OBJECTIVE: To confirm the safety and wound healing activity of a topical spray powder containing hyaluronic acid (HA) and metallic silver (Hyalosilver, Fidia Farmaceutici S.p.A., Italy), and investigate its effect on the control of bacterial load in vascular ulcers or category I-II pressure ulcers (PU). METHODS: This is a single site, prospective, open label study involving patients with a vascular ulcer or category I-II PUs, presenting signs of critical bacterial colonisation. Patients with a wound size of ≤15cm2 were enrolled. At baseline, a swab was taken of each wound for a semi-quantitative analysis of bacterial load and the first treatment of topical spray powder was applied. The patient was then requested to self-apply the medication once a day for 28 consecutive days and to return on days one, seven and 28 for clinical and microbiological assessments. RESULTS: A total of 25 patients were enrolled in the study. Treatment with the topical spray powder enhanced the healing rate of chronic wounds in terms of a reduction of wound area as well as bacterial load (p<0.025) and the overall clinical status of wound (odour, exudate, erythema of periwound skin; p<0.017). Moreover, the spray powder increased overall patient perception of improvement in the wound (p<0.05). CONCLUSION: The data demonstrated good safety and tolerability of the topical spray powder suggesting that the product is effective not only in reducing wound area, due to the presence of HA, but in keeping the bacterial colonisation under control.
OBJECTIVE: To confirm the safety and wound healing activity of a topical spray powder containing hyaluronic acid (HA) and metallic silver (Hyalosilver, Fidia Farmaceutici S.p.A., Italy), and investigate its effect on the control of bacterial load in vascular ulcers or category I-II pressure ulcers (PU). METHODS: This is a single site, prospective, open label study involving patients with a vascular ulcer or category I-II PUs, presenting signs of critical bacterial colonisation. Patients with a wound size of ≤15cm2 were enrolled. At baseline, a swab was taken of each wound for a semi-quantitative analysis of bacterial load and the first treatment of topical spray powder was applied. The patient was then requested to self-apply the medication once a day for 28 consecutive days and to return on days one, seven and 28 for clinical and microbiological assessments. RESULTS: A total of 25 patients were enrolled in the study. Treatment with the topical spray powder enhanced the healing rate of chronic wounds in terms of a reduction of wound area as well as bacterial load (p<0.025) and the overall clinical status of wound (odour, exudate, erythema of periwound skin; p<0.017). Moreover, the spray powder increased overall patient perception of improvement in the wound (p<0.05). CONCLUSION: The data demonstrated good safety and tolerability of the topical spray powder suggesting that the product is effective not only in reducing wound area, due to the presence of HA, but in keeping the bacterial colonisation under control.
Authors: Diogo Marcelo Lima Ribeiro; Alexsander Rodrigues Carvalho Júnior; Gustavo Henrique Rodrigues Vale de Macedo; Vitor Lopes Chagas; Lucas Dos Santos Silva; Brenda da Silva Cutrim; Deivid Martins Santos; Bruno Luis Lima Soares; Adrielle Zagmignan; Rita de Cássia Mendonça de Miranda; Priscilla Barbosa Sales de Albuquerque; Luís Cláudio Nascimento da Silva Journal: Biomolecules Date: 2019-12-30