Antioxidant dressing therapy versus standard wound care in chronic wounds (REOX study): Study protocol for a randomized controlled trial

Abstract

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, single blinded, 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. Follow-up will be of 8 weeks or complete healing, if it happens earlier.Discussion: The findings from this study should provide scientific evidence on the efficacy of the antioxidant dressing as an alternative for the treatment of chronic wounds. This study fills some of the gaps in the existing knowledge about patients with hard-to-heal wounds.Trial registration: ClinicalTrials.gov, NCT03934671. Registered on 2 May 2019.

Assessment of chemically and enzymatically modified chitosan with eugenol as a coating for viscose functionalization for potential medical use

“…In addition, the antioxidant activity of natural antioxidants, including eugenol, has been shown to play a critical role in tissue repair under normal and pathological conditions with antibacterial and anti-inflammatory effects, by scavenging the reactive oxygen species (ROS) resulting from oxidative damage, thereby improving wound healing and other tissue infections. 50,55 In addition, some recently published data suggest a positive cost-benefit balance for the treatment of venous ulcers with eugenol-based antioxidant dressings. 53,56 It must be pointed out that the functionalization process is technologically and economically suitable to be transferred into real-life conditions, while some process design and cost aspects must be studied for real applications.…”