Estudio Clínico para comparar la eficacia y tolerabilidad de la utilización de velos electrohilados para el tratamiento de pacientes quemados
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Notice bibliographique
Résumé
Introduction: Split-thickness skin autografts are the gold standard for surgical treatment of burns. In preclinical studies, the use of an electrospun poly(lactic-co-glycolide) acid (PLGA) bioveil, placed between autografts and their bed, has shown potential to stimulate dermal regeneration, increase graft take and improve scar quality. This bioveil also has potential as a drug delivery scaffold due to its three-dimensional structure and biodegradability. These properties have not yet been evaluated in human clinical trials. Objective: The primary goal of this study was to compare intra-individually the effectiveness and tolerability of the SKINHEALTEX PLGA bioveil used in conjunction with partial skin autografts for the treatment of debrided burns, compared to partial skin autografts alone. Materials and methods: A double-blind randomized controlled clinical trial was conducted with adult patients with burns that required surgical treatment, for 4 years (November 2018 to September 2022). Each patient acted as their own control, and they were followed for 12 months. In the control area an autograft was applied, while in the treatment area the PLGA bioveil was interposed between the autograft and the bed. The outcome variables were the percentage of graft take, evaluated clinically, the scar quality measured using the Vancouver Scar Scale and the Patient and Observer Scar Assesment Scale, and scar elasticity using a device based on the deformation after applying negative pressure. Blood test variables preoperatively and one month after surgery were also collected, as well as adverse events (phase I-II clinical trial, safety and effectiveness). Results: The bioveil was well tolerated in the 26 patients that were recruited. No adverse events related to the bioveil or laboratory changes suggestive of systemic effects were observed. No statistically significant differences were observed in partial skin autograft take and subsequent scar quality between the control group (partial skin autografts alone) and the autograft and SKINHEALTEX PLGA bioveil group. Conclusion: This is the first clinical trial investigating the application of an electrospun biomaterial in the treatment of burns using skin autografts. SKINHEALTEX PLGA is a biocompatible and safe product that can be applied as an interface between autografts and the debrided bed of a burn, without reducing graft take. The results of this sstudy suggest 7 potential of the PLGA bioveil as a possible route of administration for local therapies that increase graft take of autografts and/or improve the quality of the resulting scars in burn patients.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle