Infection Is Not Associated With Plasma or Cryoprecipitate Transfusion Volumes in Trauma: A Retrospective Study Using the National Trauma Data Bank.

Background: Packed red blood cell (PRBC) transfusion has been shown to increase nosocomial infection risk in the injured population; however, the post-traumatic infectious risk profiles of non-PRBC blood products are less clear. We hypothesized that plasma (fresh frozen plasma [FFP]), platelet (PLT), and cryoprecipitate administration would not be associated with increased rates of nosocomial infections. Patients and Methods: We performed a retrospective, matched, case-control study utilizing the American College of Surgeons National Trauma Data Bank data for 2019. We included all patients who received any volume of PRBC within four hours of presentation. Our outcome of interest was any infection. Controls were matched to cases using individual matching with a desired 1:3 case:control ratio. Bivariable analysis according to infection status, and multivariable logistic regression modeling the development of infection were then performed upon the matched data. Results: A total of 1,563 infectious cases were matched to 3,920 non-infectious controls. First four-hour transfusion volumes for FFP, PLT, and cryoprecipitate in the infection group exceeded those in the control group. The first four-hour FFP transfusion volume (per unit odds ratio [OR], 1.02; 95% confidence interval [CI], 0.99-1.04; p = 0.28) and cryoprecipitate transfusion volume (per unit OR, 1.01; 95% CI, 0.99-1.02; p = 0.43) were similar in cases and controls whereas PLT transfusion volume (per unit OR, 0.92; 95% CI, 0.86-0.98; p = 0.01) was lower in cases of infection than in controls. Conclusions: Fresh frozen plasma, PLT, and cryoprecipitate transfusion volumes were not independent risk factors for the development of nosocomial infection in a trauma population. PLT transfusion volume was associated with less infection.

Assessing Second Debridement Timing and Mortality in Necrotizing Soft Tissue Infections.

BACKGROUND: Patients with necrotizing soft tissue infection undergo an average of 4-5 debridements per hospital admission. Optimal timing for initial debridement is emergent. Second debridement is universally recommended to occur within 24 hours of the first, but no studies have successfully evaluated this time frame. Prior work has suggested that delays in second debridement are associated with increased mortality, and that few patients receive second debridement within 24 hours. METHODS: We performed a retrospective cohort study at a single center from 01/01/08 to 09/01/2021. The explanatory variable was whether the subject received second debridement within 24 hours of initial debridement. The primary outcome was in-hospital mortality. Baseline characteristics were collected. Subjects were stratified into 2 groups by time between first and second debridement: <24 and ≥24 hours. Variables were compared using Fisher's exact and Wilcoxon rank-sum tests. RESULTS: 77 patients met inclusion criteria. The median overall time to second debridement was 40 hours. 12 subjects received second debridement within 24 hours (15.6%). There was no difference in in-hospital mortality between the <24 (n = 3, 25.0%) and ≥24-hour second debridement groups (n = 4, 6.2%; P = .07). The 2 groups did not differ by secondary outcomes, including total number of debridements, ICU LOS, or wound closure. CONCLUSION: No difference in mortality was observed between subjects undergoing second debridement within 24 vs after 24 hours. Only 16% of subjects received second debridement within the recommended 24-hour time interval. Further study is required to identify the optimal timing of second debridement.

Disaster planning for a surgical surge: when mass trauma threatens to overwhelm your operating rooms.

Mass casualty events particularly those requiring multiple simultaneous operating rooms are of increasing concern. Existing literature predominantly focuses on mass casualty care in the emergency department. Hospital disaster plans should include a component focused on preparing for multiple simultaneous operations. When developing this plan, representatives from all segments of the perioperative team should be included. The plan needs to address activation, communication, physical space, staffing, equipment, blood and medications, disposition offloading, special populations, and rehearsal.

To leave or not to leave: American Association for the Surgery of Trauma (AAST) panel discussion on personal, parental, and family leave.

