Searched for: school:SOM
Department/Unit:Plastic Surgery
Second-Degree Burns and Aloe Vera: A Meta-analysis and Systematic Review
Sharma, Sonali; Alfonso, Allyson R; Gordon, Alex J; Kwong, Jennifer; Lin, Lawrence J; Chiu, Ernest S
OBJECTIVE:Aloe vera is a cost-effective, accessible wound care adjunct with a minimal risk profile. Despite its centuries-long history being used to treat varying wound types, published reports remain inconclusive on its efficacy. In this article, the authors report the results of a systematic review assessing the efficacy of topical aloe vera products in wound care applications, as well as a meta-analysis of its utility in burn healing where data are most robust. DATA SOURCES/METHODS:In accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, the authors searched PubMed, EMBASE, and Cochrane CENTRAL for randomized controlled trials assessing the use of aloe vera in healing various wound types. STUDY SELECTION/METHODS:The database search identified 91 articles. After duplicates were removed, 74 articles were screened, and of those, 47 were assessed for eligibility. Ultimately, 28 articles were included in the qualitative synthesis, and 4 studies assessing second-degree burns were included in the meta-analysis. DATA EXTRACTION/METHODS:The following data points were collected from each study: number of participants/wounds, treatment type, adjunctive therapy (if any), and primary outcomes. DATA SYNTHESIS/RESULTS:Risk-of-bias analysis was conducted on included articles, and results were compiled. A meta-analysis was undertaken for studies focusing on the treatment of burns. Cumulatively, these studies had a total of 133 patients with 163 wounds being assessed. Analysis revealed a statistically significant mean difference in time to healing of 4.44 days in favor of aloe vera treatment (P = .004). CONCLUSIONS:Topical aloe vera usage for second-degree burn wound healing demonstrated significantly faster time to healing compared with other treatments.
PMID: 36264753
ISSN: 1538-8654
CID: 5352492
Perspectives of Academic Oncologists About Offering Expanded Access to Investigational Drugs
Gould, Patrick; Salam, Tasnim; Kimberly, Laura; Bateman-House, Alison; Fernandez Lynch, Holly
Importance/UNASSIGNED:The expanded access (EA) pathway permits patients to be treated with investigational medical products outside clinical trials. Because cancer care is a common indication for which EA is sought and these efforts require physician management, understanding oncologists' perspectives can help illuminate factors influencing patient access. Objective/UNASSIGNED:To learn how oncologists practicing at academic medical centers (AMCs) perceive EA and their role in offering it. Design, Setting, and Participants/UNASSIGNED:This qualitative study used data from semistructured interviews conducted from February 2020 to September 2021 with a purposive sample of oncologists recruited from large, urban AMCs in the northeast United States. Oncologists who had submitted at least 1 single-patient EA request to the institutional review boards at the University of Pennsylvania, Children's Hospital of Philadelphia, NYU Langone Health, and Dana-Farber Cancer Institute from January 1, 2014, through January 31, 2020, were eligible to participate. Data were analyzed from July 2021 to March 2022. Main Outcomes and Measures/UNASSIGNED:Interviews focused on oncologist practice demographics, experience with EA, factors relevant to decisions to pursue EA and comfort with those decisions, perspectives on oncologists' role in EA, perspectives on the FDA's role, and the Right to Try pathway to access investigational drugs. Results/UNASSIGNED:Eligible oncologists were interviewed until thematic saturation was reached, resulting in 25 interviews; most participants were women (15 participants [60%]), reported primarily treating adult patients (15 participants [60%]), had more than 10 years of clinical experience (16 participants [64%]), and had submitted at least 2 single-patient EA requests to their institutional review boards during the relevant period (14 participants [56%]). Oncologists viewed EA as an important tool for securing what they determined to be the best treatment option for their patients based on their own expert assessment of available data. Interviewees reported that they would rather access interventions as commercially available products or through clinical trials; however, if the preferred option was not available through these means, they viewed pursuit of EA as part of their obligation to patients, while often recognizing the potential for inequities in the broader patient population beyond their institutions. Participating oncologists felt confident pursuing investigational drugs for treatment use, despite the absence of FDA marketing approval, and did not necessarily view EA as a last resort. Conclusions and Relevance/UNASSIGNED:These findings indicate that oncologists practicing in large academic settings sought to treat patients with the interventions they deemed most likely to be beneficial, regardless of approval status. As such, they viewed EA as an unexceptional means to obtain promising products, although it remains unclear whether their confidence in evaluating investigational treatments was justified. Future research should examine whether oncologists outside large AMCs share this confidence, as differences may influence patient access to the EA treatment pathway.
