Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing (REOX)

University of Jaén

Status

Completed

Conditions

Hard-to-heal Wounds

Treatments

Device: Antioxidant dressing (active product)

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03934671

TD-REOX-2019

Details and patient eligibility

About

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

Enrollment

54 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.