Navigating planned and emergent leave during medical practice is very confusing to most physicians. This is especially challenging to the trauma and acute care surgeon, whose practice is unique due to overnight in-hospital call, alternating coverage of different services, and trauma center's staffing challenges. This is further compounded by a surgical culture that promotes the image of a 'tough' surgeon and forgoing one's personal needs on behalf of patients and colleagues. Frequently, surgeons find themselves having to make a choice at the crossroads of personal and family needs with work obligations: to leave or not to leave. Often, surgeons prioritize their professional commitment over personal wellness and family support. Extensive research has been conducted on the topic of maternity leave and inequality towards female surgeons, primarily focused on trainees. The value of paternity leave has been increasingly recognized recently. Consequently, significant policy changes have been implemented to support trainees. Practicing surgeon, however, often lack such policy support, and thus may default to local culture or contractual agreement. A panel session at the American Association for the Surgery of Trauma 2022 annual meeting was held to discuss the current status of planned or unanticipated leave for practicing surgeons. Experiences, perspectives, and propositions for change were discussed, and are presented here.

In-hospital, 30- and 90-day mortality in elderly trauma patients with operative feeding tubes.

BACKGROUND: Nutrition is essential in the treatment of elderly trauma patients (ETP). ETP experience dysphagia at rates six times higher than the non-trauma elderly population (NTEP) and are at increased risk for malnutrition. Operative feeding tube (OFT) placement is often used to aid with the nutritional management of ETP. Elderly patients experience higher rates of morbidity and mortality when compared to the general population, especially in the traumatic setting, with some data suggesting in-hospital mortality as high as 10%. However, the mortality rates and associated comorbidities associated with OFT in ETP are unknown. The purposes of this study were to establish the mortality rate in hospital as well as 30- and 90-days following discharge among elderly trauma patients (ETP) receiving OFT, and to assess factors associated with mortality within this population. METHODS: A retrospective review of all trauma patients from a single Level I Trauma Center from 01/2010-09/2020 was conducted. Exclusion criteria were patients under 65 years of age or those with previously placed OFT. Demographics, comorbidities, injury mechanisms, injury severity scores (ISS), and OFT data were collected from the institutional trauma registry. Mortality data were obtained using the Social Security Death Index. Mortality at discharge, 30 days, and 90 days following discharge were the primary outcomes. Bivariate analysis was conducted to compare characteristics and comorbidities of patients alive and dead at the time points of interest. RESULTS: There were 151 ETP who received OFT. Patients were largely male (67.5%), severely injured via a blunt mechanism (95%), and had a median age of 76 years. 11 (7.3%) experienced in-hospital mortality following feeding tube placement, 21 (13.9%) died within 30 days, and 31 (20.5%) within 90 days. Bivariate analysis demonstrated that ETP who died were more likely to have a history of dementia (p = 0.004), congestive heart failure (p = 0.014), and end-stage liver disease (p = 0.034). No other patient or injury factors were associated with mortality after OFT placement. CONCLUSION: Mortality rates for ETP with OFT were higher than anticipated, yet favorable compared to recently reported data. Patients who died were more likely to have dementia, CHF, or ESLD than those who survived. The few comorbidities associated with mortality suggest that nearly all ETP who undergo OFT placement are at risk for mortality. Additionally, the data highlights the importance of early goals of care discussions for ETP and their loved ones when operative feeding tubes are being considered. LEVEL OF EVIDENCE: Level III. STUDY TYPE: Prognostic/Therapeutic/Diagnostic Test/Economic/Decision.

Defining the Mortality Rate of Elderly Trauma Patients With Operative Feeding Tubes.

