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Silk and silk derivatives have emerged as a possible alternative in surgical device development, offering mechanical strength, biocompatibility, and environmental sustainability. Through a systematic review following PRISMA guidelines, this study evaluated silk fibroin's application across pre-clinical and clinical settings, focusing on its role as screws and plates for osteofixation. A comprehensive search yielded 245 studies, with 33 subjected to full-text review and 15 ultimately included for qualitative analysis. The findings underscore silk fibroin's superior properties, including its tunable degradation rates and ability to be functionalized with therapeutic agents. In vivo and in vitro studies demonstrated its efficacy in enhancing bone healing, offering improved outcomes in osteofixation, particularly for craniofacial defects. Silk fibroin's remarkable attributes in biodegradation and drug release capabilities underscore its potential to enhance patient care. Ultimately, silk fibroin's integration into surgical practices promises a revolution in patient outcomes and environmental sustainability. Its versatility, coupled with the continuous progress in fabrication techniques, signals a promising horizon for its widespread acceptance in the medical field, potentially establishing a new benchmark in surgical treatment. Further research is expected to solidify the transition of silk products from basic science to patient care, paving the way for widespread use in various surgical applications.
RESUMO
BACKGROUND: Patient-reported outcomes (PROs) have evolved to validated questionnaires assessing health-related quality of life. This systematic review evaluates the utilization of PROs in United States plastic and reconstructive surgery (PRS) clinical trials (CTs). METHODS: A medical librarian conducted a search strategy for PRS CTs from 2012 to 2022. CTs were identified and assessed for PRO utilization. Summary statistics were performed, and Fisher's exact test was used for subgroup analysis. RESULTS: Of the 3609 studies initially identified, 154 were PRS CTs. Approximately half (80 studies) employed PROs, encompassing 13,190 participants, 95% (12,229) of whom were female. Among the CTs, 37 (48%) were in the field of reconstruction, while 25 (32%) were cosmetic. Pain (35%) and patient satisfaction (24%) were the most common primary outcomes. Validated PROs were the main outcome in 61% of these trials, with the visual analog scale (19%) and BREAST-Q (15%) as the top instruments. Funding was primarily private (34%) or not reported (49%). No significant trend in validated PRO usage was observed over the examined decade. CONCLUSIONS: The use of PROs is relevant for healthcare delivery and improvement as they provide insight into the efficacy of treatments from a patient-centered viewpoint. PROs are reported in just over half of PRS CTs, and within those CTs, the use of validated questionnaires is inconsistent. Therefore, emerging CTs should strive to incorporate PRO measures and utilize the existing validated tools to assess novel interventions and ensure that the data reported is objective.
Assuntos
Ensaios Clínicos como Assunto , Medidas de Resultados Relatados pelo Paciente , Procedimentos de Cirurgia Plástica , Humanos , Procedimentos de Cirurgia Plástica/estatística & dados numéricos , Satisfação do Paciente/estatística & dados numéricos , Qualidade de Vida , Cirurgia Plástica/estatística & dados numéricos , Estados Unidos , Inquéritos e QuestionáriosRESUMO
In 1993, the National Institutes of Health Revitalization Act mandated increasing minority and women enrollment in clinical trials (CTs). This study aimed to investigate trends in race and ethnicity enrollment and reporting in US plastic and reconstructive surgery (PRS) CT. METHODS: A comprehensive systematic review was performed. All CTs in PRS from 2012 to 2022 were included. To assess racial and ethnic representation within CTs, a random-effects meta-analysis of proportion was conducted to pool the prevalence of the binomial data. RESULTS: A total of 3609 studies were initially identified in the search strategy, with 154 later classified as CTs in PRS. Only 36 met the eligibility criteria for reporting race and ethnicity and were included in the analysis. A total of 7281 participants were included: 446 (6.1%) males and 6835 (93.9%) females. From CTs that correctly reported race, the pooled prevalence of races were as follows: Whites 78% (95% confidence interval [CI] 73-82%), Black or African Americans 8% (95% CI 5-11%), Asians 1% (95% CI <1-2%), American Indians <1% (95% CI <1-<1%), and Pacific Islanders <1% (95% CI <1-<1%). From the studies that reported ethnicity correctly, the pooled prevalence of Hispanics was 7% (95% CI 5-9%), and Non-Hispanics was 12% (<1-38%). CONCLUSIONS: Disparities in minority representation were present among PRS CTs. This suggests clear limitations in generalizing PRS CT results to the population. Efforts to decrease the gap in minority enrollment and accurately report race and ethnicity are needed in all fields, including plastic surgery.