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

Hard-to-heal Wounds Clinical Trial

— REOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934671
• Other study ID #: TD-REOX-2019
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: December 2021
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 30, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hard-to-heal Wounds
• Wounds and Injuries

Intervention

Device:
• Antioxidant dressing (active product)
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)
Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary

Locations

Country	Name	City	State
Spain	Universidad de Jaén	Jaén

Sponsors (6)

Lead Sponsor	Collaborator
University of Jaén	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.

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Castro B, Bastida FD, Segovia T, López Casanova P, Soldevilla JJ, Verdú-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. — View 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. — View Citation

Comino-Sanz IM, López-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Primary	Wound size reduction	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	Time required to achieve 50% reduction in wound size		Change from baseline to 8 weeks of follow up
Secondary	Time to removal of non-viable tissue from wound bed		At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Secondary	Number of completely healed wounds		At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Secondary	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."	At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Secondary	Area of wound with bacterial load	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

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