ArticleHeliyon2024
Defining critical quality attributes and composition parameters for burn wound dressings: Antibiotic-anesthetic films as a model.
Article in Heliyon, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Smart Polymeric Wound Dressings for Wound Treatment: Contributions and Applications.International journal of molecular sciences · 2026Review
- Biocidal Elastic Films Based on Cod Collagen, Pectin, and PMMA Copolymers: Effectiveness in Healing Burn Surfaces in Small Animals.Polymers · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The management of wounds primarily revolves around pain relief, effective infection control and the promotion of tissue regeneration to prevent complications like chronic skin wounds. While polymeric bioactive films are innovative alternatives to conventional wound dressings, there exists a dearth of guidance regarding their quality control. This underscores the imperative need to establish precise critical quality attributes, a task undertaken within this study using an antibiotic-anesthetic film as a model. The aim was to establish the influence of critical composition and process parameters and optimize the formula. First, the quality target product profile was defined, and critical quality attributes were identified. Our material selection included ciprofloxacin hydrochloride (an antimicrobial), lidocaine hydrochloride (an anesthetic), as well as excipients, such as sodium alginate, sodium hyaluronate, carbomer and glycerol. The critical components were identified through a risk assessment matrix, and their influence on film composition was determined by experimental verification using Design-Expert® software. A full factorial design was employed to assess the effects of sodium hyaluronate, carbomer and glycerol (as independent variables) on transparency, homogeneity, folding capacity and handling. Following this, an optimized formulation was achieved and subjected to further characterization. These optimized antibiotic-anesthetic films exhibited uniform micro-distribution of components, ensuring dosage uniformity. Both ciprofloxacin hydrochloride and lidocaine hydrochloride displayed sustained release profiles, suggesting potential therapeutic benefits for skin wounds. Furthermore, the resistance and elongation properties were similar to those of human skin. Utilizing a QbD approach, we successfully developed an optimized antibiotic-anesthetic film that adhered to the essential critical quality attributes. This films exhibits potential utility as a wound dressing. The findings presented in this study establish a fundamental framework for delineating the critical quality attributes of dressing films and refining their formulation to optimize wound treatment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.