| Summary: | Diabetic patients frequently develop wounds, which can be colonized by bacteria, mainly <i>Staphylococcus aureus</i> and <i>Pseudomonas aeruginosa</i>, with the ability to form biofilms. This study aimed to evaluate the colonization and biofilm formation of <i>Staphylococcus aureus</i> and <i>Pseudomonas aeruginosa</i> in chronic wounds of diabetic patients treated with a bioactive dressing (EGF-CMC), which consisted of a 2% carboxymethylcellulose (CMC) hydrogel loaded with epidermal growth factor (EGF). This randomized clinical trial was conducted with 25 participants: 14 treated with EGF-CMC hydrogel and 11 treated with CMC hydrogel for 12 weeks. Participants with type 2 diabetes mellitus were selected. All had diabetic foot ulcers or chronic venous ulcers. Swab collections were performed on weeks 1, 6, and 12. The laboratory analyses included the identification of strains, microbial quantification, virulence gene investigation, and the evaluation of biofilm formation. In total, 13 <i>S. aureus</i> strains and 15 <i>P. aeruginosa</i> strains were isolated. There were no statistically significant differences regarding bacterial loads and virulence genes. However, EGF-CMC-hydrogel-treated wounds were colonized by strains with lower biofilm formation abilities. The probability of isolating biofilm-producing strains from CMC-hydrogel-treated wounds was 83% greater than the probability of isolating biofilm-producing strains from EGF-CMC-treated wounds.
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