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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2021-10-30

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

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Detailed Description

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Conditions

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Hard-to-heal Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Antioxidant dressing (active product)

Group Type EXPERIMENTAL

Antioxidant dressing (active product)

Intervention Type DEVICE

Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary.

Device: Reoxcare®

Usual care dressing (standard clinical practice)

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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Antioxidant dressing (active product)

Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary.

Device: Reoxcare®

Intervention Type DEVICE

Usual 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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No