Cardio-Obstetrics Team-Based Management of a Pregnant Patient With Severe Bioprosthetic Aortic Valve Disease.

A 38-year-old pregnant patient was managed by the cardio-obstetrics multidisciplinary team for severe degenerative bioprosthetic aortic valve failure. She was medically managed utilizing echocardiogram and brain natriuretic peptide until she demonstrated worsening heart failure. A valve and cardio-obstetrics team evaluation led to valve-in-valve transcatheter aortic valve replacement at 30 weeks' gestation.

Convolutional Neural Network Models for Automatic Preoperative Severity Assessment in Unilateral Cleft Lip.

BACKGROUND: Despite the wide range of cleft lip morphology, consistent scales to categorize preoperative severity do not exist. Machine learning has been used to increase accuracy and efficiency in detection and rating of multiple conditions, yet it has not been applied to cleft disease. The authors tested a machine learning approach to automatically detect and measure facial landmarks and assign severity grades using preoperative photographs. METHODS: Preoperative images were collected from 800 unilateral cleft lip patients, manually annotated for cleft-specific landmarks, and rated using a previously validated severity scale by eight expert reviewers. Five convolutional neural network models were trained for landmark detection and severity grade assignment. Mean squared error loss and Pearson correlation coefficient for cleft width ratio, nostril width ratio, and severity grade assignment were calculated. RESULTS: All five models performed well in landmark detection and severity grade assignment, with the largest and most complex model, Residual Network, performing best (mean squared error, 24.41; cleft width ratio correlation, 0.943; nostril width ratio correlation, 0.879; severity correlation, 0.892). The mobile device-compatible network, MobileNet, also showed a high degree of accuracy (mean squared error, 36.66; cleft width ratio correlation, 0.901; nostril width ratio correlation, 0.705; severity correlation, 0.860). CONCLUSIONS: Machine learning models demonstrate the ability to accurately measure facial features and assign severity grades according to validated scales. Such models hold promise for the creation of a simple, automated approach to classifying cleft lip morphology. Further potential exists for a mobile telephone-based application to provide real-time feedback to improve clinical decision making and patient counseling.

Rationale and design of an evidence-based tool to guide preoperative evaluation and management.

BACKGROUND: In the United States, over-testing and over-treatment are recognised causes of excess cost and patient harm. Healthcare value, defined as health outcomes achieved relative to the costs of care, has become a focus to improve the quality and affordability of healthcare. AIM: To describe the rationale for, and development of a standardised clinical preoperative decision-support tool.Program description: An evidence-based, preoperative clinical decision tool was developed to guide preoperative testing and management of high-risk medications.Program evaluation: Patient data before and after implementation of the tool will be analysed to determine its effectiveness in reducing preoperative testing. DISCUSSION: Preoperative testing is an area that presents an opportunity to increase healthcare value and decrease healthcare spending. Guidelines are available to standardise preoperative assessment but their adoption and acceptance into practice has been slow. To systematise preoperative assessment within our healthcare system, we reviewed current published literature and guidelines and synthesised them into an electronic, evidence-based, decision-support tool. After distribution of the tool to clinicians in our healthcare system, we will assess its impact on healthcare value, costs and outcomes. We believe that an evidence-based preoperative tool, seamlessly and efficiently integrated into clinician workflow, can improve preoperative patient care.

Ventricular Septal Rupture Complicating Delayed Acute Myocardial Infarction Presentation During the COVID-19 Pandemic.

The rate of mechanical complications of acute myocardial infarction has declined. Recent publications raised concerns over the reduction in cardiac catheterization laboratory activation for ST-segment myocardial infarction (STEMI) during the coronavirus disease-2019 (COVID-19) pandemic. We present 2 recent cases of ventricular septal rupture in patients who presented to our institution with delayed STEMI. (Level of Difficulty: Intermediate.).

Patient Satisfaction with Medical Tourism: A Review of 460 International Plastic Surgery Patients in Colombia.