INTRODUCTION: Placement of feeding tubes in elderly patients has not been studied in elderly trauma patients. The objectives of this study were to determine in-hospital mortality in elderly trauma patients receiving operative feeding tubes and to identify factors associated with in-hospital mortality. METHODS: A retrospective study utilizing 2017 National Trauma Data Bank data was conducted. Trauma patients aged 65 and older with operative feeding tubes were included. Demographic, injury, comorbidity, and general hospital course data were analyzed. Two cohorts were constructed: survival and non-survival to hospital discharge. Bivariate analysis and logistic regression were performed to determine factors independently associated with in-hospital mortality. RESULTS: A total of 3,398 patients were analyzed with 331 (9.7%) dying during hospitalization. Patients had a median age of 75 years and sustained severe injuries (median ISS 17). Patients who died were older (76 vs. 75 years, p = .03), more severely injured (ISS 22 vs. 17, p < .001), had a higher geriatric trauma outcome score (134 vs. 121, p < .001), and had lower rates of dementia (8 vs. 13%, p = .01). Multivariate regression showed male sex, lower admission GCS, higher Charlson Comorbidity Index, and an Advance Directive Limiting Care (ADLC) were independently associated with in-hospital mortality. Dementia diagnosis was negatively associated with in-hospital mortality. CONCLUSIONS: The in-hospital mortality rate for elderly trauma patients with operative feeding tubes placed was notably high. Identifying factors associated with in-hospital mortality will serve to assist providers in counseling patients and caregivers about the outcomes of operative feeding tube placement in this patient population.

Antibiotic Initiation Timing and Mortality in Trauma Patients With Ventilator-Associated Pneumonia.

BACKGROUND: Early antibiotic initiation is considered a cornerstone in the management of ventilator-associated pneumonia (VAP). However, recent data suggests that early antibiotic initiation may not be necessary in all cases. Additionally, the benefits of early antibiotic administration for infection have not been studied in a dedicated trauma population. This study's aim was to evaluate the impact of antibiotic administration timing on in-hospital mortality in trauma patients with VAP. METHODS: This retrospective case-control study identified all trauma patients at a single level 1 academic trauma center from 2016 to 2020. Patients with a TQIP-defined VAP were included and stratified into 2 subgroups by in-hospital mortality. Time interval between airway culture and antibiotic initiation was gathered. Baseline measures of injury and illness severity were collected. Univariate analysis of the data was performed. RESULTS: Forty-five patients met inclusion criteria. Overall, 80% of patients survived admission (n = 36) and 20% of patients did not survive admission (n = 9). There were no significant differences in baseline characteristics or cultured organism between survivors and non-survivors. The median time interval between airway culture and antibiotic initiation was 2 hours (IQR 0-4.5) for survivors, and 0 hours (IQR 0-0) for non-survivors (P = .07). Antibiotics were administered within 1 hour of airway culture for 33.3% of survivors, and 77.8% of non-survivors (P = .02). CONCLUSIONS: In a population of trauma patients with VAP, survivors had antibiotics initiated in more delayed fashion than non-survivors. These findings question the primacy of early antibiotic administration for suspected infection.

Acute stress disorder in trauma patients discharged in 72 h or less.

INTRODUCTION: Acute Stress Disorder (ASD) is a psychiatric condition affecting individuals exposed to trauma and requires the presence of symptoms 72 h following trauma. Patients evaluated for trauma related injury are often discharged prior to 72 h, but the risk of ASD remains. The aim of this study was to quantify the rate of acute stress disorder in trauma patients admitted for fewer than 72 h. MATERIALS AND METHODS: We performed a prospective, observational study of trauma patients discharged prior to 72 h at our ACS Level I Trauma Center between June 2020 and December 2020. Participants were administered an institutional screening tool following hospital discharge. Positive screens were then administered the diagnostic Acute Stress Disorder Scale (ASDS) tool. The rate of ASD was calculated and bivariate comparisons between participants who met diagnostic criteria and those who did not were performed to identify risk factors for the development of acute stress disorder. RESULTS: 116 patients participated (median age 54, 66% male, median injury severity score (ISS) 9). Forty patients (34%) screened positive via the institutional screening tool, with 14 (12%) ultimately demonstrating ASD by ASDS. Participants who developed ASD were more likely to be female (71 vs. 30%, p = 0.005), African American (43 vs. 12% White, p = 0.016), spend less time in the hospital overall (1-2 vs. 2-3 days. p = 0.045), and have a lower ISS (6 vs. 9, p = 0.041). CONCLUSIONS: Our study found 12% of trauma patients discharged prior to 72 h developed ASD. These data point to possible benefit in reassessment of injured patients following hospital discharge and the importance of developing pathways for trauma patients to access mental health resources.

