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

December 20, 2021 updated by: Inés María Comino-Sanz, University of Jaen
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Jaén, Spain, 23071
        • Universidad de Jaén

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
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
At baseline, after 2 week, after 4 week, after 6 week and after 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to achieve 50% reduction in wound size
Time Frame: Change from baseline to 8 weeks of follow up
Change from baseline to 8 weeks of follow up
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
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Number of completely healed wounds
Time Frame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
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."
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
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
At baseline, after 2 week, after 4 week, after 6 week and after 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jaen

Collaborators

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD-REOX-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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