An evaluation of Hyalofill-F plus compression bandaging in the treatment of chronic venous ulcers.

OBJECTIVE: Hyaluronan, a component of the extracellular matrix, plays a significant role in several aspects of tissue repair and the wound healing process. METHOD: In this Italian study Hyalofill-F, a partial benzyl ester derivative of hyaluronan, used in combination with compression bandaging, was compared with the well-established therapy in Italy of non-adherent gauze plus compression therapy in the treatment of chronic venous leg ulcers. RESULTS: Hyalofill-F plus compression bandaging performed significantly better than non-adherent gauze plus compression bandage in all of the clinically relevant efficacy parameters. Mean reduction in ulcer area in the hyaluronan-derivative group was 8.1 cm2 after eight weeks of treatment, compared with 0.4 cm2 in the comparator group. The resulting difference of 7.7 cm2 between the two groups was statistically significant (p = 0.0019). Furthermore, statistically significant results in favour of the hyaluronan-derivative group were obtained in the following: speed of epithelialisation; leveling of the margins; degree of maceration; pain intensity and frequency. CONCLUSION: Hyalofill-F plus compression bandaging resulted in an earlier and greater decrease in ulcer area compared with non-adherent gauze plus compression bandaging, therapy supporting its use in the treatment of chronic venous ulcers.

A trial to assess the efficacy and tolerability of Hyalofill-F in non-healing venous leg ulcers.

OBJECTIVE: This single-centre, open, uncontrolled pilot clinical trial set out to assess the efficacy and tolerability of Hyalofill-F (a partial benzyl ester derivative of hyaluronan), used in combination with compression bandaging, in the treatment of venous leg ulcers. METHOD: The 20 patients enrolled into the study had venous insufficiency and a leg ulcer that had been refractory to treatment for one month. Treatment was continued for eight weeks, with weekly assessments. RESULTS: During the study period four of the patients' ulcers healed completely. An average wound area reduction of 53.5% was seen in the ulcers that did not heal. Differences in ulcer area and ulcer depth between the initial and final visit were significant (p < 0.01, p = 0.03). The average healing rate (cm2/week reduction) was 1.26 +/- 1.7 (standard deviation). A calculated prognostic index was used to identify patients at high risk of a poor response to compression therapy (10% probability of wound closure at 120 weeks). These patients demonstrated a mean 63% decrease in wound area after eight weeks of treatment with Hyalofill-F plus compression bandaging. All wounds showed a positive response in terms of granulation-tissue formation. The comfort of the dressing was described as excellent. CONCLUSION: The hyaluronan derivative showed promising results in initiating the healing process in chronic venous ulcers. It was found to be well tolerated and safe to use. However, further clinical trials should be performed involving a control group to verify these data. DECLARATION OF INTEREST: This study was sponsored by Fidia Advanced Biopolymers, Italy.