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

NCT03934671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-12-21

No results posted yet for this study

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

Interventions

DEVICE

Antioxidant dressing (active product)

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

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

Sponsors & Collaborators

  • Histocell, S.L.

    collaborator INDUSTRY

  • Andalusian Health Service: District Poniente Almería.

    collaborator UNKNOWN

  • Andalusian Health Service: District Jaén

    collaborator UNKNOWN

  • Andalusian Health Service: District Jaén-Nordeste

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • University of Jaén

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2021-01-31
Completion
2021-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03934671 on ClinicalTrials.gov