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

NCT03934671 | Completed

• 1 other identifier: TD-REOX-2019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Hard-to-heal Wounds

Keywords

Chronic wound; Wound healing; Hard-to-heal wounds; Antioxidant dressing; Oxidative stress

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Time required to achieve 50% reduction in wound size

  Change from baseline to 8 weeks of follow up

• 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

• Number of completely healed wounds

  At baseline, after 2 week, after 4 week, after 6 week and after 8 week

• Pain level

  At baseline, after 2 week, after 4 week, after 6 week and after 8 week

• Area of wound with bacterial load

  At baseline, after 2 week, after 4 week, after 6 week and after 8 week

Study Arms (2)

Antioxidant dressing (active product)

EXPERIMENTAL

Device: Antioxidant dressing (active product)

Usual care dressing (standard clinical practice)

ACTIVE COMPARATOR

Device: Usual care dressing that create a moist environment (standard clinical practice)

Interventions

Antioxidant dressing (active product) DEVICE

Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare®

Antioxidant dressing (active product)

Usual care dressing that create a moist environment (standard clinical practice) DEVICE

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

Usual care dressing (standard clinical practice)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead
• Histocell, S.L.: collaborator
• Andalusian Health Service: District Poniente Almería.: collaborator
• Andalusian Health Service: District Jaén: collaborator
• Andalusian Health Service: District Jaén-Nordeste: collaborator
• Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.: collaborator

Study Sites (1)

Universidad de Jaén

Jaén, 23071, Spain

Location

Related Publications (3)

• 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.

  PMID: 29244974 BACKGROUND

• 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.

  PMID: 26140672 BACKGROUND

• 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.

  PMID: 32513260 BACKGROUND

Related Links

• Related Info
• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 2, 2019
• Study Start: September 2, 2019
• Primary Completion: January 31, 2021
• Study Completion: October 30, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

ES (1)