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Combined Primary Cleft Lip and Palate Repair: Is It Safe?

Kantar, Rami S; Rifkin, William J; Cammarata, Michael J; Maliha, Samantha G; Diaz-Siso, J Rodrigo; Farber, Scott J; Flores, Roberto L
BACKGROUND:Single-stage primary cleft lip and palate (PCLP) repair is controversial in the United States, and most patients are treated with a staged approach. In this study, early postoperative complications of the single-stage approach as compared to primary cleft lip (PCL) or primary cleft palate (PCP) alone were evaluated. This study represents the largest cohort of patients undergoing combined cleft lip and palate repair. METHODS:The American College of Surgeons National Surgical Quality Improvement Program-Pediatric database was used to identify patients undergoing single-stage PCLP, PCL, or PCP repairs. Preoperative factors and postoperative outcomes were compared between the 3 groups, as well as within the PCLP group between patients with and without complications. Univariate and multivariate analyses were performed. RESULTS:A TOTAL OF:: 181 patients were included in the single-stage PCLP group, 1007 in the PCP group and 783 in the PCL group. There was no difference in the rates of early complications between the 3 groups. Within the PCLP group, cardiac risk factors (β = 35.19; 95% confidence interval [CI] 7.88-75.21; P = 0.04) and complications (β = 77.31; 95% CI 35.82-118.79; P < 0.001) were significant risk factors for longer operative time. CONCLUSION/CONCLUSIONS:Analysis of a national database showed that single-stage PCLP repair is not associated with increased risk of early postoperative complications as compared to primary lip or palate repair alone. In-depth long-term analyses of craniofacial morphology, fistulae rate, speech, and dental outcomes are essential for a comprehensive assessment of the effects of combined cleft lip and palate repair.
PMID: 30531281
ISSN: 1536-3732
CID: 3957782

A Simple Protective Splint for Infant Nasal Reconstruction

Rifkin, William J; Maroutsis, Sandra; Bohsali, Sabrina A; Flores, Roberto L
Nasal trauma is a common complication of nasal continuous positive airway pressure (NCPAP) and may range from erythema, edema, and skin breakdown to columellar necrosis. Although rare, columellar necrosis can be a devastating complication following NCPAP, and surgical repair remains challenging due to contour and color-match difficulties, tenuous vascularity, and limited available adjacent skin. In addition, because operative site protection is critical to a successful repair, many surgeons opt to delay surgical intervention from infancy until a later age so that the patient does not inadvertently injure and compromise the graft during the early postoperative period. Here, we present a case of composite nasal reconstruction in an infant following columellar necrosis secondary to NCPAP, along with the design and implementation of a simple, inexpensive, and protective nasal splint that allows for early repair at the time of infancy.
PMID: 31136558
ISSN: 1550-1841
CID: 3957912

Assessment of American Cleft Palate-Craniofacial Association-Approved Teams' Websites for Patient-Oriented Content and Readability

Alfonso, Allyson R; DeMitchell-Rodriguez, Evellyn M; Ramly, Elie P; Noel, Daphney Y; Levy-Lambert, Dina; Wang, Maxime M; Kantar, Rami S; Flores, Roberto L
OBJECTIVE/UNASSIGNED:Informed decision-making relies on available information, including online resources. We evaluated the content and readability of websites published by American Cleft Palate-Craniofacial Association (ACPA)-approved cleft lip and/or palate (CLP) teams in the United States. DESIGN/UNASSIGNED:Team websites were reviewed, and teams with no accessible website or <30 sentences of content were excluded. Website content was scored by presence/absence of 20 variables derived from ACPA approval standards. Readability was evaluated with 8 scales. Readability was then compared to American Medical Association (AMA) recommendations. The relationship between website content and readability was assessed. MAIN OUTCOME MEASURE(S)/UNASSIGNED:Content and readability of team websites. RESULTS/UNASSIGNED:From 167 reviewed teams, 47 (28.1%) had nonfunctional links, 17 (10.2%) had no accessible website, and 39 (23.4%) had <30 sentences. The average content score for all 111 team websites included was 14.5 (2.6) of 20. The combined average reading level across all scales (10.7 [1.9]) exceeded the AMA-recommended sixth-grade reading level; this finding held true for each individual website. Children's Hospital-affiliated teams (n = 86) had a significantly higher content score (14.8 vs 13.5; P = .03) and better readability as evidenced by lower reading grade level (10.5 vs 11.4; P = .04). On linear regression, a higher content score significantly predicted better readability (β = -0.226; P < .001). CONCLUSIONS/UNASSIGNED:Websites published by ACPA-approved CLP teams vary in accessibility and content and exceed the recommended reading level. These findings could inform future efforts to improve patient-oriented resources.
PMID: 31129984
ISSN: 1545-1569
CID: 3948602

