Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
- Conditions
- Hard-to-heal Wounds
- Interventions
- Device: Antioxidant dressing (active product)Device: Usual care dressing that create a moist environment (standard clinical practice)
- Registration Number
- NCT03934671
- Lead Sponsor
- University of Jaén
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antioxidant dressing (active product) Antioxidant dressing (active product) - Usual care dressing (standard clinical practice) Usual care dressing that create a moist environment (standard clinical practice) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Time required to achieve 50% reduction in wound size Change from baseline to 8 weeks of follow up Number of completely healed wounds At baseline, after 2 week, after 4 week, after 6 week and after 8 week 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."
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
Trial Locations
- Locations (1)
Universidad de Jaén
🇪🇸Jaén, Spain