PMID: 36318206
ISSN: 2574-3805
CID: 5358252
Current Presurgical Infant Orthopedics Practices Among American Cleft Palate Association-Approved Cleft Teams in North America
Avinoam, Shayna P; Kowalski, Haley R; Chaya, Bachar F; Shetye, Pradip R
Presurgical infant orthopedic (PSIO) therapy has evolved in both its popularity and focus of treatment since its advent. Nasoalveolar molding, nasal elevators, the Latham appliance, lip taping, and passive plates are the modern treatment options offered by cleft teams. Many cleft surgeons also employ postsurgical nasal stenting (PSNS) after the primary lip repair procedure. The purpose of this study is to examine trends in current PSIO care as well as PSNS for the management of patients with cleft lip and palate. An electronic survey was distributed to cleft team coordinators listed by the American Cleft Palate Association. The survey reported on team setting, provider availability, PSIO offerings, contraindications, and use of PSNS. Descriptive statistics and analyses were performed using MS Excel and SPSS. A total of 102 survey responses were received. The majority of settings were children's specialty hospitals (66%) or university hospitals (27%). Presurgical infant orthopedics was offered by 86% of cleft teams, and the majority of those (68%) provided nasoalveolar molding. Nasal elevators and lip taping are offered at 44% and 53% of centers, respectively. Latham and passive plates are both offered at 5.5% of centers. Most centers had an orthodontist providing treatment. The majority of centers use PSNS (86%). Nasoalveolar molding is the most popular PSIO technique in North American cleft centers followed by the nasal elevator, suggesting that the nasal molding component of PSIO is of critical influence on current treatment practices.
PMID: 36409871
ISSN: 1536-3732
CID: 5371992
Stability of fatigued and aged ZTA compared to 3Y-TZP and Al2O3 ceramic systems
Benalcázar Jalkh, Ernesto B; Bergamo, Edmara T P; Campos, Tiago M B; de Araújo-Júnior, Everardo N S; Lopes, Adolfo C O; Tebcherani, Sérgio M; Yamaguchi, Satoshi; Genova, Luis A; Gierthmuehlen, Petra C; Witek, Lukasz; Coelho, Paulo G; Bonfante, Estevam A
To evaluate the effect of fatigue and aging on the crystalline content and reliability of a zirconia-toughened-alumina (ZTA) composite compared to its individual counterpart materials (3Y-TZP and Al2O3). Thirty-six disc-shaped specimens per group were obtained to comply with ISO 6872:2015. Crystalline content, microstructure and reliability of experimental groups were evaluated in four stages: 1) immediate; 2) aged; 3) fatigued; 4) aged + fatigue. Aging was performed in autoclave and Step-Stress-Accelerated-Life-Testing (SSALT) was performed using three stress profiles. Weibull statistics were used to determine Weibull parameters and life-expectancy. A significant increase in monoclinic phase in 3Y-TZP was observed after aging (19.31%), fatigue (17.88%) and aging + fatigue (55.81%), while ZTA evidenced minimal variation among all conditions (<5.69%). 3Y-TZP presented higher reliability than ZTA at 300 and 500 MPa, and ZTA outperformed Al2O3 at the same stress missions. None of the ceramics yielded acceptable reliability at 800 MPa. A higher characteristic strength was observed for 3Y-TZP, followed by ZTA and Al2O3. While after aging ZTA and Al2O3 remained stable, 3Y-TZP exhibited a significant increase in the characteristic stress. Aging did not affect the reliability of ZTA and Al2O3. 3Y-TZP demonstrated an increase in monoclinic content and characteristic strength after aging.
