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

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ClinicalTrials.gov Identifier: NCT03934671
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Histocell
Information provided by (Responsible Party):
Inés María Comino-Sanz, 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

Condition or disease Intervention/treatment Phase
Hard-to-heal Wounds Device: Antioxidant dressing (active product) Device: Usual care dressing that create a moist environment (standard clinical practice) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antioxidant dressing (active product) Device: Antioxidant dressing (active product)

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

Device: Reoxcare®


Active Comparator: Usual care dressing (standard clinical practice) 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




Primary Outcome Measures :
  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. Time required to achieve 50% reduction in wound size [ Time Frame: Change from baseline to 8 weeks of follow up ]

Secondary Outcome Measures :
  1. 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

  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934671


Contacts
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Contact: Inés María Comino-Sanz 953213627 icomino@ujaen.es

Locations
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Spain
Universidad de Jaén Recruiting
Jaén, Spain, 23071
Contact: Inés María Comino-Sanz       icomino@ujaen.es   
Sponsors and Collaborators
University of Jaén
Histocell

Additional Information:
Publications:
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Responsible Party: Inés María Comino-Sanz, Principal Investigator, University of Jaén
ClinicalTrials.gov Identifier: NCT03934671     History of Changes
Other Study ID Numbers: TD-REOX-2019
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inés María Comino-Sanz, University of Jaén:
Chronic wound
Wound healing
Hard-to-heal wounds
Antioxidant dressing
Oxidative stress
Additional relevant MeSH terms:
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Wounds and Injuries
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs