bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Novel Absorbable Stapler Provides Patient-Reported Outcomes and Cost-Effectiveness Noninferior to Subcuticular Skin Closure: A Prospective, Single-Blind, Randomized Clinical Trial
Authors: Malard Olivier , Duteille Franck , Darnis Eric , Espitalier Florent , Perrot Pierre , Ferron Christophe , Planche Lucie , Hardouin Jean-Benoit , Tessier Philippe , Bellanger Martine , Dert Cécile 
Published: September 2020

Background:
Deep dermal suturing is critical for scar quality outcomes. The authors evaluated a new, fast medical device for dermal suturing, with the hypothesis of noninferiority with regard to clinical scar and cost-effectiveness.

Methods:
A prospective, patient-blind, randomized, multicenter noninferiority study in 26 French hospitals was conducted. Patients were randomized 1:1 to suturing with conventional thread or a semiautomatic stapler. The Patient Scar Assessment Scale was rated at 3 months for primary endpoint effectiveness. Secondary endpoints were cost-effectiveness of the two suturing methods, prevalence of complications, suturing/operating time, Observer Scar Assessment Scale and Patient Scar Assessment Scale score, scar aesthetic quality 18 months after surgery, and occupational exposure to blood during surgery.

Results:
Six hundred sixty-four patients were enrolled, 660 were randomized, and 649 constituted the full analysis (stapler arm, n = 324; needle arm, n = 325). Primary endpoint Patient Scar Assessment Scale score in the stapler arm was not inferior to that in the needle arm at 3 months or after 18 months. The mean operating time was 180 minutes in the stapler arm and 179 minutes in the needle arm (p = not significant). The mean suturing time was significantly lower in the stapler arm (p < 0.001). There were seven occupational exposures to blood in the needle arm and one in the stapler arm. The two arms did not differ significantly in terms of complications (p = 0.41). The additional cost of using the device was €51.57 for the complete-case population.

Conclusion:
Wound healing outcome was no worse than with conventional suturing using a semiautomatic stapler and associated with less occupational exposure to blood.

CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, I.
Incidence of Major Arterial Abnormality in Patients with Wound Dehiscence after Lower Extremity Orthopedic Procedures
Authors: Zolper Elizabeth G. , Kotha Vikas S. , Walters Elliot T. , Nigam Manas , Lakhiani Chrisovalantis X. , Fortman Emilie C. , Janhofer David E. , Steinberg John S. , Attinger Christopher E. , Evans Karen K. 
Published: September 2020

Background:
Surgical dehiscence can occur after lower extremity orthopedic procedures. Underlying vascular aberrancy and localized ischemia contribute to chronic wound development requiring advanced techniques such as free tissue transfer. Localized vascular abnormality is an underrecognized contributing factor to such dehiscence. The authors reviewed their lower extremity free tissue transfer experience in this population to analyze the incidence of arterial abnormality and outcomes.

Methods:
The authors conducted a retrospective review of 64 lower extremity free tissue transfers performed for chronic wounds after orthopedic procedures from 2011 to 2018. The primary outcome was major arterial abnormality as identified on angiography. Secondary outcomes were flap success, limb salvage, and ambulation status.

Results:
The median age was 58 years, and 44 were men (69 percent). Comorbidities included osteomyelitis (77 percent), diabetes (39 percent), and peripheral vascular disease (17 percent). The incidence of arterial abnormality on angiography was 47 percent. Defect location correlated with angiosome of arterial abnormality in 53 percent. The flap success rate was 92 percent. Limb salvage and ambulation rates were 89 and 89 percent, respectively, at an average follow-up of 17.6 months. Men demonstrated an increased rate of limb salvage (p = 0.026). Diabetes (p = 0.012), arterial abnormality (p = 0.044), and arterial flap complication (p = 0.010) correlated with amputation.

Conclusions:
The high incidence of arterial abnormality in this population highlights the importance of expedient multidisciplinary care, including vascular and plastic surgery. Diagnostic angiography is important for identifying major arterial abnormality and the need for free tissue transfer for definitive coverage.
Osseointegration of Extremity Prostheses: A Primer for the Plastic Surgeon
Authors: Souza Jason M. , Mioton Lauren M. , Harrington Colin J. , Potter Benjamin K. , Forsberg Jonathan A. 
Published: September 2020

Summary:
Interest in amputation surgery has increased in conjunction with rising public awareness about amputee care. To date, plastic surgeons have impacted the quality of life and functional potential of amputees through novel strategies for sensory feedback and prosthesis control and various techniques for neuroma treatment and prevention. Osseointegration, which involves the direct skeletal attachment of a prosthesis to bone, has the ability to further maximize amputee function. There exists a critical role for plastic surgeons to help optimize techniques for extremity osseointegration through improved wound care and soft-tissue management. An overview of current osseointegrated prostheses and their associated limitations, and potential avenues through which plastic surgeons can help mitigate these challenges, are discussed in this article.
Diffuse Venous Malformations of the Upper Extremity (Bockenheimer Disease): Diagnosis and Management
Authors: Ali Barkat , Panossian Andre , Taghinia Amir , Mulliken John B. , Alomari Ahmad , Adams Denise M. , Fishman Stephen J. , Upton Joseph 
Published: September 2020

Background:
Diffuse venous malformations that involve all tissues in the upper limb and ipsilateral chest wall are known as “phlebectasia of Bockenheimer.” The authors describe their experience with management of this uncommon vascular anomaly.

Methods:
The authors’ Vascular Anomalies Center registry comprised 18,766 patients over a 40-year period. This review identified 2036 patients with venous malformations of the extremities (10.8 percent), of whom only 80 (0.43 percent) had Bockenheimer disease. The authors retrospectively analyzed patient characteristics, diagnostics, treatments, and complications.

Results:
The venous malformation was first noted at birth or within the first few years of life with slow and gradual progression. Pain was related to engorgement of the limb. Thromboses and phleboliths were common, but diffuse intravascular coagulopathy occurred in only 12 patients (15 percent). Skeletal involvement was demonstrated as lytic lesions, cortical scalloping, osteopenia, and pathologic fractures. Management included compression garments (100 percent), sclerotherapy (27.5 percent), and resection of symptomatic areas in 35 percent of patients. Adjunctive pharmacologic medication was given in 7.5 percent. Following resection, 17 patients (60 percent) had one or more complications: hematoma, wound dehiscence, flap loss, contracture, and psychosis. There were no deaths. Symptoms improved in all patients with useful functional outcomes.

Conclusions:
The decision to pursue compression, sclerotherapy, pharmacologic treatment, or resection alone or in combination was made by an interdisciplinary team. Although extensive venous malformations cannot be completely ablated, debulking of symptomatic regions, resection of neuromas, and noninvasive treatments improve the quality of life. Despite the bulk and weight of the arm, forearm, and hand, and the ominous appearance on magnetic resonance imaging, these patients remain functional.

CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, V.
Three-Dimensional Facial Scanning at the Fingertips of Patients and Surgeons: Accuracy and Precision Testing of iPhone X Three-Dimensional Scanner
Authors: Rudy Hayeem L. , Wake Nicole , Yee Judy , Garfein Evan S. , Tepper Oren M. 
Published: September 2020

Background:
The iPhone X (Apple, Inc., Cupertino, Calif.) is the first smartphone to be released with a high-fidelity three-dimensional scanner. At present, half of all U.S. smartphone users use an iPhone. Recent data suggest that the majority of these 230 million individuals will upgrade to the iPhone X within 2 years. This represents a profound expansion in access to three-dimensional scanning technology, not only for plastic surgeons but for their patients as well. The purpose of this study was to compare the iPhone X scanner against a popular, portable three-dimensional camera used in plastic surgery (Canfield Vectra H1; Canfield Scientific, Inc., Parsippany, N.J.).

Methods:
Sixteen human subjects underwent three-dimensional facial capture with the iPhone X and Canfield Vectra H1. Results were compared using color map analysis and surface distances between key anatomical landmarks. To assess repeatability and precision of the iPhone X three-dimensional scanner, six facial scans of a single participant were obtained and compared using color map analysis. In addition, three-dimensionally–printed facial masks (n = 3) were captured with each device and compared.