PMID: 36162164
ISSN: 1878-0180
CID: 5374842
Behind the scenes of extracellular vesicle therapy for skin injuries and disorders
Subhan, Bibi Sheleeza; Ki, Michelle; Verzella, Alexandra; Shankar, Shruthi; Rabbani, Piul
SIGNIFICANCE/CONCLUSIONS:Skin wounds and disorders compromise the protective functions of skin and patient quality of life. Though accessible on the surface, they are challenging to address due to paucity of effective therapies. Exogenous extracellular vesicles (EVs), cell-free derivatives of adult multipotent stromal cells (MSCs), are developing as a treatment modality. Knowledge of origin MSCs, EV processing and mode of action is necessary for directed use of EVs in preclinical studies and methodical translation. Recent advances: Nano to microscale EVs, though from non-skin cells, induce functional responses in cutaneous wound cellular milieu. EVs allow a shift from cell-based to cell-free/derived modalities by carrying the MSC beneficial factors but eliminating risks associated with MSC transplantation. EVs have demonstrated striking efficacy in resolution of preclinical wound models, specifically within the complexity of skin structure and wound pathology. CRITICAL ISSUES/RESULTS:To facilitate comparison across studies, tissue sources and processing of MSCs, culture conditions, isolation and preparations of EVs, and vesicle sizes require standardization as these criteria influence EV types and contents, and potentially determine the induced biological responses. Procedural parameters for all steps preceding the actual therapeutic administration may be the key to generating EVs that demonstrate consistent efficacy through known mechanisms. We provide a comprehensive review of such parameters and the subsequent tissue, cellular and molecular impact of the derived EVs in different skin wounds/disorders. FUTURE DIRECTIONS/CONCLUSIONS:We will gain more complete knowledge of EV-induced effects in skin, and specificity for different wounds/conditions. The safety and efficacy of current preclinical xenogenic applications will favor translation into allogenic clinical applications of EVs as a biologic.
PMID: 34806432
ISSN: 2162-1918
CID: 5063312
Gender Affirmation Surgery on the Rise: Analysis of Trends and Outcomes
Chaya, Bachar F; Berman, Zoe P; Boczar, Daniel; Trilles, Jorge; Siringo, Nicolette V; Diep, Gustave K; Rodriguez Colon, Ricardo; Rodriguez, Eduardo D
PMID: 36251926
ISSN: 2325-8306
CID: 5360262
Probability of survival and failure mode of endodontically treated incisors without ferrule restored with CAD/CAM fiber-reinforced composite (FRC) post-cores
Bergamo, Edmara T P; Lopes, Adolfo C O; Campos, Tiago M B; Amorim, Pedro Henrique; Costa, Fábio; Benalcázar Jalkh, Ernesto B; Carvalho, Laura F de; Zahoui, Abbas; Piza, Mariana M T; Gutierres, Eliezer; Witek, Lukasz; Bonfante, Estevam A
PURPOSE/OBJECTIVE:This study evaluated the probability of survival and failure mode of endodontically treated incisors without ferrule restored with CAD/CAM FRC post-cores. METHODS:Root canals of bovine incisors were treated, leaving post preparations of ∼10 mm. Teeth were allocated into three groups: (i) cast metal post-core, (ii) FRC prefabricated post with a direct resin core build-up, and (iii) CAD/CAM FRC post-core. Posts and zirconia crowns were cemented using resin cement. Specimens were subjected to step-stress accelerated-life fatigue testing in water. Use level probability Weibull curves, probability of survival for a mission of 100,000 cycles at 25, 50, and 100 N, Weibull modulus, and characteristic strength were calculated and plotted. Failure mode was examined under a stereomicroscope. RESULTS:Restored incisors demonstrated high probability of survival (93-100%) for missions estimated at 25 and 50 N, irrespective of post-core foundation. At 100 N, incisors restored with metal posts presented significantly higher probability of survival (99%) relative to CAD/CAM posts (79%), whereas FRC groups demonstrated no significant difference. Weibull analysis indicated no significant difference on the Weibull modulus (m = 3.38-5.92). Incisors reconstructed with metal post-cores (431 N) presented significantly higher characteristic strength relative to prefabricated (200 N) and CAD/CAM (202 N) FRC post-cores. While post fracture was the chief failure mode for prefabricated and CAD/CAM FRC post-cores, post and/or root fracture were the main event for metal post-cores. CONCLUSION/CONCLUSIONS:Endodontically treated incisors without ferrule restored with CAD/CAM FRC post-cores presented promising probability of survival for loads compatible with anterior masticatory forces and favorable failure modes.
