May 2, 2019
April 27, 2021
The aim of this study is to compare the effect of antioxidant dressing (active product) on chronic wound healing with the use of non-active wound dressing for healing in a moist environment (standard clinical practice) in patients with hard-to-heal wounds
|Experimental: Antioxidant dressing (active product)
Device: Antioxidant dressing (active product)
Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare®
|Active Comparator: Usual care dressing (standard clinical practice)
Device: Usual care dressing that create a moist environment (standard clinical practice)
Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary
- Patients over 18 years of age.
- Patients with leg ulcers (venous, ischemic, traumatic or diabetic foot ulcer).
- Patients with dehisced surgical wounds healing by second intention.
- Patients with pressure ulcers.
- Wound area between 1 and 250 cm2.
- Systemic inflammatory disease or oncological disease.
- Wounds with clinical signs of infection.
- Terminal situation (life expectancy less than 6 months).
- Ulcers from other etiologies: tumours, infectious.
- Wounds treated with negative pressure therapy.
- History of sensitivity or allergy to any of the components of the study dressing.
In addition, criteria for withdrawal from the study will be considered:
- Worsening of the wound according to the clinical judgment of the professional
(appearance of clinical signs of infection or others).
- Appearance of allergies or hypersensitivity to the dressing.
- Hospital admission that interrupts or complicates the continuity of care in the
- Transfer to another Health District where there can be no continuity of care with the
Contact: Inés María Comino-Sanz 953213627 email@example.com
Universidad de Jaén
University of Jaén
Andalusian Health Service: District Poniente Almería.
Andalusian Health Service: District Jaén
Andalusian Health Service: District Jaén-Nordeste
Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.
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Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3.
Comino-Sanz IM, López-Franco MD, Castro B, Pancorbo-Hidalgo PL. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):505. doi: 10.1186/s13063-020-04445-5.