Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing

Study Overview
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Brief Summary
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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

Official Title
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Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing

Conditions
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Hard-to-heal Wounds

Intervention / Treatment
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* Device: Antioxidant dressing (active product)
* Device: Usual care dressing that create a moist environment (standard clinical practice)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antioxidant dressing (active product)<br> | Device: Antioxidant dressing (active product)<br>* Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare®<br>|
| Active Comparator: Usual care dressing (standard clinical practice)<br> | Device: Usual care dressing that create a moist environment (standard clinical practice)<br>* Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring | 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 | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | 
| Wound size reduction | Difference in wound area between first and last dressing | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to achieve 50% reduction in wound size |  | Change from baseline to 8 weeks of follow up | 
| 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 | 
| Number of completely healed wounds |  | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | 
| Pain level | 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. | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | 
| Area of wound with bacterial load | clinical signs of infection and/or measurement of surfaces with bacteria | At baseline, after 2 week, after 4 week, after 6 week and after 8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wound, Wound healing, Hard-to-heal wounds, Antioxidant dressing, Oxidative stress