Cosmetic surgery is at the forefront of an exploding medical tourism industry. Patients are able to research options globally through the internet, and increasing numbers are seeking improved service, quality, and value through surgery overseas. Little work has been done to measure the patient experience when traveling for surgery and, to our knowledge, this is the largest study of its kind to examine patient satisfaction with medical tourism. METHODS: We retrospectively reviewed patient satisfaction surveys completed by 460 consecutive international patients receiving cosmetic surgery at a private plastic surgery practice in Cartagena, Colombia, between February 2016 and April 2018. RESULTS: Overall patient satisfaction was excellent, with 98.2% responding that they would refer us to friends and family. Patient satisfaction ratings across all other items was also very high (range: 97.1%-100%) for information provided, the surgeon, the staff, facilities, and payment. CONCLUSIONS: Excellent patient satisfaction is possible with medical tourism if the patient perceives and receives value through effective results, a pleasant experience, and favorable costs. These successes in plastic surgery medical tourism highlight the potential for significant continued growth in this sector as a whole.

The cost of electric-scooter related orthopaedic surgery.

AIM: To highlight the growing cost of electric-scooter (e-scooter) related injuries necessitating surgical intervention by the Auckland City Hospital Orthopaedic Department. METHODS: Retrospective audit of operations by the Auckland City Hospital Orthopaedic Department from 15 October 2018 up to and inclusive of 22 February 2019. Inclusion criteria was that the direct cause of injury necessitating surgery was secondary to an e-scooter accident. Further demographic data was collected including injury sustained and operation details. The surgical costs were calculated, including anaesthetic time, surgical time, staffing, implants used and inpatient stay as well as clinic follow-up. RESULTS: Over the 19-week period of this study there were 21 patients requiring 23 operations as a direct result of e-scooters. The summative anaesthetic, theatre suite and staffing costs of these operations was $162,901. Implants required to fix the fractures totalled $39,898. Ninety-three inpatient nights and 61 follow-up clinic appointments were required incurring an additional expense of $141,639 and $16,119 respectively. Overall, these 23 cases cost a total of $360,557. The extrapolated loss of income was $44,368 secondary to these injuries. This represents a total economic cost of $404,925, or $19,282 per person. CONCLUSION: This study highlights that there can be serious consequences of e-scooter travel. High energy trauma not previously associated with scooter injuries is becoming increasingly prevalent as a result of readily available e-scooters. Many of the injuries identified represent significant morbidity to patients in terms of pain, lengthy rehabilitation and loss of income. Furthermore, the socioeconomic costs for DHBs continues to climb and adds to the acute surgical burden in an already busy healthcare system. The hazards of e-scooters should not be underestimated by both the general public and policy-makers.

Activity of imipenem/relebactam against carbapenemase-producing Enterobacteriaceae with high colistin resistance.

OBJECTIVES: Imipenem/relebactam, an investigational ß-lactam/ß-lactamase inhibitor combination for treatment of Gram-negative infections, and comparators including ceftazidime/avibactam, piperacillin/tazobactam and colistin were tested for activity against representative carbapenemase-producing Enterobacteriaceae (CPE) isolates. METHODS: MICs of the antimicrobial agents were determined using standard broth microdilution methodology for CPE isolates collected from Indiana patients, primarily during the time frame of 2013-17 (n = 199 of a total of 200 isolates). Inhibitors were tested at 4 mg/L in all combinations. RESULTS: Of the CPE in the study, 199 produced plasmid-encoded KPC class A carbapenemases; 1 Serratia marcescens isolate produced the SME-1 chromosomal class A carbapenemase. MIC50/MIC90 values of imipenem/relebactam were ≤0.25/0.5 mg/L, whereas MIC50/MIC90 values of ceftazidime/avibactam were 1/2 mg/L. Resistance to colistin was observed in 54% (n = 97) of 180 non-Serratia isolates tested (MIC50 of 4 mg/L). Colistin resistance mechanisms included production of a plasmid-encoded mcr-1-like gene (n = 2) or an inactivated mgrB gene. CONCLUSIONS: Imipenem/relebactam was the most potent agent tested against CPE in this study and may be a useful addition to the antimicrobial armamentarium to treat infections caused by these pathogens.

