ABSTRACT
Title
Performance and tolerability of a medical device containing hyaluronic acid and collagenase for the management of chronic venous ulcers
Authors
S.R. Georgescu1, V. Clatici2, S.H. Morariu3, I. Stoicescu4, N. Giordan5, F. Montanaro6, D.F. Barattini6
1 Spitalul Clinic Dermato-Venerice "Prof. Dott. Scarlat Ionghin", Bucuresti, Romania
2 Spitalul Universitar Elias, Bucuresti, Romania
3 Spitalul Clinic Municipal, Targu Mures, Romania
4 Clinica de Dermatologie, Spitalul Clinic Judetean Craiova, Craiova, Romania
5Fidia Farmaceutici S.p.A., Abano Terme (PD), Italy
6Opera Srl, Genova, Italy
1 Spitalul Clinic Dermato-Venerice "Prof. Dott. Scarlat Ionghin", Bucuresti, Romania
2 Spitalul Universitar Elias, Bucuresti, Romania
3 Spitalul Clinic Municipal, Targu Mures, Romania
4 Clinica de Dermatologie, Spitalul Clinic Judetean Craiova, Craiova, Romania
5Fidia Farmaceutici S.p.A., Abano Terme (PD), Italy
6Opera Srl, Genova, Italy
Abstract
Venous ulcers are extremely common affecting approximately 1% of the world’s population. Due to their chronicity and relatively high prevalence, their impact on cost of healthcare and the lives of the subjects is quite significant (Reichenberg and Davis, 2005). Independently of their origin, all ulcers heal through a complex mechanism involving a number of common events: regression of necrotic parts, formation of granulation tissue and, finally, re-epithelialization. Wound bed preparation is an important key step towards effective wound healing by removing barriers to the wound repair process. It is well-known that a moist, not dry, environment is most conducive to healing. The importance of a moist environment in wound healing is well established and it will also support painless debridement by autolysis. In addition, the number of macrophages present is significantly greater in a moist wound environment than in a dry environment (Chang et al., 1996). In chronic wounds the concept of maintenance debridement is an interesting one since the initial debridement phase may need to be followed by a maintenance phase to keep the ongoing necrotic tissue from accumulating. A logical approach to develop more effective dressing for wound debridement phase in the management of chronic wounds is to identify effective agents that have a selective effect for the necrotic tissue and at the same time protective properties on living tissue (new granulation tissue).
The present study was aimed to evaluate the performance and tolerability of LHAC1- BIONECT START, a new medical device for topical application, in the wound bed preparation phase in the treatment of necrotic tissue debridement of chronic venous ulcers. This product is a topical preparation (ointment) containing hyaluronic acid sodium salt (HA), obtained from bacterial fermentation that provide an optimal moisture balance, and bacterial collagenase, obtained from non pathogenic Vibrio alginolyticus, that removes necrotic tissue.
A total of 100 subjects were enrolled in the study.No subject withdrew from the study. After baseline(Day 0), a maximum number of 4 visits were planned: Visit 1(Day 5), Visit 2(Day 10), Visit 3(Day 15), Visit4 (Day 20). The visit where the debridement was ascertained was considered the final visit. The percentage of subjects who reached the complete ulcer debridement was estimated and time to healing was analyzed using Kaplan-Meier method. The necrotic area was measured by tracing the necrotic area of the wound bed on the grid and reduction between baseline and final visit was assessed using repeated measures t-test. The status of the wound bed and periwound skin was evaluated by descriptive judgement estimating, odour, moisture balance and viability of non-necrotic area and the presence of erythema/redness in periwound skin. Differences between final visit and baseline was analyzed using Wilcoxon Signed Rank Test.
All 100 subjects achieved complete debridement within 22 days and the median time to debridement was estimated to be 11 days. The average lesion area was considerably reduced and the lesion completely disappeared in two subjects. The mean reduction in lesion area from baseline to final visit was 4.40 cm2 (p<0.0001).A clear trend towards improvement of all indicators (odour, moisture balance and viability of non-necrotic area and the presence of erythema/redness in periwound skin)was observed. The safety of the device appeared globally satisfactory. No sensitivity reactions have been reported by patients.
Concluding, the device LHAC1- BIONECT STARTdemonstrated to be efficient and safe in the debridement of the ulcers.
Chang H, Wind S, Kerstein MD. Moist wound healing. Dermatol Nurs 1996;8:174-6.
Reichenberg J, Davis M. Venous ulcers. Semin Cutan Med Surg 2005; 24:216-26
The present study was aimed to evaluate the performance and tolerability of LHAC1- BIONECT START, a new medical device for topical application, in the wound bed preparation phase in the treatment of necrotic tissue debridement of chronic venous ulcers. This product is a topical preparation (ointment) containing hyaluronic acid sodium salt (HA), obtained from bacterial fermentation that provide an optimal moisture balance, and bacterial collagenase, obtained from non pathogenic Vibrio alginolyticus, that removes necrotic tissue.
A total of 100 subjects were enrolled in the study.No subject withdrew from the study. After baseline(Day 0), a maximum number of 4 visits were planned: Visit 1(Day 5), Visit 2(Day 10), Visit 3(Day 15), Visit4 (Day 20). The visit where the debridement was ascertained was considered the final visit. The percentage of subjects who reached the complete ulcer debridement was estimated and time to healing was analyzed using Kaplan-Meier method. The necrotic area was measured by tracing the necrotic area of the wound bed on the grid and reduction between baseline and final visit was assessed using repeated measures t-test. The status of the wound bed and periwound skin was evaluated by descriptive judgement estimating, odour, moisture balance and viability of non-necrotic area and the presence of erythema/redness in periwound skin. Differences between final visit and baseline was analyzed using Wilcoxon Signed Rank Test.
All 100 subjects achieved complete debridement within 22 days and the median time to debridement was estimated to be 11 days. The average lesion area was considerably reduced and the lesion completely disappeared in two subjects. The mean reduction in lesion area from baseline to final visit was 4.40 cm2 (p<0.0001).A clear trend towards improvement of all indicators (odour, moisture balance and viability of non-necrotic area and the presence of erythema/redness in periwound skin)was observed. The safety of the device appeared globally satisfactory. No sensitivity reactions have been reported by patients.
Concluding, the device LHAC1- BIONECT STARTdemonstrated to be efficient and safe in the debridement of the ulcers.
Chang H, Wind S, Kerstein MD. Moist wound healing. Dermatol Nurs 1996;8:174-6.
Reichenberg J, Davis M. Venous ulcers. Semin Cutan Med Surg 2005; 24:216-26