Long-term outcomes of 3D-printed bioactive ceramic scaffolds for regeneration of the pediatric skeleton

Chapter by: Wang, M. M.; Rodriguez Colon, R.; Kurgansky, G. D.; Witek, L.; Torroni, A.; Cronstein, B. N.; Flores, R. L.; Coelho, P. G.
in: Transactions of the Annual Meeting of the Society for Biomaterials and the Annual International Biomaterials Symposium by
[S.l. : s.n.], 2019
pp. 138-?
ISBN: 9781510883901
CID: 3913082

Dipyridamole Augments Three-Dimensionally Printed Bioactive Ceramic Scaffolds to Regenerate Craniofacial Bone

Lopez, Christopher D; Diaz-Siso, J Rodrigo; Witek, Lukasz; Bekisz, Jonathan M; Gil, Luiz F; Cronstein, Bruce N; Flores, Roberto L; Torroni, Andrea; Rodriguez, Eduardo D; Coelho, Paulo G
BACKGROUND:Autologous bone grafts remain a standard of care for the reconstruction of large bony defects, but limitations persist. The authors explored the bone regenerative capacity of customized, three-dimensionally printed bioactive ceramic scaffolds with dipyridamole, an adenosine A2A receptor indirect agonist known to enhance bone formation. METHODS:Critical-size bony defects (10-mm height, 10-mm length, full-thickness) were created at the mandibular rami of rabbits (n = 15). Defects were replaced by a custom-to-defect, three-dimensionally printed bioactive ceramic scaffold composed of β-tricalcium phosphate. Scaffolds were uncoated (control), collagen-coated, or immersed in 100 μM dipyridamole. At 8 weeks, animals were euthanized and the rami retrieved. Bone growth was assessed exclusively within scaffold pores, and evaluated by micro-computed tomography/advanced reconstruction software. Micro-computed tomographic quantification was calculated. Nondecalcified histology was performed. A general linear mixed model was performed to compare group means and 95 percent confidence intervals. RESULTS:Qualitative analysis did not show an inflammatory response. The control and collagen groups (12.3 ± 8.3 percent and 6.9 ± 8.3 percent bone occupancy of free space, respectively) had less bone growth, whereas the most bone growth was in the dipyridamole group (26.9 ± 10.7 percent); the difference was statistically significant (dipyridamole versus control, p < 0.03; dipyridamole versus collagen, p < 0.01 ). There was significantly more residual scaffold material for the collagen group relative to the dipyridamole group (p < 0.015), whereas the control group presented intermediate values (nonsignificant relative to both collagen and dipyridamole). Highly cellular and vascularized intramembranous-like bone healing was observed in all groups. CONCLUSION:Dipyridamole significantly increased the three-dimensionally printed bioactive ceramic scaffold's ability to regenerate bone in a thin bone defect environment.
PMID: 31033822
ISSN: 1529-4242
CID: 3854182

Midface Growth in Patients With Unilateral Cleft Lip and Palate Treated With a Nasoalveolar Molding Protocol

Rubin, Marcie S; Clouston, Sean A P; Esenlik, Elçin; Shetye, Pradip R; Flores, Roberto L; Grayson, Barry H
This retrospective cohort study aimed to determine the impact of a nasoalveolar molding (NAM) protocol on midface growth in school-aged children with non-syndromic unilateral cleft lip and palate (UCLP). Data from 56 consecutively treated, NAM-prepared, Caucasian patients with non-syndromic UCLP from a single US cleft palate center were compared to pooled center data based on 56 patients with non-syndromic UCLP treated at 2 Eurocleft centers that did not use presurgical infant orthopedics (non-PSIO). Lateral cephalograms were obtained and 28 landmarks were identified. Published cephalometric measurements from Eurocleft centers were used for comparison. Seven cephalometric measurements (SNA, SNB, ANB, A'N'B', G'-Sn'-Pg', Sn-CT-LS, ANS-Me/N-Me%), available or derivable for both centers, were analyzed. Means and standard deviations for the 7 measurements were calculated for the NAM center. Student's t-tests were used to compare group means for 6 of the measures and a test of proportion was used for ANS-Me/N-Me%. No significant differences were found between the NAM protocol-prepared group and the Eurocleft non-PSIO centers on any of the 7 analyzed cephalometric relationships after accounting for false discovery rate. The NAM treatment protocol does not appear to impact skeletal or soft tissue facial growth in school-aged children with non-syndromic UCLP.
PMID: 30950956
ISSN: 1536-3732
CID: 3826272

Three-Dimensional Affordable Stone Models for Cleft Lip Markings: A Prospective Study of Learner Satisfaction