Influence of Severity on Aesthetic Outcomes of Unilateral Cleft Lip Repair in 1,823 Patients.

BACKGROUND: Although efforts to improve access to care for patients with cleft lip in the developing world have grown tremendously, there is a dearth of data regarding aesthetic outcomes after cleft lip repairs in this setting. Defining severity-outcome relationships has the potential to improve efficiency of care delivery in resource-limited settings, and to improve overall results. In this study, we investigate the relationship between initial cleft lip severity and early aesthetic outcomes following surgical repair of primary unilateral cleft lip. METHODS: Using previously validated tools to assess unilateral cleft lip severity and aesthetic outcome after repair, we evaluated 1,823 consecutive patients who underwent primary unilateral cleft lip/nose (UCL/N) repair. Three separate evaluators scored each case for a total of 5,469 total independent evaluations. RESULTS: Our results show that with increasing severity of UCL/N deformity, there is a corresponding decrease in early aesthetic outcome scores. Using our results, we established normative early aesthetic outcomes following repair for each severity grade of UCL/N deformity. CONCLUSIONS: In conclusion, this study has achieved a standardized, timely, and cost-effective evaluation of 1,823 surgical cases of primary UCL/N repair. This data set provides a normal distribution of aesthetic results according to initial cleft severity and defines a standard of "expected" aesthetic results after primary UCL/N repair. Our results also show a clear correlation between initial severity and immediate aesthetic result after surgery, though we also show that excellent results are possible regardless of initial cleft severity.

Resource utilization and outcome among patients with selective versus nonselective troponin testing.

OBJECTIVE: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. Troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for resource utilization and outcome. Therefore, we examined selective versus nonselective troponin testing with respect to patient characteristics, resource utilization, and outcome. METHODS: This retrospective 1-year study included all patients with troponin testing at a U.S. emergency department. Testing was classified as selective (ACS) or nonselective (non-ACS) based on admission ICD-9 codes. Troponin upper reference limit (URL) was ≥99th percentile. RESULTS: Among 47,053 patients, troponin was measured in 9109 (19%) of whom 5764 were hospitalized. Admission diagnosis was non-ACS in 4427 (77%) and ACS in 1337 (23%). Non-ACS patients were older, 71±17 versus 65±16 years, with longer hospital stay, 77 versus 32 h, and greater 1-year mortality 22% versus 6.7%; P<.001. In patients with troponin ≥URL, revascularization was performed in 64 (4.7%) of non-ACS versus 213 (48%) of ACS; P<.001. In patients with troponin 80% of the non-ACS population CONCLUSIONS: Contemporary troponin testing is frequently nonselective. The non-ACS and ACS populations differ significantly regarding clinical characteristics, revascularization rates, and outcomes. Troponin elevation is a powerful predictor of 1-year mortality in non-ACS, this association reveals an opportunity for risk stratification and targeted therapy. KEY QUESTIONS: In patients with suspected acute coronary syndrome (ACS), troponin testing is effective for diagnosis and prognosis. However, troponin testing has now expanded to include patients without suspected ACS. This nonselective troponin testing has unknown consequences for hospital resource utilization and patient outcome. Our findings demonstrate contemporary troponin testing is largely nonselective (77% of testing was performed in patients without acute coronary syndrome). In comparison to patients with acute coronary syndrome, those with non-acute coronary syndrome are older, with longer hospital stay, lower revascularization rates, and greater 1-year mortality. Troponin elevation identifies a high-risk population in both acute coronary syndrome and non-acute coronary syndrome populations, yet effective treatment for the latter is lacking.

Improved Early Cleft Lip and Palate Complications at a Surgery Specialty Center in the Developing World.