Aspiration Risk Factors in Hospitalized Patients Following Trauma.

Introduction: Risk factors for aspiration are not well characterized in the trauma patient population. Improved understanding is important due to features of this patient population that place them at high risk for morbidity and mortality with aspiration. Methods: In a retrospective analysis of patients who suffered a traumatic injury from 2016 to 2018, potential risk factors were recorded and analyzed with logistic regression to evaluate the trauma patient at risk for aspiration. Results: Of the 146 patient charts analyzed, 56 (38%) had at least one documented aspiration event, while 90 (62%) patients had none. Multivariate logistic regression found a significant association between impaired consciousness and aspiration events (p = 0.012). Conclusions: This study was a novel characterization of trauma patients likely to have experienced an aspiration event while hospitalized. The results suggested candidate risk factors for aspiration exist in a trauma-specific population. Impaired consciousness is likely to show a significant association with aspiration in trauma patients in future studies.

Factors associated with receipt of intracranial pressure monitoring in older adults with traumatic brain injury.

BACKGROUND: The Brain Trauma Foundation (BTF) Guidelines for the Management of Severe Traumatic Brain Injury (TBI) include intracranial pressure monitoring (ICPM), yet very little is known about ICPM in older adults. Our objectives were to characterize the utilization of ICPM in older adults and identify factors associated with ICPM in those who met the BTF guidelines. METHODS: We analyzed data from the American Association for the Surgery of Trauma Geriatric TBI Study, a registry study conducted among individuals with isolated, CT-confirmed TBI across 45 trauma centers. The analysis was restricted to those aged ≥60. Independent factors associated with ICPM for those who did and did not meet the BTF guidelines were identified using logistic regression. RESULTS: Our sample was composed of 2303 patients, of whom 66 (2.9%) underwent ICPM. Relative to Glasgow Coma Scale (GCS) score of 13 to 15, GCS score of 9 to 12 (OR 10.2; 95% CI 4.3 to 24.4) and GCS score of <9 (OR 15.0; 95% CI 7.2 to 31.1), intraventricular hemorrhage (OR 2.4; 95% CI 1.2 to 4.83), skull fractures (OR 3.6; 95% CI 2.0 to 6.6), CT worsening (OR 3.3; 95% CI 1.8 to 5.9), and neurosurgical interventions (OR 3.8; 95% CI 2.1 to 7.0) were significantly associated with ICPM. Restricting to those who met the BTF guidelines, only 43 of 240 (18%) underwent ICPM. Factors independently associated with ICPM included intraparenchymal hemorrhage (OR 2.2; 95% CI 1.0 to 4.7), skull fractures (OR 3.9; 95% CI 1.9 to 8.2), and neurosurgical interventions (OR 3.5; 95% CI 1.7 to 7.2). DISCUSSION: Worsening GCS, intraparenchymal/intraventricular hemorrhage, and skull fractures were associated with ICPM among older adults with TBI, yet utilization of ICPM remains low, especially among those meeting the BTF guidelines, and potential benefits remain unclear. This study highlights the need for better understanding of factors that influence compliance with BTF guidelines and the risks versus benefits of ICPM in this population. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Empowering the affected: Informing community-based solutions through interviews with survivors of interpersonal firearm violence-Perspectives of survivors of firearm injuries.

