The Ravenna Hyperbaric Centre is once again at the forefront in the field of research, in this case on wound care treatment. Indeed, a study entitled “Enzymatic debridement: is HA-collagenase the right synergy? The Randomized double-blind controlled clinical trial in venous leg ulcers” has been recently published on the magazine “European Review for Medical and Pharmacological Sciences”, which saw the participation of some of our patients and signed by the main experts of the sector among which our Medical Director Dr Pasquale Longobardi.
The organization of our Centre is followed by Dr Nedjoua Belkacem, by the Wound Care Nursing Staff coordinated by the Nurse Klarida Hoxha and by our Responsible for Human Resources, Andrea Rambelli.
The study’s aim is to evaluate the efficacy and the security of a new unguent containing hyaluronic acid and collagenase deriving from a no pathogenic bacterium called “Vibrio alginolyticus”.
It consists of a multicentric, controlled double-blind test to show the superiority of this hyaluronic acid-collagen applied once a day with respect to placebo, which showed an average reduction of the necrotic tissue with abundant fibrin that detached 15 days after the treatment.
113 patients with venous ulcers have been taken charge and randomized to receive an active therapy or the placebo drug. Both groups received a compression therapy.
The patients were evaluated at the beginning and in four subsequent visits of study, up to a maximum of 30 days. The effectiveness evaluation is based on:
- The debridement average percentage (that is the necrotic tissue reduction and with abundant fibrin) evaluated by mapping
- Pain during the change of medication, measured through a pain visual scale
- Evaluation of the potential adverse/side effects
The results were of great level: after 15 days the debridement rate in the active group was of 67.5% with respect to 59% in the placebo group (p=0.0436).
A significantly greater number of patients in the treatment group reached the 100% debridement on day 15 (p=0.0025) compared with the control group and an even higher percentage showed a complete debridement in every other moment of control. Pain perception was similar in both groups, in particular, it was low during the entire period of prescription and no discrepancy was registered among the groups.
The study allowed to conclude that the treatment with this new hyaluronic acid compound and collagenase on the chronic venous ulcers determined a debridement rate significantly higher on day 15 compared to the rest of the group. Hyaluronic acid and collagenase were well tolerated and a low pain rate was perceived during the dressing removal. 0.2% of hyaluronic acid-collagenase shows great improvements in chronic ulcers management.