Reducing Retained Foreign Objects in the Operating Room: A Quality Improvement Initiative.

BACKGROUND: Although the incidence of pediatric retained foreign objects (RFOs) during surgery is diminutive (1/32,000), RFOs are often the most common sentinel events reported. In 2021, our institution noted an increase in RFOs evidenced by a substantial decrease in days between events. We aimed to minimize the incidence of RFO which was measured as an increase of days between events at our institution by implementation of a Quality Improvement initiative. STUDY DESIGN: This effort was conducted across 4 surgical centers within a tertiary children's healthcare system in December 2021. Patients undergoing surgery within this healthcare system across all surgical specialties were included. The quality improvement initiative was developed by a multidisciplinary team and included 6 steps focusing on quiet time, minimizing interruptions, and closed-loop communication during final surgical count. Seven Plan-Do-Study-Act cycles were used to test, refine, and implement the protocol. Adherence to the final surgical count protocol was monitored throughout the study period. RESULTS: In 2021, before protocol implementation, average time between RFO events was 29 days. After implementation of our quality initiative, the final surgical count protocol, we improved to 451 days between RFO events by February 2023, exceeding the upper control limit (235 days). After implementation, the number of RFO events dropped from 7 in 2021 to 0 in 2022. Adherence to the final surgical count protocol implementation was 96.4% by the end of cycle 7. CONCLUSIONS: RFOs during pediatric surgical procedures can be successfully reduced using quality improvement methodology focusing on standardizing the procedure of the final surgical count.

Short-term Satisfaction, Psychosocial Impact, and Complication Profile of Reduction Mammaplasty During Adolescence.

BACKGROUND: Reduction mammaplasty is an effective and safe treatment option for adults with symptomatic macromastia, but there are few data regarding outcomes in adolescents. OBJECTIVES: The purpose of this study was to determine the short-term psychosocial impact, satisfaction, and safety of reduction mammaplasty when performed during adolescence. METHODS: A retrospective review was performed of a single pediatric plastic surgeon's experience with reduction mammaplasty from 2018 to 2021 in patients aged ≤18 years. Patients completed the preoperative and postoperative "Satisfaction with Breasts" and "Psychosocial Well-being" sections of the BREAST-Q survey. Clinical variables gathered included age, weight, BMI, complication profile, specimen resection weight, and follow-up duration. RESULTS: In total, 41 patients met inclusion criteria. The mean converted Rasch scores for BREAST-Q "Satisfaction with Breasts" and "Psychosocial Well-being" increased significantly following reduction mammaplasty ("Satisfaction with Breasts": preoperative, 24.1 vs postoperative, 92.6; "Psychosocial Well-being": preoperative, 37.7 vs postoperative, 90.4; P < .001). Obesity (BMI ≥ 30 kg/m2) was associated with lower preoperative "Psychosocial Well-being" scores (obese, 29.7 vs nonobese, 43.3; P < .001) but a greater improvement in score following surgery (obese, +63.9 vs nonobese, +44.9; P < .001). Specimen weight ≥1000 grams was also associated with greater improvement in score on the "Psychosocial Well-being" section (≥1000 grams, +58 vs <1000 grams, +49.7; P = .046). Overall complication rate was 31.7% while the major complication rate was 2.4%. Mean specimen resection weight was higher in patients who experienced complications (1141.3 grams vs 836.8 grams, P = .008). CONCLUSIONS: Reduction mammaplasty during adolescence predictably improves both short-term satisfaction with breasts and psychosocial well-being while demonstrating a favorable short-term complication profile.

Needle-free, spirulina-produced Plasmodium falciparum circumsporozoite vaccination provides sterile protection against pre-erythrocytic malaria in mice.

Antibodies against the Plasmodium falciparum circumsporozoite protein (PfCSP) can block hepatocyte infection by sporozoites and protect against malaria. Needle-free vaccination strategies are desirable, yet most PfCSP-targeted vaccines like RTS,S require needle-based administration. Here, we evaluated the edible algae, Arthrospira platensis (commonly called 'spirulina') as a malaria vaccine platform. Spirulina were genetically engineered to express virus-like particles (VLPs) consisting of the woodchuck hepatitis B core capsid protein (WHcAg) displaying a (NANP)15 PfCSP antigen on its surface. PfCSP-spirulina administered to mice intranasally followed by oral PfCSP-spirulina boosters resulted in a strong, systemic anti-PfCSP immune response that was protective against subcutaneous challenge with PfCSP-expressing P. yoelii. Unlike male mice, female mice did not require Montanide adjuvant to reach high antibody titers or protection. The successful use of spirulina as a vaccine delivery system warrants further development of spirulina-based vaccines as a useful tool in addressing malaria and other diseases of global health importance.