Kantar, Rami S; Gonchar, Marina; Maliha, Samantha G; Ramly, Elie P; Alfonso, Allyson R; Cohen, Oriana; Eisemann, Bradley S; Diaz-Siso, J Rodrigo; Saadeh, Pierre B; Flores, Roberto L
INTRODUCTION/BACKGROUND:Knowledge of surgical markings for unilateral cleft lip (UCL) repair is critical for surgical competency. However, few appropriate models are accessible to residents and affordable and accurately reproduce this 3-dimensional (3D) deformity. We propose that cleft care units have the capability of creating affordable 3D stone models to teach UCL markings. METHODS:Polyvinyl siloxane and SnapStone were used to create UCL stone models. Thirteen plastic surgery residents were prospectively recruited, provided with a textbook chapter and online module for studying surgical markings for UCL repair, and then asked to perform the markings on a UCL stone model and standardized patient photograph. Learner satisfaction was evaluated using a modified survey based on the Student Evaluation of Educational Quality survey. RESULTS:The production time of each model was 10 minutes, whereas the cost was $1.84. Participants reported that the stone model was more stimulating (4.77 ± 0.44 vs 3.92 ± 0.86; U = 38.0; P = 0.008), increased their interest more (4.70 ± 0.48 vs 3.53 ± 1.20; U = 33.5; P = 0.005), allowed better learning (4.61 ± 0.51 vs 3.08 ± 0.86; U = 10.0; P < 0.001), was clearer (4.62 ± 0.51 vs 3.15 ± 0.90; U = 12.5; P < 0.001), and was more effective for learning cleft lip markings (4.77 ± 0.44 vs 3.08 ± 1.04; U = 9.0; P < 0.001). They were also more likely to recommend it (4.85 ± 0.38 vs 3.15 ± 1.07; U = 7.0; P < 0.001). CONCLUSIONS:Plastic surgery residents report that 3D cleft lip stone models are superior training tools to learn cleft lip markings compared with patient photographs. These educational tools have the potential to overcome significant financial, logistic, and time constraints in teaching cleft lip surgery markings.
PMID: 31008789
ISSN: 1536-3708
CID: 3821312

Foundation-Based Cleft Care in Developing Countries

Kantar, Rami S; Cammarata, Michael J; Rifkin, William J; Diaz-Siso, J Rodrigo; Hamdan, Usama S; Flores, Roberto L
BACKGROUND:Cleft deformities of the lip and palate affect nearly one in 500 to 700 births, and lead to increased morbidity and mortality if untreated. Nevertheless, significant global disparities in access to timely and appropriate care still exist. The relatively basic infrastructure required to surgically correct these deformities and large unmet disease burden have resulted in a significant number of foundation-based cleft care initiatives focused on developing countries. In this study, the authors evaluate the peer-reviewed literature generated by these foundations in an attempt to assess their clinical, scientific, educational, and economic impact. METHODS:A comprehensive review of the literature was performed using key search terms, and the level of evidence of identified articles was determined. Data were then analyzed to determine the different models of foundation-based cleft care in developing countries, and their clinical, scientific, educational, and economic impact. RESULTS:A total of 244 articles were identified through the authors' search and reviewed. Foundation-based cleft care initiatives in developing countries have significantly contributed to a better understanding of disease epidemiology, barriers to care, safety considerations, complications and outcomes, and international and local cleft surgery education. The cleft care center model is more cost-effective than the surgical mission model and provides more sustainable care. CONCLUSIONS:Foundation-based cleft care prevents significant morbidity in developing countries and has provided valuable resources for capacity building. The surgical mission model should be considered as a transitory conduit for establishing the more effective and sustainable cleft care center model of care.
PMID: 30921141
ISSN: 1529-4242
CID: 3778902

The Nasoalveolar Molding (NAM) Treatment Protocol

Flores, Roberto L; Shetye, Pradip R
PMID: 30884969
ISSN: 1545-1569
CID: 3734912

Effect on Facial Growth of the Management of Cleft Lip and Palate

Farber, Scott J; Maliha, Samantha G; Gonchar, Marina N; Kantar, Rami S; Shetye, Pradip R; Flores, Roberto L
Treatment of cleft lip and palate ordinarily requires multiple interventions spanning the time of birth to adulthood. Restriction of facial growth, a common occurrence in affected children, is due to multiple factors. There are multiple surgical and therapeutic options, which may have influence on facial growth in these patients. As restriction to facial development can have significant implications to form, function, and psychological well-being, practitioners should have an appreciation for the effects of the different cleft therapies to facial growth. We have outlined and thoroughly reviewed in chronological order all of the interventions from birth to adulthood necessary in the comprehensive care of the patient with cleft lip and palate, along with the effects they may or may not have on facial growth.
PMID: 30882417
ISSN: 1536-3708
CID: 3734822