Publication:
Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).

dc.contributor.authorMorilla-Herrera, Juan C
dc.contributor.authorMorales-Asencio, José M
dc.contributor.authorGómez-González, Alberto J
dc.contributor.authorDíez-De Los Ríos, Antonio
dc.contributor.authorLupiáñez-Pérez, Inmaculada
dc.contributor.authorAcosta-Andrade, Carlos
dc.contributor.authorAranda-Gallardo, Marta
dc.contributor.authorMoya-Suárez, Ana B
dc.contributor.authorKaknani-Uttumchandani, Shakira
dc.contributor.authorGarcía-Mayor, Silvia
dc.contributor.funderInstitute for Biomedical Research of Málaga (IBIMA)
dc.contributor.funderBSN Medical for the provision of products and materials
dc.contributor.funderRegional Ministry of Health of Andalucía
dc.contributor.funderInstituto de Salud Carlos III
dc.date.accessioned2023-02-08T14:50:03Z
dc.date.available2023-02-08T14:50:03Z
dc.date.issued2020-06-08
dc.description.abstractTo determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact® ) against a silver dressing (Aquacel® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing. Open randomized controlled trial, with blinded endpoint. Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks. Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced. Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.
dc.description.sponsorshipThis study is sponsored by the Institute for Biomedical Research of Málaga (IBIMA) and funded by BSN Medical for the provision of products and materials. IBIMA is a Public Research Institute belonging to the Regional Ministry of Health of Andalucía (Spain) and the Instituto de Salud Carlos III from the Spanish Ministry of Science. Calle Doctor Miguel Díaz Recio, 28 Málaga 29010 (Spain).
dc.description.version
dc.identifier.citationMorilla-Herrera JC, Morales-Asencio JM, Gómez-González AJ, Díez-De Los Ríos A, Lupiáñez-Pérez I, Acosta-Andrade C, et al. Effectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study). J Adv Nurs. 2020;76(8):2191-2197.
dc.identifier.doi10.1111/jan.14412
dc.identifier.essn1365-2648
dc.identifier.issn1365-2648
dc.identifier.pmcPMC7496185
dc.identifier.pmid32395842
dc.identifier.pubmedURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496185/pdf
dc.identifier.unpaywallURLhttps://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/jan.14412
dc.identifier.urihttp://hdl.handle.net/10668/15548
dc.issue.number8
dc.journal.titleJournal of advanced nursing
dc.journal.titleabbreviationJ Adv Nurs
dc.language.isoen
dc.organizationSAS - Hospital Costa del Sol
dc.organizationInstituto de Investigación Biomédica de Málaga - Plataforma Bionand (IBIMA)
dc.organizationSAS - D.S.A.P. Valle del Guadalhorce
dc.page.number2191–2197
dc.provenanceRealizada la curación de contenido 18/06/2025
dc.publisherWiley
dc.pubmedtypeJournal Article
dc.relation.publisherversionhttps://onlinelibrary.wiley.com/doi/10.1111/jan.14412
dc.rightsAttribution 4.0 International
dc.rights.accessRightsopen access
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectbacterial adhesion
dc.subjectbacterial load
dc.subjectleg injuries
dc.subjectnursing
dc.subjectvaricose ulcer
dc.subjectwound infections
dc.subject.decsÚlcera de la Pierna
dc.subject.decsBiopelículas
dc.subject.decsÚlcera
dc.subject.decsADN
dc.subject.decsCélulas Madre
dc.subject.decsSistema Inmunológico
dc.subject.decsReacción en Cadena de la Polimerasa
dc.subject.decsCarboximetilcelulosa de Sodio
dc.subject.decsCarga Bacteriana
dc.subject.meshUlcer
dc.subject.meshCarboxymethylcellulose Sodium
dc.subject.meshAnti-Bacterial Agents
dc.subject.meshBacterial Load
dc.subject.meshDrug Resistance, Bacterial
dc.subject.meshVaricose Ulcer
dc.subject.meshBiofilms
dc.subject.meshPolymerase Chain Reaction
dc.subject.meshDNA
dc.titleEffectiveness of a hydrophobic dressing for microorganisms' colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO-UV Study).
dc.typeprotocol
dc.type.hasVersionVoR
dc.volume.number76
dspace.entity.typePublication

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