Mandibular Distraction in Neonatal Pierre Robin Sequence: Is Immediate Extubation Both Feasible and Safe?

BACKGROUND: The timing of extubation following placement of mandibular distractors in the setting of Pierre Robin sequence is variable across institutional algorithms. Postoperative maintenance of intubation allows for an improvement in airway dimension and tongue positioning before extubation, theoretically decreasing the impact of postoperative airway edema. Maintenance of intubation, however, is not without risk. The authors analyze their institutional experience with neonatal mandibular distraction followed by immediate extubation to assess feasibility and safety profiles. METHODS: A 4-year retrospective review of patients diagnosed with Pierre Robin sequence who underwent mandibular distraction within the first 3 months of life was performed. Patients intubated preoperatively were excluded. RESULTS: Fifty-two patients met inclusion criteria. Thirty-eight patients (73 percent) were extubated immediately, whereas 14 patients (27 percent) remained intubated. No differences between these groups were found when comorbidities, cleft pathology, preoperative respiratory support, or grade of view on direct laryngoscopy were analyzed. Case duration greater than 120 minutes, operation start time after 3 pm, and the subjective designation of a difficult airway by the anesthesiologist were associated with maintaining intubation (p < 0.05). Eight patients (21 percent) in the extubated group required an increase in respiratory support in the postoperative interval. Four of these patients (11 percent) required reintubation. Increased postoperative respiratory support was more likely in patients with certain comorbidities and higher preoperative respiratory support requirements (p < 0.05). CONCLUSIONS: The authors' data suggest that immediate extubation following neonatal mandibular distraction is feasible in patients who are not intubated preoperatively. Careful consideration should be given to patients who require significant respiratory support preoperatively and in those with certain comorbidities. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Development of spirulina for the manufacture and oral delivery of protein therapeutics.

The use of the edible photosynthetic cyanobacterium Arthrospira platensis (spirulina) as a biomanufacturing platform has been limited by a lack of genetic tools. Here we report genetic engineering methods for stable, high-level expression of bioactive proteins in spirulina, including large-scale, indoor cultivation and downstream processing methods. Following targeted integration of exogenous genes into the spirulina chromosome (chr), encoded protein biopharmaceuticals can represent as much as 15% of total biomass, require no purification before oral delivery and are stable without refrigeration and protected during gastric transit when encapsulated within dry spirulina. Oral delivery of a spirulina-expressed antibody targeting campylobacter-a major cause of infant mortality in the developing world-prevents disease in mice, and a phase 1 clinical trial demonstrated safety for human administration. Spirulina provides an advantageous system for the manufacture of orally delivered therapeutic proteins by combining the safety of a food-based production host with the accessible genetic manipulation and high productivity of microbial platforms.

Expanded Analysis of a Modified Enhanced Recovery Protocol in Cleft Palatoplasty.

OBJECTIVE: We have previously shown the efficacy of an enhanced recovery after surgery (ERAS) protocol in pediatric cleft palatoplasty for proof of concept (POC). We sought to validate the efficacy of ERAS when expanded to patients of variable age and complexity undergoing primary palatoplasty. MAIN OUTCOME MEASURE(S): Between April 2017 and December 2018, 100 patients were collected prospectively for the expanded assessment (ERAS2) and POC (ERAS1) and compared to historical controls both independently and in aggregate (ERAS(T)). We compared patient demographics, perioperative narcotic administration, length of stay (LOS), and rates of return to service (RTS). RESULTS: Despite increased complexity, total narcotic usage (morphine equivalents normalized per weight) during each phase of care was significantly greater in controls when compared to ERAS1, ERAS2, or ERAST, respectively (intraoperative: 0.44 mg/kg vs 0.013 mg/kg vs 0.016 mg/kg vs 0.014 mg/kg; postanesthesia care unit: 0.061 mg/kg vs 0.006 mg/kg vs 0.007 mg/kg vs 0.007 mg/kg; postoperative: 0.389 mg/kg vs 0.009 mg/kg vs 0.026 mg/kg vs 0.017 mg/kg). ERAS1 and ERAS2 groups each demonstrated a decrease in LOS (-36.6%, -26.3%) when compared to controls. Overall, application of ERAS led to a 95.7% reduction in narcotic administration and a 31.7% decrease in LOS when compared to controls. The incidence of RTS was higher in ERAS2 (13.0%) when compared to ERAS1 (2.1%) or controls (2.4%), with the strongest independent predictor being a positive perioperative respiratory viral panel (PRVP). CONCLUSIONS: Application of ERAS to palatoplasty patients of advanced age and complexity evidenced consistency with respect to decreased perioperative narcotic administration and shortened LOS. A positive PRVP was found to be an independent predictor of RTS even when ERAS was applied.