OBJECTIVE: To evaluate complication rates following cleft lip and cleft palate repairs during the transition from mission-based care to center-based care in a developing region. PATIENTS AND DESIGN: We performed a retrospective review of 3419 patients who underwent cleft lip repair and 1728 patients who underwent cleft palate repair in Guwahati, India between December 2010 and February 2014. Of those who underwent cleft lip repair, 654 were treated during a surgical mission and 2765 were treated at a permanent center. Of those who underwent cleft palate repair, 236 were treated during a surgical mission and 1491 were treated at a permanent center. SETTING: Two large surgical missions to Guwahati, India, and the Guwahati Comprehensive Cleft Care Center (GCCCC) in Assam, India. MAIN OUTCOME MEASURE: Overall complication rates following cleft lip and cleft palate repair. RESULTS: Overall complication rates following cleft lip repair were 13.2% for the first mission, 6.7% for the second mission, and 4.0% at GCCCC. Overall complication rates following cleft palate repair were 28.0% for the first mission, 30.0% for the second mission, and 15.8% at GCCCC. Complication rates following cleft palate repair by the subset of surgeons permanently based at GCCCC (7.2%) were lower than visiting surgeons ( P < .05). CONCLUSIONS: Our findings support the notion that transitioning from a mission-based model to a permanent facility-based model of cleft care delivery in the developing world can lead to decreased complication rates.

Competency-Based Education in Low Resource Settings: Development of a Novel Surgical Training Program.

BACKGROUND: The unmet burden of surgical disease represents a major global health concern, and a lack of trained providers is a critical component of the inadequacy of surgical care worldwide. Competency-based training has been advanced in high-income countries, improving technical skills and decreasing training time, but it is poorly understood how this model might be applied to low- and middle-income countries. We describe the development of a competency-based program to accelerate specialty training of in-country providers in cleft surgery techniques. METHODS: The program was designed and piloted among eight trainees at five international cleft lip and palate surgical mission sites in Latin America and Africa. A competency-based evaluation form, designed for the program, was utilized to grade general technical and procedure-specific competencies, and pre- and post-training scores were analyzed using a paired t test. RESULTS: Trainees demonstrated improvement in average procedure-specific competency scores for both lip repairs (60.4-71.0%, p < 0.01) and palate (50.6-66.0%, p < 0.01). General technical competency scores also improved (63.6-72.0%, p < 0.01). Among the procedural competencies assessed, surgical markings showed the greatest improvement (19.0 and 22.8% for lip and palate, respectively), followed by nasal floor/mucosal approximation (15.0%) and hard palate dissection (17.1%). CONCLUSION: Surgical delivery models in LMICs are varied, and trade-offs often exist between goals of case throughput, quality and training. Pilot program results show that procedure-specific and general technical competencies can be improved over a relatively short time and demonstrate the feasibility of incorporating such a training program into surgical outreach missions.

Validation of a Unilateral Cleft Lip Surgical Outcomes Evaluation Scale for Surgeons and Laypersons.

BACKGROUND: A standardized evaluation tool is needed for the assessment of surgical outcomes in cleft lip surgery. Current scales for evaluating unilateral cleft lip/nose (UCL/N) aesthetic outcomes are limited in their reliability, ease of use, and application. The Unilateral Cleft Lip Surgical Outcomes Evaluation (UCL SOE) scale measures symmetry of 4 components and sums these for a total score. The purpose of this study was to validate the SOE as a reliable tool for use by both surgeons and laypersons. METHODS: Twenty participants (9 surgeons and 12 laypeople) used the SOE to evaluate 25 sets of randomly selected presurgical and postsurgical standardized photographs of UCL/N patients. Interrater reliability for surgeon and laypeople was determined using an intraclass correlation coefficient (ICC). RESULTS: Individual surgeons and laypeople both reached an ICC in the "fair to good" range (ICC = 0.42 and 0.59, respectively). Averaging 2 evaluators in the surgeon group improved the ICC to 0.58 and in the laypeople group to 0.74, respectively. Averaging 3 evaluators increased the ICC for surgeons to the "good" range (ICC = 0.71) and the ICC for laypeople to the "very good" range (ICC = 0.82). CONCLUSIONS: Surgeon and layperson raters can reliably use the SOE to assess the aesthetics results after surgical repair of UCL/N, and improved reliability and reproducibility is achieved by averaging the scores of multiple reviewers.

