Hard-to-heal Wounds
Conditions
Keywords
Chronic wound, Wound healing, Hard-to-heal wounds, Antioxidant dressing, Oxidative stress
Brief summary
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
Interventions
DEVICEAntioxidant dressing (active product)
Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare®
DEVICEUsual 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
Sponsors
Histocell, S.L.
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.
University of Jaén
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Pregnancy. * 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. * Death. * Hospital admission that interrupts or complicates the continuity of care in the Nursing Consultation. * Transfer to another Health District where there can be no continuity of care with the active dressing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | The RESVECH 2.0 is a scale for monitoring the cicatrization of the wound. It has 6 items: size of the lesion, depth/tissue concerned, edges, type of tissue in the wound bed, exudate, infection/inflammation. The scale is scored numerically and can score ranging from 0 to 35 points, wound healed and the worst possible lesion respectively |
| Wound size reduction | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | Difference in wound area between first and last dressing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of completely healed wounds | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | — |
| Time required to achieve 50% reduction in wound size | Change from baseline to 8 weeks of follow up | — |
| Area of wound with bacterial load | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | clinical signs of infection and/or measurement of surfaces with bacteria |
| Pain level | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | The visual analogue scale (VAS) is commonly used as the outcome measure for patient´s pain. It is usually presented as a 100-mm horizontal line on which pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. |
| Time to removal of non-viable tissue from wound bed | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | — |
Countries
Spain
Outcome results
None listed