Skip to main content
OpenTrials
Completed

NCT Number: NCT03934671

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hard-to-heal Wounds

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Jaén

Jaén, 23071, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring

    Time frame: 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

  2. Wound size reduction

    Time frame: 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 outcomes

  1. Time required to achieve 50% reduction in wound size

    Time frame: Change from baseline to 8 weeks of follow up

  2. Time to removal of non-viable tissue from wound bed

    Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week

  3. Number of completely healed wounds

    Time frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week

  4. Pain level

    Time frame: 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."

  5. Area of wound with bacterial load

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Collaborators

  • Andalusian Health Service: District Jaén
  • Andalusian Health Service: District Jaén-Nordeste
  • Andalusian Health Service: District Poniente Almería.
  • Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.
  • Histocell, S.L.

Registry information

Acronym: REOX

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 2, 2019
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.