Validation of the Unilateral Cleft Lip Severity Index for Surgeons and Laypersons.

BACKGROUND: Severity of the primary unilateral cleft lip/nose deformity (UCL/N) is postulated to play a key role in postoperative complications, aesthetic result, and need for secondary surgery. There is no validated and widely accepted classification scheme of initial cleft severity. The purpose of this study was to validate the Unilateral Cleft Lip Cleft Severity Index as a reliable tool for evaluating presurgical UCL/N deformity by both surgeons and laypersons. METHODS: Twenty-five participants (10 surgeons and 15 laypeople) evaluated 25 sets of randomly selected presurgical standardized photographs of UCL/N patients. Each participant rated patients on a scale of 1-4 using the Cleft Severity Index. Interrater reliability for surgeons, laypersons, and all participants was determined using an intraclass correlation coefficient. Histograms and regression analysis were performed to compare average ratings between groups. RESULTS: Interrater reliability for all groups was classified as "very good" determined by intraclass correlation coefficients of 0.837 (laymen), 0.885 (surgeons), and 0.848 (all participants). These results indicate that there was a high degree of interrater across all 3 groups and that both surgeons and laypersons can reliability rate cleft severity using the Cleft Severity Index. CONCLUSIONS: This study validates the use of the Cleft Severity Index by both surgeons and laypersons as a reliable tool for evaluating the degree of presurgical severity of patients with UCL/N. The Unilateral Cleft Lip Cleft Severity Index can thus serve as a reproducible and reliable grading system for primary UCL/N deformity and to categorize patients for future outcomes studies.

Toxicity from fluoropolymer-containing grout, tile and stone floor sealants reported to the UK National Poisons Information Service 2009-2015.

CONTEXT: Grout, tile and floor stone sealants contain a solvent, a water-repelling agent and in the case of aerosols a propellant. The water-repelling agent used is typically a fluoropolymer resin, a silicon-based resin, or a combination of both. OBJECTIVE: To report the clinical course in patients exposed to fluoropolymer-containing sealants referred to the United Kingdom National Poisons Information Service. METHODS: A retrospective analysis was performed of telephone enquiries received between 2009 and 2015. RESULTS: 101 enquiries involving 96 exposures were received. The majority of the exposures (n = 88) occurred when the sealant was delivered from an aerosol. Twelve patients were exposed occupationally and the remainder were exposed while using the product at home. Eighty-nine exposures were as a result of inhalation alone, two followed ingestion, three skin contact and one eye contact; one involved inhalation and eye contact. All 90 patients exposed by inhalation developed clinical features: 31 had a World Health Organisation/International Programme on Chemical Safety/European Commission/European Association of Poison Centres and Clinical Toxicologists Poisoning Severity Score of 1 (minor toxicity), 51 patients had features of moderate toxicity (PSS 2) and eight were graded PSS 3 (severe poisoning). The most common features were dyspnea (n = 52; 57.8%; 95% CI = 47.0-68.5), chest pain/tightness (n = 34; 37.8%; 95% CI = 27.2-48.4), coughing (n = 27; 30.0%; 95% CI = 20.0-40.0) and sinus tachycardia (n = 11; 12.2%; 95% CI = 4.1-18.2); hypoxemia was present in 20 (22.2%; 95% CI = 13.1-31.4). At the time of the enquiry a chest X-ray had been performed on 15 patients: in eight patients (all of whom were PSS 3) the X-ray was reported as being abnormal and showed bilateral shadowing. CONCLUSIONS: This study demonstrates that if fluoropolymer-containing sealants are inhaled then clinical features may occur and in a small proportion (9%) these features may be severe.