PMID: 36279744
ISSN: 1878-0180
CID: 5365812
Patient-specific 3D printed Poly-ether-ether-ketone (PEEK) dental implant system
Sonaye, Surendrasingh Y; Bokam, Vijay K; Saini, Akshay; Nayak, Vasudev V; Witek, Lukasz; Coelho, Paulo G; Bhaduri, Sarit B; Bottino, Marco C; Sikder, Prabaha
Fused Filament Fabrication (FFF)-based 3D printing is an efficient technique for developing medical implants, but it is not very useful in developing small yet mechanically robust design-specific fixtures such as dental implants (<15 mm). Specifically, it is challenging to 3D print robust Polyetheretherketone (PEEK) small implants due to PEEK's high melting temperature and melt viscosity. However, in this study, we efficiently utilize high-temperature FFF to develop the first-of-its-kind patient-specific robust PEEK dental implants with high print resolution. Specifically, we explore the effects of critical FFF processing conditions on the mechanical properties of the implants and subsequently determine an optimized set of processing conditions that are essential in developing durable dental implant systems. Our results indicate that the 3D printed dental implants exhibit good fatigue properties and suffice the clinical and industrial requirements for dental implants. Furthermore, we prove that the 3D printed implants exhibit adequate mechanical durability even after simulated (accelerated) aging of 30 years.
PMID: 36244326
ISSN: 1878-0180
CID: 5374892
Hand Therapy Regimen for Functional Recovery Following Combined Face and Bilateral Hand Transplantation
Boczar, Daniel; Seu, Monica; O'Connell, April; Gersh, Eugene; Chaya, Bachar F; Berman, Zoe; Ruiz, Natalia; Welsh, Laura; Rodriguez, Eduardo D
Intensive postoperative rehabilitation therapy is associated with positive functional recovery in hand transplants (HTs). Our goal is to share the hand therapy protocol developed for our patient who underwent a combined face and bilateral HT. The patient is a 23-year-old right-hand-dominant male with a history of third-degree burns to 80% of his body following a motor vehicle accident. A multidisciplinary evaluation established his candidacy for a combined face and bilateral HT, and surgery took place in August 2020. Our individualized hand therapy protocol consisted of 4 phases. The pre-surgery phase focused on planning the orthotics and patient/caregivers' education on the rehabilitation process. The intensive care unit (ICU)/acute care phase involved hand allograft protection and positioning via orthotic fabrication, safe limb handling, and edema/wound management. The inpatient rehabilitation phase aimed to prepare the patient for independent living via neuromuscular and sensory re-education, improvement of upper extremities strength/flexibility, training basic activities of daily living, and providing a home exercise program (HEP). Finally, the outpatient phase aimed to maximize our patient's range of motion and independency in performing his routine activities and HEP. The patient's post-transplant functional outcomes showed a significant improvement compared to the pre-operative baseline. We hope this report sheds light on a comprehensive hand therapy program in HT.
PMID: 36214276
ISSN: 1558-9455
CID: 5360832
Clinical Outcomes in Orthognathic Surgery for Craniofacial Microsomia Following Mandibular Distraction Using CBCT Analysis: A Retrospective Study
DeMitchell-Rodriguez, Evellyn M; Mittermiller, Paul A; Avinoam, Shayna P; Staffenberg, David A; Rodriguez, Eduardo D; Shetye, Pradip R; Flores, Roberto L
OBJECTIVE:The aim of this study was to evaluate the outcomes of orthognathic surgery (OGS) in patients with craniofacial microsomia (CFM) who had previously undergone mandibular distraction osteogenesis (MDO). DESIGN/METHODS:A retrospective cohort study was performed including all patients with CFM who were treated with OGS at a single institution between 1996 and 2019. The clinical records, operative reports, and cone beam computed tomography (CBCT) scans were reviewed. CBCT data before OGS (T1), immediately after OGS (T2), and at long-term follow-up (T3) were analyzed using Dolphin three-dimensional software to measure the occlusal cant and chin point deviation. RESULTS:  =  .808). CONCLUSIONS:Within the limitations of this study, these findings suggest that OGS after MDO in patients with CFM can produce stable results.
PMID: 36205083
ISSN: 1545-1569
CID: 5351712