Implementation of a Modified Enhanced Recovery Protocol in Cleft Palate Repairs.

AIMS: Enhanced Recovery after Surgery (ERAS) protocols have been shown to improve patient outcomes in numerous adult surgical populations, but there are few known standards for their use in pediatric patients. To assess the effectiveness in pediatric craniofacial surgery, we present our results following the application of a modified ERAS protocol for patients undergoing primary palatoplasty. METHODS: A modified ERAS program was developed and implemented in a multidisciplinary manner. The primary components of the protocol included: (1) administration of gabapentinoids, (2) minimal perioperative narcotic use, and (3) post-operative pain control using nonnarcotic first-line agents. Fifty patients were collected prospectively, assigned to the modified ERAS protocol and compared to historic controls. We reviewed patient demographics, narcotic use, length of stay (LOS), oral intake, and complication rates. RESULTS: Between April 2017 and June 2018, 50 patients underwent palatoplasty under the modified ERAS protocol. The mean age (control: 9.7 ±â€Š2.3 months; ERAS: 9.9 ±â€Š1.6 months), weight (8.8 ±â€Š1.3 kg; 8.6 ±â€Š1.3 kg), and comorbidities did not vary between the groups. ERAS patients evidenced an increase in oral intake normalized per LOS (22.3 mL/h vs 15.4 mL/h). Total narcotic usage (morphine equivalents) during each phase of care was greater in the controls compared with ERAS (Intraop: 3.71 mg vs 0.12 mg; PACU: 0.51 mg vs 0.05 mg; Postop: 2.6 mg vs 0.07 mg). The implementation of this protocol led to a 36.6% decrease in LOS (1.83 days vs 1.16 days) without an increase in perioperative complications. CONCLUSIONS: Implementation of a modified ERAS protocol provided effective perioperative pain control allowing narcotic minimization, increased post-operative oral intake, and a shorter LOS without an increased complication rate.

Predictors of Failure in Infant Mandibular Distraction Osteogenesis.

PURPOSE: Mandibular distraction osteogenesis (MDO) has been shown to be successful in treating upper airway obstruction caused by micrognathia in pediatric patients. The purpose of this study was to assess the success rate of MDO and possible predictors of failure. PATIENTS AND METHODS: The records of all neonates and infants who underwent MDO from 2008 to 2015 were retrospectively reviewed. Procedural failure was defined as patient death or the need for tracheostomy postoperatively. Details of distraction, length of stay, and failures were captured and elucidated. RESULTS: Of the 82 patients, 47 (57.3%) were male; 46 (56.1%) had sporadic Pierre Robin sequence; 33 (40.3%) had syndromic Pierre Robin sequence; and 3 (3.7%) had micrognathia, not otherwise specified. The average distraction length was 27.5 mm (range, 15 to 30 mm; SD, 4.4 mm), the average age at operation was 63.3 days (range, 3 to 342 days; SD, 71.4 days), and the average length of post-MDO hospital stay was 43 days (range, 9 to 219 days; SD, 35 days) with an average follow-up period of 4.3 years (range, 1.1 to 9.6 years; SD, 2.6 years). There were 7 failures (8.5%) (5 tracheostomies and 2 deaths) resulting in a 91.5% success rate. Regression analysis showed that the predicted probability of the need for tracheostomy was 45% (P = .02) when the patient had a central nervous system (CNS) anomaly. The predicted probability of the need for tracheostomy and death combined was 99.6% when the patient had laryngomalacia and a CNS anomaly and was preoperatively intubated (P < .05). CONCLUSIONS: This review confirms that MDO is an effective method of treating the upper airway obstruction caused by micrognathia with a high success rate. In our sample the presence of CNS abnormalities, laryngomalacia, and preoperative intubation had a significant impact on the failure rate.

Mid-Term Dental and Nerve-Related Complications of Infant Distraction for Robin Sequence.