Primary Cleft Lip and Palate Repair in Assam, India: Does Preoperative Anthropometric Analysis Help Identify Patients With Increased Surgical Risk in a Clinically Prescreened Population?

OBJECTIVE: To compare anthropometric z-scores with incidence of post-operative complications for patients undergoing primary cleft lip or palate repair. DESIGN: This was a retrospective observational analysis of patients from a surgical center in Assam, India, and includes a cohort from a single surgical mission completed before the opening of the center. SETTING: Patients included in the study underwent surgery during an Operation Smile mission before the opening of Operation Smile's Guwahati Comprehensive Cleft Care Center in Guwahati, India. The remaining cohort received treatment at the center. All patients received preoperative assessment and screening; surgery; and postoperative care, education, and follow-up. PATIENTS, PARTICIPANTS: Our sample size included 1941 patients and consisted of all patients with complete information in the database who returned for follow-up after receiving primary cleft lip repair or primary cleft palate repair between January 2011 and April 2013. INTERVENTIONS: Preoperative anthropometric measurements. MAIN OUTCOME MEASURE(S): Postoperative complications. RESULTS: Anthropometric z-scores were not a significant predictor of adverse surgical outcomes in the group analyzed. Palate surgery had increased risk of complication versus lip repair, with an overall odds ratio of 5.66 (P < .001) for all patients aged 3 to 228 months. CONCLUSIONS: Anthropometric z-scores were not correlated with increased risk of surgical complications, possibly because patients were well screened for malnutrition before surgery at this center. Primary palate repair is associated with an approximate fivefold increased risk of developing postoperative complication(s) compared with primary lip repair.

The Medical Mission and Modern Core Competency Training: A 10-Year Follow-Up of Resident Experiences in Global Plastic Surgery.

BACKGROUND: The emphasis on cultural competency for physicians and surgeons is increasingly important, as communication with both patients and other providers significantly affects individual and system-wide outcomes. International surgical training has been shown to improve leadership skills, cultural competency, and technical proficiency of participants in short-term follow-up. This study explores the long-term impact of international surgical mission experiences on developing participants' core competencies, professional outcomes, and commitment to global health. METHODS: All 208 plastic and reconstructive surgeons who completed the Operation Smile Regan/Stryker fellowship programs between 2006 and 2015 were surveyed electronically. RESULTS: One hundred sixty-five surveys were returned, for an overall response rate of 79.3 percent. The majority of participants reported that the fellowship positively impacted all six Accreditation Council for Graduate Medical Education core competencies. Most participants who were attending physicians at the time of the survey were practicing general plastic surgery, with 42 percent in an academic/teaching environment, 32 percent in assistant/associate professor positions, and 6 percent in either a program director or department chairman position. The majority currently volunteer on local or international missions, and all respondents would consider volunteering again. CONCLUSIONS: Carefully structured and rigorously proctored programs such as the Regan/Stryker Fellowship offer plastic surgery residents the opportunity to gain valuable professional and personal experiences that benefit them long after their service experience. Programs of this nature can not only effectively improve cultural competency of physicians, but also positively influence their attitudes toward leadership and direct that potential to meet the growing need for surgical care in low- and middle-income countries.

Engineering of a Nepetalactol-Producing Platform Strain of Saccharomyces cerevisiae for the Production of Plant Seco-Iridoids.