Results:
For the experiments, average root mean square was 0.44 mm following color map analysis and 0.46 mm for surface distance between anatomical landmarks. For repeatability and precision testing, average root mean square difference following color map analysis was 0.35 mm. For the three-dimensionally–printed facial mask comparison, average root mean square difference was 0.28 mm.

Conclusions:
The iPhone X offers three-dimensional scanning that is accurate and precise to within 0.5 mm when compared to a commonly used, validated, and expensive three-dimensional camera. This represents a significant reduction in the barrier to access to three-dimensional scanning technology for both patients and surgeons.
40 Years of Total Extracorporeal Septal Reconstruction: The Past, Present, and Future
Authors: Gubisch Wolfgang , Hacker Stefan , Neumann Jens , Haack Sebastian 
Published: September 2020

Background:
Even today, severe septal deformities are a challenging problem for any rhinoplasty surgeon. Standard techniques are often not able to achieve satisfactory long-term results regarding function or aesthetic form. In such severe cases, a partial or total extracorporeal septal reconstruction may be used, as these techniques provide reliable and lasting results.

Methods:
The aim of this work is to present the authors’ experience with the technique of total extracorporeal septal reconstruction and its development to today’s standard and to prove its effectiveness in the long-term follow-up.

Results:
This article presents 40 years of clinical experience in this field and describes the technical changes that have evolved. Low complication rates, safe techniques, and favorable long-term outcomes of the total extracorporeal septal reconstruction show the benefits of this technique.

Conclusion:
The indication for a total extracorporeal septal reconstruction has been limited by the development of less complex surgical procedures, but it still represents the best technique to achieve long-term functional and aesthetic results in patients with very complex septal deformities.

CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, V.
Routine Bedside Use of Obstetric Early Warning System in the Postnatal Ward to Identify Maternal Morbidity Among High-Risk Women
Authors: Hoppu Sanna , Hannola Katja , Mennander Susanna , Huhtala Heini , Rissanen Maria , Tulensalo Eveliina , Laivuori Hannele , Tihtonen Kati 
Published: September 2020

Objective
Several authorities have recommended the use of an obstetric early warning system (OEWS) to prevent severe morbidity and mortality. Data on the accuracy of OEWS in different clinical settings and maternal populations are still scarce. Our aim was to validate OEWS to detect maternal morbidity among high-risk women in the postnatal ward.

Methods
An OEWS was assigned to women with a body mass index >35 kg/m2, postpartum hemorrhage (PPH) >1500 mL, preeclampsia, concern over the maternal condition, chorioamnionitis, or type 1 diabetes. Morbidity was defined as worsening preeclampsia, action on hemorrhage, thromboembolia, diabetic ketoacidosis, puerperal infections, transfer to the intensive care unit, cardiopulmonary dysfunction, or death during the stay in the postnatal ward. The use of OEWS was implemented on November 1, 2016, and the study period ended on April 30, 2018.

Results
The study group included 827 women. The incidence of maternal morbidity was 29%. Women with PPH (odds ratio [OR], 6.4 [95% confidence interval, 3.5–11.6]) and preeclampsia (OR, 5.7 [3.5–9.6]) had the highest risk for morbidity. The sensitivity of OEWS for any morbidity was 42% (35%–48%), the specificity was 83% (80%–86%), the positive predictive value was 50% (44%–56%), and the negative predictive value was 78% (76%–80%). Systolic (OR, 6.8 [4.0–11.5]) and diastolic (OR, 3.3 [1.8–6.0]) blood pressure as well as pulse (OR, 2.1 [1.1–4.2]) predicted morbidity the most.

Conclusions
In high-risk women, OEWS revealed one-half of the morbidity. Women with PPH and preeclampsia benefited most from it. Abnormal blood pressure and pulse had the strongest associations with morbidity.
Give Intravenous Bolus Overdose a Brake: User Experience and Perception of Safety Device
Authors: Ng Yasmin Yen Yen , Wan Paul Weng , Chan Kim Poh , Sim Guek Gwee 
Published: September 2020

Objectives
Drugs can come in concentrated solutions that require dilution before intravenous bolus administration. Upon dilution, the syringe can contain more than the required amount of drug. The user may mistakenly administer the full contents of the syringe, resulting in an overdose. In this cross-sectional study, we evaluated user experience and perception of Syringe Brake, a dosage flow restrictor device, as part of the intravenous morphine bolus administration workflow.

