bed preparation.
  
  
  OBJECTIVE
  We 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.
  
  
  METHODS
  Patients 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.
  
  
  RESULTS
  After 14 days of treatment there was an absolute decrease in fibrin and necrotic tissue of 37.6 ± 29.9 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).
  
  
  CONCLUSIONS
  In 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.
authors.affiliation: Research and Studies Center on the Integument (CERT), Clinical Investigation Center (CIC BT506), Department of Dermatology, University Hospital, Besançon, France; INSERM UMR, University of Franche-Comté, Besançon, France.
authors.forename: P
authors.initials: P
authors.lastname: Humbert
authors.forename: B
authors.initials: B
authors.lastname: Faivre
authors.forename: Y
authors.initials: Y
authors.lastname: Véran
authors.forename: C
authors.initials: C
authors.lastname: Debure
authors.forename: F
authors.initials: F
authors.lastname: Truchetet
authors.forename: P-A
authors.initials: PA
authors.lastname: Bécherel
authors.forename: P
authors.initials: P
authors.lastname: Plantin
authors.forename: J-C
authors.initials: JC
authors.lastname: Kerihuel
authors.forename: S A
authors.initials: SA
authors.lastname: Eming
authors.forename: J
authors.initials: J
authors.lastname: Dissemond
authors.forename: G
authors.initials: G
authors.lastname: Weyandt
authors.forename: D
authors.initials: D
authors.lastname: Kaspar
authors.forename: H
authors.initials: H
authors.lastname: Smola
authors.forename: P
authors.initials: P
authors.lastname: Zöllner
mesh_terms: D000180:Acrylic Resins / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D020100:Hydrogels; D007871:Leg Ulcer / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010447:Peptide Hydrolases / Q000008:administration & dosage*; D014647:Varicose Ulcer / Q000628:therapy*; D014947:Wounds and Injuries / Q000628:therapy*
chemical_list: D000180:Acrylic Resins; D020100:Hydrogels; C006903:carbopol 940; D010447:Peptide Hydrolases