The monoterpene indole alkaloids (MIAs) are a valuable family of chemicals that include the anticancer drugs vinblastine and vincristine. These compounds are of global significance-appearing on the World Health Organization's list of model essential medicines-but remain exorbitantly priced due to low in planta levels. Chemical synthesis and genetic manipulation of MIA producing plants such as Catharanthus roseus have so far failed to find a solution to this problem. Synthetic biology holds a potential answer, by building the pathway into more tractable organisms such as Saccharomyces cerevisiae. Recent work has taken the first steps in this direction by producing small amounts of the intermediate strictosidine in yeast. In order to help improve on these titers, we aimed to optimize the early biosynthetic steps of the MIA pathway to the metabolite nepetalactol. We combined a number of strategies to create a base strain producing 11.4 mg/L of the precursor geraniol. We also show production of the critical intermediate 10-hydroxygeraniol and demonstrate nepetalactol production in vitro. Lastly we demonstrate that activity of the iridoid synthase toward the intermediates geraniol and 10-hydroxygeraniol results in the synthesis of the nonproductive intermediates citronellol and 10-hydroxycitronellol. This discovery has serious implications for the reconstruction of the MIA in heterologous organisms.

Surgical Complications in 1408 Primary Cleft Palate Repairs Operated at a Single Center in Guwahati, Assam, India.

OBJECTIVE: To analyze surgical complications after primary cleft palate repair in a setting with limited resources. PATIENTS AND DESIGN: A total of 1608 consecutive cleft palate repairs with 1408 follow-ups, operated upon between 2011 and 2013, were reviewed retrospectively through medical records. Patients were 10 months to 50 years old at the time of surgery, with a median age of 9 years. SETTING: Guwahati Comprehensive Cleft Care Center, Guwahati, India. INTERVENTION: Primary cleft palate repair. MAIN OUTCOME MEASURES: Postoperative complications in terms of necrosis, dehiscence, fistula, infection, and "hanging palate" were assessed, as was perioperative bleeding. Logistic regression was used with complication (yes/no) as the binary dependent variable and with age, cleft type, and surgeon (visiting/long-term) as covariates. RESULTS: The overall incidence of postoperative complications was 16.9% with a fistula rate of 13.6%. The incidence of perioperative bleeding was 1.8%. Logistic regression analysis identified cleft severity (P ≤ .001) and visiting surgeon (P ≤ .01) as factors related to the incidence of postoperative complications. Age at surgery was related to both the incidence of postoperative complications (P ≤ .001) and perioperative bleeding (P < .05). CONCLUSION: Due to increased risks of surgical complications, older patients with complete clefts should only be operated upon after careful consideration. In addition, these patients should be assigned to surgeons experienced with this cleft type.

Role of Postoperative Antimicrobials in Cleft Palate Surgery: Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Study in India.

BACKGROUND: The purpose of this study was to determine whether administration of postoperative antibiotics affects the incidence of complications after primary cleft palate repair in a developing area. METHODS: This study was a prospective, double-blind, randomized, placebo-controlled trial composed of 518 consecutive patients who underwent primary cleft palate repair at a single institution. Patients were aged 1 to 43 years at the time of surgery (median, 9 years). The patients were divided randomly into two groups. One group received a 5-day regimen of oral amoxicillin (50 mg/kg/day) postoperatively and the other group received placebo medication. Both groups received a single dose of cefuroxime (30 mg/kg) before incision. Patients and providers were blinded to the randomization. Patients were followed postoperatively for early complications (infection and wound breakdown) and for late complications (palatal fistulas). RESULTS: The incidence of early complications was 13.8 percent among the patients in the placebo group and 8.7 percent among the patients in the antibiotic group (p = 0.175). Fistulas were noted in 17.1 percent in the placebo group and in 10.7 percent in the antibiotic group (p = 0.085). Logistic regression analysis identified visiting surgeons as the only covariate related to early complications (OR, 3.71; p < 0.001). However, the use of placebo (OR, 2.09; p = 0.037), female sex (OR, 2.04; p = 0.047), and Veau III and IV (OR, 3.31; p = 0.004) were observed as factors associated with the incidence of fistulas. CONCLUSION: The authors' results indicate that postoperative antibiotic prophylaxis can reduce the incidence of fistulas after primary cleft palate repair in a developing area.