An innovative, highly conformable, mesh-free healing matrix dressing: results of a clinical trial
Notice bibliographique
Résumé
OBJECTIVE: The aim of this clinical trial was to evaluate the performance and local tolerance of an innovative mesh-free contact layer (healing matrix) made of lipidocolloid technology (TLC) in the management of various wounds. This dressing is made highly flexible by the absence of textile mesh in its core. METHOD: A four-week, prospective, multicentre clinical trial was conducted on the evaluated dressing (UrgoFit, Laboratoires Urgo, France) in 23 centres in France. Eligible patients were adults with a cutaneous wound of acute or chronic origin or due to epidermolysis bullosa (EB) in the granulation stage. The primary endpoint was the relative wound area reduction (RWAR) at week 4. Secondary endpoints included wound closure rate and time-to-heal, as well as dressing change frequency, pain at dressing removal, local tolerance and acceptability of the dressing. RESULTS: A total of 78 adult patients (23-95 years old) were treated with the dressing over a period of 24±8 days. Wound aetiologies included: postoperative or traumatic finger wounds; skin graft donor sites; dermabrasions/skin tears; burns; leg ulcers (LUs) of predominantly venous origin; a stage 3 pressure injury; and EB lesions. The median RWAR at week 4 was 98.2% (ranging between 61.5-100.0%, depending on wound types). Complete closure was achieved in 49% of patients (59% in acute wounds, 60% in EB lesions and 16% in chronic wounds) with a median time-to-heal of 16.5 days (ranging between 14.5-27.0 days, depending on wound types). Half of LUs reached a RWAR ≥40% at week 4, a predictive indicator of complete wound healing at week 24. Dressings were changed every 2±1 days on average (and left in place for a maximum of 10 days). Since the first application, the dressing was judged by healthcare professionals (HCPs) to be 'very easy' or 'easy' to apply on 96% of wounds, with a 'very good' or 'good' conformability to 94% of wound beds. Similar results were reported in cases of finger/hand wounds. Since the first week of treatment, the dressing removal was also judged 'very easy' or 'easy' in 95-98% of the cases, protecting and preserving newly formed tissue in 100% of cases. At the first follow-up visit, patients reported the dressing changes to be painless in 95% of cases. This represented a significant improvement over the previous dressings they received (p<0.0001). In all, seven non-serious adverse events related to the dressing were reported during the study period. CONCLUSION: In this clinical trial, the innovative mesh-free TLC dressing was shown to promote wound healing, to be well tolerated and well accepted by patients and HCPs, in line with the evidence available on other TLC dressings; however, its enhanced conformability may provide an additional benefit for the management of wounds.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
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 | 0,001 |
| 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 | 0,000 | 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 découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».