title: Enzymatic debridement: is HA-collagenase the right synergy? Randomized double-blind controlled clinical trial in venous leg ulcers.
abstract: The aim of this study is to evaluate the efficacy and safety of a new ointment containing Hyaluronic Acid and collagenase from non-pathogenic Vibrio alginolyticus.
  
  
  
  Double blind, multicenter, controlled clinical trial (no. ISRCTN71239043) conducted to demonstrate the superiority of Hyaluronic Acid-Collagenase applied once a day over placebo in mean reduction of devitalized/fibrinous/slough tissue after 15 days of treatment. 113 patients with venous ulcers were enrolled and randomized to receive active treatment therapy or vehicle preparation. Both arms also received compression therapy. Subjects were assessed at baseline and at 4 different clinical study visits up to a maximum of 30 days. Outcome measures included mean percentage debridement evaluated by digital planimetry, pain during change of dressing measured on a visual analogue scale and adverse event assessment for tolerance.
  
  
  
  After 15 days the debridement rate in the active group was 67.5% compared to 59% in the placebo group (p = 0.0436). A significantly higher number of patients in the treatment group achieved 100% debridement by day 15 (p = 0.0025) than in the control group, and a higher percentage also demonstrated complete debridement at every other time point. Pain perception was similar in both groups with low levels during medication. No differences in tolerance were observed between groups.
  
  
  
  Chronic venous ulcers treated with this novel compound of Hyaluronic Acid and collagenase resulted in a significantly higher debridement rate at Day 15 vs. the control group. Hyaluronic Acid-Collagenase was well tolerated and a low degree of pain was perceived during dressing change. The preparation of 0.2% of Hyaluronic acid-collagenase shows significant benefits in the management of chronic ulcers.
authors.affiliation: Department of Clinical and Experimental Medicine, Clinic of Plastic and Reconstructive Surgery, Ancona United Hospitals, Marche Polytechnic University, Ancona, Italy. chiplast@univpm.it.
authors.forename: A
authors.initials: A
authors.lastname: Scalise
authors.forename: F
authors.initials: F
authors.lastname: Campitiello
authors.forename: A
authors.initials: A
authors.lastname: Della Corte
authors.forename: P
authors.initials: P
authors.lastname: Longobardi
authors.forename: M
authors.initials: M
authors.lastname: Di Salvo
authors.forename: C
authors.initials: C
authors.lastname: Tartaglione
authors.forename: C
authors.initials: C
authors.lastname: Santin
authors.forename: N
authors.initials: N
authors.lastname: Giordan
authors.forename: G
authors.initials: G
authors.lastname: Guarnera
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017364:Collagenases / Q000627:therapeutic use*; D003646:Debridement; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy*; D014945:Wound Healing
chemical_list: D017364:Collagenases