DOI: https://doi.org/10.21203/rs.3.rs-16762/v1
Background: A wound that does not heal in the orderly stages of the healing process or does not heal within three months is considered a chronic wound. Wound healing is impaired when the wound remains in the inflammatory stage for too long. A range of factors can delay the healing process: imbalance between proteases and protease inhibitors in the wound bed; bacterial colonization and the presence of biofilm; and oxidative stress.
Recently, wound management has improved significantly. A new antioxidant dressing has been developed, which combines an absorbent matrix obtained from Locust Bean Gum (LBG) galactomannan and a hydration solution with curcumin and N-acetylcysteine (NAC). This dressing combines the advantages of moist healing in exudate management and free radical neutralization, achieving wound reactivation.
The primary aim of this study is to compare the effect of antioxidant dressing on chronic wound healing with the use of standard wound dressing in patients with hard-to-heal wounds.
Methods: We will conduct a multicentre, open, randomized, controlled trial with parallel groups. Participants will be selected from three primary public health-care centres, located in Andalucía (southern Spain). Patients will be randomized into an intervention group (antioxidant dressing) or control group (standard wound dressing). Assessment will be carried out in weeks 2, 4, 6 and 8. The follow-up of patients will be prolonged until week 8 or complete healing.
Discussion: The findings from this study should provide scientific evidence on the efficacy of 20 the antioxidant dressing as an alternative for the treatment of chronic wounds. This study fills 21 some of the gaps in the existing knowledge about patients with hard-to-heal wounds.
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