Clinical trial NCT03934671: Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
Official title: Evaluation of the Efficacy of an Antioxidant Dressing in Chronic Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hard-to-heal Wounds
Keywords: Chronic wound
Wound healing
Hard-to-heal wounds
Antioxidant dressing
Oxidative stress
Lead sponsor: University of Jaén
Sponsor class: OTHER
Collaborators: name: Histocell, S.L.
name: Andalusian Health Service: District Poniente Almería.
name: Andalusian Health Service: District Jaén
name: Andalusian Health Service: District Jaén-Nordeste
name: Andalusian Health Service: Health Management Area Este of Málaga-Axarquía.
First posted: 2019-05-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in the score of the RESVECH 2.0 scale for chronic wound healing monitoring
timeFrame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
measure: Wound size reduction
timeFrame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Secondary outcomes:
measure: Time required to achieve 50% reduction in wound size
timeFrame: Change from baseline to 8 weeks of follow up
measure: Time to removal of non-viable tissue from wound bed
timeFrame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
measure: Number of completely healed wounds
timeFrame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
measure: Pain level
timeFrame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
measure: Area of wound with bacterial load
timeFrame: At baseline, after 2 week, after 4 week, after 6 week and after 8 week
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: Universidad de Jaén
Study officials:
References:
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.
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.
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.