Methods
From December 2018 to January 2019, doctors and nurses working in the emergency department of 3 public tertiary hospitals in Singapore were invited to complete a paper-based 11-item 5-point Likert scale survey questionnaire after 3 months of Syringe Brake implementation.

Results
Overall, 77.5% (290/374; 4.11 ± 0.83) of participants were satisfied with the use of Syringe Brake to prevent medication error. Our survey results showed that the top features of Syringe Brake were ease of setting the desired volume to be administered (86.1%; 4.21 ± 0.72), allowing the drug to be titrated safely (84.8%; 4.26 ± 0.77), and giving users the confidence to avoid overdosing the patient (82.1%; 4.21 ± 0.78). Those with hands-on experience with Syringe Brake rated significantly higher for all survey statements except on the perceived ability to prevent error arising from miscommunication (adjusted odds ratio, 1.58 [0.98–2.57]; P = 0.062).

Conclusions
Syringe Brake shows promising potential for adoption to prevent medication errors. The device serves as a constraint to prevent accidental overdose, caused by user unfamiliarity or autopilot administration.
Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097
Authors: Clarke Diana F. , Lommerse Jos , Acosta Edward P. , Cababasay Mae P. , Wang Jiajia , Spector Stephen A. , Chain Anne , Smith Elizabeth , Teppler Hedy , Hazra Rohan , Calabrese Kat , Graham Bobbie , Popson Stephanie , Bryson Yvonne , Mirochnick Mark ,   for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1097 Study Team
Published: September 2020

Background:
HIV treatment of neonates requires identifying appropriate antiretroviral dosing regimens. Our aims were to characterize raltegravir elimination kinetics in low birth weight (LBW) neonates after maternal dosing and to develop a pharmacokinetic model to predict raltegravir plasma concentrations for term and preterm neonates.

Methods:
Mothers living with HIV who received raltegravir during pregnancy and their LBW neonates participated in IMPAACT P1097 study. Up to 6 serial plasma samples were collected from each infant over the first 2 postnatal weeks to characterize raltegravir elimination. Safety laboratory evaluations were obtained, and infants were monitored for 6 weeks for signs of raltegravir toxicity. An integrated maternal–neonatal pharmacokinetic model was developed to predict neonatal raltegravir plasma concentrations.

Results:
Sixteen mothers and their 18 LBW neonates were enrolled. The median (range) raltegravir elimination half-life was 24.4 (10.1–83) hours (N = 17 neonates). No adverse events related to raltegravir in utero exposure were observed. Pharmacokinetic modeling revealed that raltegravir clearance in full-term LBW neonates was well described by allometric scaling but clearance in preterm LBW neonates was better described using slower clearance maturation kinetics. Simulations suggest receipt of the current dosing recommendations in a 34-week gestation neonate would result in plasma concentrations up to 2.5-fold higher than those observed in full-term LBW infants.

Conclusions:
Modeling suggests that prematurity reduces raltegravir clearance and a modified raltegravir dosing regimen will be necessary to avoid elevated plasma raltegravir concentrations.
Brief Report: Longitudinal Associations Between Place of Sex Work and Client Condom Coercion Among Sex Workers in Baltimore, Maryland
Authors: Logie Carmen H. , White Rebecca H. , Galai Noya , Tomko Catherine , Sherman Susan G. 
Published: September 2020

Introduction:
The sex work environment influences sex workers' control over enforcing condom use. Sex work in outdoor and public spaces, compared with indoor spaces, may inhibit condom negotiation. We examined longitudinal associations between public place of sex work and condom coercion among female sex workers.

Methods:
This cohort study involved 5 data collection points over 1 year among female sex workers (N = 246) in Baltimore, Maryland, recruited by targeted sampling. We conducted bivariate analyses to examine associations between currently conducting any sex work in a public place (PPSW, eg, car, abandoned house, street, park/forest, and public bathroom) vs. exclusively indoor sex work (eg, house, motel, and dance club) with sociodemographic, substance use (eg, injection drug use, crack use), and past 3-month condom coercion (eg, client condom refusal/removal). We used logistic regressions with generalized estimating equations and exchangeable correlation structure to examine longitudinal associations between PPSW and subsequent condom coercion, adjusting for sociodemographic and substance use variables.

