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HYDROFIBER with silver versus colagenase for treatment of critical colonization in venous ulcers: randomized clinical trial

Grant number: 20/01768-3
Support Opportunities:Regular Research Grants
Duration: June 01, 2020 - May 31, 2022
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Luciana Patrícia Fernandes Abbade
Grantee:Luciana Patrícia Fernandes Abbade
Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
Associated researchers:Vera Lúcia Mores Rall


Venous ulcers (VU) are the most common cause of leg ulcers causing socioeconomic impact and worsening quality of life. Its prognosis is generally poor due to long healing and recurrent ulcers. Like VU, all chronic ulcers are colonized by various bacteria. Some of these microorganisms have the ability to group together in the middle of the extracellular matrix on the surface of the tissue in which they are found, forming the biofilm. Biofilm can hamper healing, and predispose to superficial and deep infection. Objectives: To evaluate the action of the silver hydrofiber dressing on the control of critical colonization (superficial infection) and biofilm formation by inhibiting bacterial growth compared to the dressing with collagenase, both after superficial surgical debridement in patients with VU who used these interventions for 30 days. Method: Randomized-controlled clinical trial, parallel, open, with two-arm. It will be performed at the chronic ulcers outpatient clinic of the Hospital das Clínicas of the Botucatu Medical School (FMB / UNESP) with patients with chronic VU. The ulcers will be measured, cleaning with 0.9% saline. Soon afterwards, material will be collected using a swab for microbiological analysis. All ulcers will receive superficial surgical debridement. After the participants will be randomized into two parallel treatment groups - silver hydrofiber group and the Collagenase group. Both groups will receive compression therapy. Outcomes will be assessed after 30 days of interventions. The primary ones will be: rate of ulcers without signs of superficial infection; rate of ulcers with decreased bacterial load, rate of ulcers with biofilm-producing bacteria, rate of ulcers with change in bacterial identity, assessed at T30 by microbiology methods. Secondary outcomes will be: clinical improvement of VU; reduction of the ulcer area using the planimetric method and healing rate clinically assessed at T30 by observing total epithelialization without the presence of crusts at the VU site. The statistical analysis will be by intention to treat and the data will be analyzed using the SPSS 20.0 software. P <0.05 will be considered significant. (AU)

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