Estudio Clínico para comparar la eficacia y tolerabilidad de la utilización de velos electrohilados para el tratamiento de pacientes quemados
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".