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

University of Jaén54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hard-to-heal Wounds

Interventions

Antioxidant dressing (active product)DEVICE

Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare®

Usual care dressing that create a moist environment (standard clinical practice)DEVICE

Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universidad de Jaén

Jaén, Spain

Outcomes

Primary Outcomes

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