Antioxidant dressing therapy versus standard wound care in chronic wounds (the 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 3 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 galactomannan and a hydration solution with curcumin and Nacetylcysteine. 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 the antioxidant dressing on chronic wound healing against the use of a standard wound dressing in patients with hard-to-heal wounds. Methods: We will conduct a multicentre, single-blind, 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 a control group (standard wound dressing). Assessments will be carried out at weeks 2, 4, 6 and 8. Follow-up will be for a period of 8 weeks or until complete healing if this occurs 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.

Formulation and Optimal Design of Dioscorea bulbifera and Honey-Loaded Gantrez®/Xyloglucan Hydrogel as Wound Healing Patches

“…The result of the D. bulbifera extract/honey-loaded Gan/XG correlated with a previous study showing that the ethanolic extract of D. bulbifera bulbils exhibited antioxidant activity by the DPPH radical scavenging assay [25]. The antioxidant patches are the alternative for treatment of difficult-to-heal wounds because the antioxidants help to manage wound oxidative stress and balance the level of reactive oxygen species [37][38][39].…”

The Role of Antioxidants on Wound Healing: A Review of the Current Evidence

“…For curcumin + NAC, two observational studies in patients with several type of wounds [48,50] have shown an increase in the percentage of complete healing and a reduction in wound size in patients treated with this combination of antioxidants; so this is one of the most promising therapies. Currently, a RCT is ongoing with the aim to compare the effect on the healing of chronic wounds of an antioxidant dressing with curcumin + NAC with the standard dressing treatment [73].…”

The Role of Antioxidants on Wound Healing: A Review of the Current Evidence

“…Studies investigating curcumin and N-acetyl cysteine carried out in humans, specifically observational case series studies concluded that antioxidant treatment is a suitable therapeutic alternative to achieve wound activation of non-healing wounds [44,46]. A randomized controlled trial is currently being conducted evaluating the effect of an antioxidant dressing with curcumin and N-acetyl cysteine on the healing of chronic wounds compared to standard treatment [69].…”