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

  • Clinicaltrials.gov identifier

    NCT03934671

  • Recruitment Status

    Recruiting

  • First Posted

    May 2, 2019

  • Last update posted

    April 27, 2021

Study Description

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:Hard-to-heal Wounds
  • Intervention/Treatment: Device: Antioxidant dressing (active product)
    Device: Usual care dressing that create a moist environment (standard clinical practice)
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: January 2021
  • Actual Study Completion Date: September 2021

Arms and interventions

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

Outcome Measures

  • Primary 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. 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
  • Secondary Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: 18 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.

Contacts and Locations

Contacts

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

Locations

Spain
Universidad de Jaén
Jaén

Sponsors and Collaborators

University of Jaén

Histocell, S.L.

Andalusian Health Service: District Poniente Almería.

Andalusian Health Service: District Jaén

Andalusian Health Service: District Jaén-Nordeste

Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.

More Information