Findings:
Among participants (race/ethnicity: White: 67.5%; Black/African American: 22.8%; Latina/other ethnicity: n = 9.8%; age range: 18–61), most reported daily injection drug use (58.5%), daily crack use (62.2%), and homelessness (62.2%). Most (88.6%) reported any PPSW at baseline. Current PPSW was associated with increased odds of past 3-month condom coercion (adjusted odds ratio [aOR]: 1.85, 95% confidence interval: 1.16 to 2.94, P = 0.01) compared with indoor sex work, as was daily crack use (aOR 1.67, 95% confidence interval: 1.18 to 2.37).

Conclusions:
Public sex work environments were associated with client condom coercion and confer additional sexual health risks in contexts of illegality. Interventions should address risk disparities in social geographies of sex work.
Changes in Racial and Ethnic Disparities in Estimated Diagnosis Rates of Heterosexually Acquired HIV Infection Among Heterosexual Males in the United States, 2014–2018
Authors: McCree Donna Hubbard , Chesson Harrell W. , Eppink Samuel T. , Beer Linda , Henny Kirk D. 
Published: September 2020

Background:
Diagnoses of HIV infection among male adults and adolescents ≥13 years with infection attributed to heterosexual contact decreased from 2014 through 2018. Racial disparities exist; HIV diagnoses are higher among Black/African American men compared with men of other races/ethnicities. In 2018, Black/African American males accounted for 61% of diagnosed HIV infections attributed to heterosexual contact among males.

Setting:
We used national HIV surveillance data from Atlas Plus to obtain the annual case counts of new HIV diagnoses in males with infection attributed to heterosexual contact and population size for years 2014 through 2018 for males (United States excluding territories) by the racial/ethnic group.

Methods:
We used an adjusted population denominator to calculate rates of diagnoses of HIV infection acquired through heterosexual contact per 100,000 males and 12 absolute and relative measures of disparity to calculate racial/ethnic disparity changes from 2014 to 2018.

Results:
Results from all disparity measures indicate that disparities decreased in 2018, compared with 2014. The decreases ranged from 18.8% to 34.6% among the 4 absolute disparity measures and from 5.3% to 22.7% among the 8 relative disparity measures.

Conclusions:
Despite the decrease, disparities remain. Tailored, effective strategies and interventions are needed to address the social and structural factors associated with HIV risk among heterosexual Black men and to promote continued progress toward reducing disparities.
Review of Doravirine Resistance Patterns Identified in Participants During Clinical Development
Authors: Martin Elizabeth Anne , Lai Ming-Tain , Ngo Winnie , Feng Meizhen , Graham Donald , Hazuda Daria J. , Kumar Sushma , Hwang Carey , Sklar Peter , Asante-Appiah Ernest 
Published: September 2020

Background:
Doravirine (DOR) is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV-1 infection in patients with no known DOR resistance-associated mutations. DOR was rationally designed to address limitations associated with other approved NNRTIs, particularly resistance from common NNRTI resistance-associated mutants containing K103N, Y181C, or G190A reverse transcriptase substitutions.

Setting:
Data to date from both in vitro studies and clinical trials have been compiled to summarize the resistance profile of DOR.

Methods:
We analyzed data from in vitro studies and phase 2 and 3 trials to assess the emergence of resistance-associated mutations and their impact on efficacy among participants treated with DOR.

Results:
DOR exhibited a distinct resistance profile compared with efavirenz and rilpivirine in vitro and in vivo; mutant viruses that were resistant to DOR showed limited cross-resistance to efavirenz and rilpivirine. In clinical trials, the development of DOR resistance-associated substitutions in reverse transcriptase was uncommon.

Conclusion:
Overall, minimal cross-resistance across NNRTIs was observed for DOR and limited development of DOR-related resistance. These data should assist clinicians in further understanding the resistance profile of DOR, so appropriate treatment decisions can be made for their patients.