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

Primary Purpose

Hard-to-heal Wounds

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Antioxidant dressing (active product)
Usual care dressing that create a moist environment (standard clinical practice)
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hard-to-heal Wounds focused on measuring Chronic wound, Wound healing, Hard-to-heal wounds, Antioxidant dressing, Oxidative stress

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de Jaén

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antioxidant dressing (active product)

Usual care dressing (standard clinical practice)

Arm Description

Outcomes

Primary Outcome Measures

Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
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
Wound size reduction
Difference in wound area between first and last dressing

Secondary Outcome Measures

Time required to achieve 50% reduction in wound size
Time to removal of non-viable tissue from wound bed
Number of completely healed wounds
Pain level
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."
Area of wound with bacterial load
clinical signs of infection and/or measurement of surfaces with bacteria

Full Information

First Posted
April 24, 2019
Last Updated
December 20, 2021
Sponsor
University of Jaén
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.
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1. Study Identification

Unique Protocol Identification Number
NCT03934671
Brief Title
Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
Acronym
REOX
Official Title
Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
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.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hard-to-heal Wounds
Keywords
Chronic wound, Wound healing, Hard-to-heal wounds, Antioxidant dressing, Oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antioxidant dressing (active product)
Arm Type
Experimental
Arm Title
Usual care dressing (standard clinical practice)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Antioxidant dressing (active product)
Intervention Description
Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare®
Intervention Type
Device
Intervention Name(s)
Usual care dressing that create a moist environment (standard clinical practice)
Intervention Description
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 Measure Information:
Title
Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
Description
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
Time Frame
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Title
Wound size reduction
Description
Difference in wound area between first and last dressing
Time Frame
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Secondary Outcome Measure Information:
Title
Time required to achieve 50% reduction in wound size
Time Frame
Change from baseline to 8 weeks of follow up
Title
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
Title
Number of completely healed wounds
Time Frame
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Title
Pain level
Description
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."
Time Frame
At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Title
Area of wound with bacterial load
Description
clinical signs of infection and/or measurement of surfaces with bacteria
Time Frame
At baseline, after 2 week, after 4 week, after 6 week and after 8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Universidad de Jaén
City
Jaén
ZIP/Postal Code
23071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29244974
Citation
Castro B, Bastida FD, Segovia T, Lopez Casanova P, Soldevilla JJ, Verdu-Soriano J. The use of an antioxidant dressing on hard-to-heal wounds: a multicentre, prospective case series. J Wound Care. 2017 Dec 2;26(12):742-750. doi: 10.12968/jowc.2017.26.12.742.
Results Reference
background
PubMed Identifier
26140672
Citation
Castro B, Palomares T, Azcoitia I, Bastida F, del Olmo M, Soldevilla JJ, Alonso-Varona A. Development and preclinical evaluation of a new galactomannan-based dressing with antioxidant properties for wound healing. Histol Histopathol. 2015 Dec;30(12):1499-512. doi: 10.14670/HH-11-646. Epub 2015 Jul 3.
Results Reference
background
PubMed Identifier
32513260
Citation
Comino-Sanz IM, Lopez-Franco MD, Castro B, Pancorbo-Hidalgo PL. Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial. Trials. 2020 Jun 8;21(1):505. doi: 10.1186/s13063-020-04445-5.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29244974
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/26140672
Description
Related Info

Learn more about this trial

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

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