BACKGROUND: Mandibular distraction is effective for relieving airway obstruction in Robin sequence; however, mid-term dental and nerve-related complications have not been adequately studied. METHODS: Records were reviewed for patients with a single distraction in infancy using internal devices. Follow-up was 5 years or longer. Craniofacial dysmorphic syndromes and those affecting facial nerve function were excluded. Part I involved a review of dental records, whereas Part II involved assessment of inferior alveolar and marginal mandibular nerve function in returning patients with the use of 1,1,1,2-tetrafluoroethane cold stimulation and photography, respectively. RESULTS: Eighty-five patients met inclusion criteria. Dental records were complete in 44 patients (median follow-up, 7.3 years; range, 5.4 to 13.2 years). First permanent molar injury was seen in 42 of 88 half-mouths (48 percent); 32 of 42 (76 percent) were restorable. Primary second molar damage and ankylosis were observed in 12 of 88 (14 percent) and one of 88 half-mouths (1 percent), respectively. Mandibular second premolar absence was noted unilaterally in eight of 36 patients (22 percent) and bilaterally in six of 36 patients (17 percent). A mean 1.2 ± 0.95 operative rehabilitations were required. Nerve testing was completed in 20 patients (median follow-up, 8.7 years; range, 5.5 to 13.2 years). Complete absence of cold sensation was noted in one of 40 half-mouths (2.5 percent), whereas lower lip depressor weakness was seen in six of 40 half-mouths (15 percent). CONCLUSIONS: Infant distraction is highly successful in averting tracheostomy; however, dental and nerve-related complications remain underreported. Regular follow-up with a pediatric dentist and early recognition of injury is essential. Although inferior alveolar nerve injury appears infrequent (2.5 percent), permanent lower lip depressor weakness is more common than previously reported (15 percent of sides). CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Primary Abbe Flap for Median Cleft Lip Deformity: New Trends on an Old Concept.

OBJECTIVE: The authors present our experience using primary Abbe flaps for median cleft lip. METHODS: The records of 9 patients who underwent primary Abbe flaps were reviewed for indications, operative details, and complications. Flap design is discussed, including the "W" method to facilitate columellar reconstruction. Maxillomandibular fixation was not used. RESULTS: From 2004 to 2015, 9 patients with median cleft lip received primary Abbe flaps. Mean age was 10.2 ± 6.2 months. Lobar holoprosencephaly was confirmed by imaging in 5 of the 9 patients. Operative time averaged 70 ± 22 minutes. Flap division was performed at a mean of 3.6 ± 0.9 weeks. Patients were followed for a mean of 45 ± 49 months. No flaps were lost to vascular compromise and no dehiscences or infections were noted after initial repair. Five patients required prolonged intubation ranging from 4 to 7 days and 3 required transition to gastric feedings postoperatively. One patient with holoprosencephaly expired for reasons independent of surgery. Four patients have undergone 5 lip revisions to date. CONCLUSIONS: Patients with holoprosencephaly-spectrum disorder and median cleft lip have more favorable prognoses today. The Abbe flap may be safely and advantageously used for the primary repair of median cleft lip with extreme prolabial tissue deficiency.

Amphiphilic protein micelles for targeted in vivo imaging.

A variety of polymeric nanoparticles have been developed for bioimaging applications. This study reports on the use of a 50 nm recombinant protein nanoparticle with a multivalent surface as a vehicle for functionalization with a model imaging agent. Multiple fluorescent probes were covalently conjugated to surface amines of crosslinked amphiphilic elastin-mimetic protein micelles using N-hydroxysuccinimide ester chemistry. In vivo fluorescence imaging confirmed that protein micelles selectively accumulated at sites of angioplasty induced vessel wall injury, presumably via an enhanced permeability and retention effect. This investigation demonstrates the potential of amphiphilic protein micelles to be used as a vehicle for selective imaging of sites associated with a disrupted or leaky endothelium.

Effect of dopamine transporter genotype on caudate volume in childhood ADHD and controls.

Polymorphism of the dopamine transporter genotype (DAT1) confers a small but significant susceptibility to attention deficit hyperactivity disorder (ADHD). We examined whether the volume of the head of caudate, a striatal structure with high DAT expression that is important for inhibitory function, differs by DAT1 in children diagnosed with the disorder relative to age and IQ matched controls. Volume of the head of caudate was delineated in the right and left hemisphere and compared between 7- and 13-year-old children with and without ADHD (combined type) who were carriers of two (10/10) or one (9/10) copy of the 10-repeat DAT1 allele. Caudate volumes were overall smaller in 10/10 than 9/10 children, particularly in the left than right hemisphere. While DAT1 effects did not vary by ADHD diagnosis, overall caudate volumes were smaller in ADHD relative to control children. Altered caudate development associated with 10-repeat homozygosity of DAT1 may contribute susceptibility to ADHD.