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Modified negative pressure therapy in the management of decubitus and lower limb ulcers

Grant number: 21/10760-9
Support Opportunities:Regular Research Grants
Duration: March 01, 2022 - February 29, 2024
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:Daniel Guimarães Cacione
Grantee:Daniel Guimarães Cacione
Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil
Associated researchers: francisco cialdine frota carneiro junior ; José Carlos Costa Baptista-Silva ; Marcus Vinicius Canteras Raposo da Camara ; Plínio Marcos Basílio Garcia


Decubitus and lower limb ulcers are frequent and complex conditions that cause suffering to the patient, prolonged hospitalization and high costs to the public health system. The current context of the COVID-19 pandemic is known to have increased the incidence of pressure ulcers, further aggravating the situation. Negative pressure-assisted ulcer healing acceleration therapy is an effective treatment modality for complex wounds, but it is costly. Reducing the costs of this therapy, using accessible materials, is the current challenge in this issue. Thus, to assess the effectiveness of the modified vacuum dressing concerning the usual dressing in patients hospitalized with decubitus and non-ischemic lower limb ulcers, we propose a randomized crossover pilot clinical trial (phase 2 study) with 20 patients, comparing modified negative pressure therapy ("modified vacuum dressing"), that is, using low-cost materials and without controlling the pressure exerted on the dressing versus the usual dressing (without using negative pressure) in this group of patients. Study outcomes to be evaluated are wound improvement, rate of complete wound healing, readmission rate, reoperation rate, intervention complications, and cost of treatment. The treatment time per patient will be 30 days, with a total study time estimated at 12 months. The negative pressure dressing is expected to accelerate wound healing, helping patients and decreasing the total cost of treatment, resulting in an impact on the assistance to these patients and a significant reduction in treatment costs for the Unified Health System. (AU)

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