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| Name | Class |
|---|---|
| Histocell, S.L. | INDUSTRY |
| Andalusian Health Service: District Poniente Almería. | UNKNOWN |
| Andalusian Health Service: District Jaén | UNKNOWN |
| Andalusian Health Service: District Jaén-Nordeste |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antioxidant dressing (active product) | Experimental |
| |
| Usual care dressing (standard clinical practice) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antioxidant dressing (active product) | Device | Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary. Device: Reoxcare® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
In addition, criteria for withdrawal from the study will be considered:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Jaén | Jaén | 23071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29244974 | Background | 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. | |
| 26140672 | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| UNKNOWN |
| Andalusian Health Service: Health Management Area Este of Málaga-Axarquía. | UNKNOWN |
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| 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 |
|
| Number of completely healed wounds | At baseline, after 2 week, after 4 week, after 6 week and after 8 week |
| 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 |
| 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 |
| 32513260 | 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. |
| Related Info | View source |