Bacterial biocellulosis for the treatment of clean arterial wounds: clinical study phase II

• Grant number: 20/07761-0
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: January 01, 2021
• End date: December 31, 2021
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Matheus Bertanha
• Grantee: Arthur Mestriner Bassanelli
• Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Peripheral arterial disease (PAD) is a manifestation of atherosclerotic disease that affects peripheral arterial blood flow, especially in the lower limbs, with an estimated frequency in international studies of 10% to 12% in the adult population and 20% of the population above 75 years old, predominantly male. The best treatment for the disease is considered to be the arterial revascularization of the affected limb, however, even with the best revascularization techniques, many patients still have ulcers that are difficult to heal, which may require secondary care with dressings for long periods. periods with high personal cost and the health system. All efforts to increase the quality of life and improve the chances of wound healing are valid, so that the development of new products for use in dressings can be an additional tool for the control of this disease. Objectives: To evaluate the use of bacterial cellulose gel as an adjunct in the healing process of ulcers in patients with PAD. Methods: Through this clinical study, it is intended to include 15 participants with PAD andclean ulcers. Patients will be followed up in a single group for 60 days, receiving instructions to perform the dressings with bacterial cellulose hydrogel on an outpatient basis and periodic clinical evaluations will be carried out, in addition to the photographic record. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be related to death, infections, gangrene and amputations. The results will be evaluated by an external evaluator.