BACKGROUND: Firearm violence remains epidemic in the United States, with interpersonal gun violence leading to significant morbidity and mortality. Interpersonal violence has strong associations with social determinants of health, and community-specific solutions are needed to address root causes. We hypothesized that open-ended interviews with survivors of interpersonal firearm violence would identify themes in individual and community-level factors that contribute to ongoing violence. METHODS: Between July 2017 and November 2019, we performed a mixed-methods study in which qualitative and quantitative data were obtained from survivors of interpersonal firearm violence admitted to our urban level I trauma center. Qualitative data were obtained through semistructured, open-ended interviews with survivors. Quantitative data were obtained via survey responses provided to these same individuals. Qualitative and quantitative data were then used to triangulate and strengthen results. RESULTS: During the study period, 51 survivors were enrolled in the study. The most common cause of firearm violence reported by survivors was increased gang and drug activity (n = 40, 78%). The most common solution expressed was to reduce drug and gang lifestyle by offering jobs and educational opportunities to afflicted communities to improve opportunities (n = 35, 69%). Nearly half of the survivors (n = 23, 45%) believe that firearm violence should be dealt with by the affected community itself, and another group of survivors believe that it should be through partnership between the community and trauma centers (n = 19, 37%). CONCLUSION: Interviews with survivors of firearm violence at our urban level I trauma center suggest that drug and gang lifestyle perpetuate ongoing violence and that this would best be overcome by improving access to quality education and job opportunities. To address endemic firearm violence in their communities, trauma centers should identify opportunities to partner in developing programs that provide improved education, job access, and conflict mediation. LEVEL OF EVIDENCE: Prognostic and epidemiological, level I.

The Impact of the Tertiary Survey in an Established Trauma Program.

INTRODUCTION: The trauma tertiary survey (TTS) was first described in 1990 and is recognized as an essential practice in trauma care. The TTS remains effective in detecting secondary injuries in the modern era. METHODS: Trauma patients discharged between August 1, 2016, and December 31, 2016, were identified in our trauma registry. Collected data include TTS completion rates, detection of injuries, type of provider, and timing. TTS documentation was qualitatively evaluated. RESULTS: Out of 407 patients, 264 patients (65%) received a TTS. Injury detection rate was 1.1.%. Average time to TTS was 41 hours. TTS were completed by resident physicians (46%) and advanced practice providers (APPs; 46%). TTS documentation was more complete for APPs than for resident physicians. CONCLUSION: TTS remains an integral component of modern trauma care. Ongoing education on the significance of TTS and the importance of thorough documentation is essential. Provision of real-time feedback to providers is also critical for improving current practices.

Perceptions of Equity and Inclusion in Acute Care Surgery: From the #EAST4ALL Survey.

OBJECTIVES AND BACKGROUND: The aim of this study was to characterize equity and inclusion in acute care surgery (ACS) with a survey to examine the demographics of ACS surgeons, the exclusionary or biased behaviors they witnessed and experienced, and where those behaviors happen. A major initiative of the Equity, Quality, and Inclusion in Trauma Surgery Practice Ad Hoc Task Force of the Eastern Association for the Surgery of Trauma was to characterize equity and inclusion in ACS. To do so, a survey was created with the above objectives. METHODS: A cross-sectional, mixed-methods anonymous online survey was sent to all EAST members. Closed-ended questions are reported as percentages with a cutoff of α = 0.05 for significance. Quantitative results were analyzed focusing on mistreatment and bias. RESULTS: Most respondents identified as white, non-Hispanic and male. In the past 12 months, 57.5% of females witnessed or experienced sexual harassment, whereas 48.6% of surgeons of color witnessed or experienced racial/ethnic discrimination. Sexual harassment, racial/ethnic prejudice, or discrimination based on sexual orientation/sex identity was more frequent in the workplace than at academic conferences or in ACS. Females were more likely than males to report unfair treatment due to age, appearance or sex in the workplace and ACS (P ≤ 0.002). Surgeons of color were more likely than white, non-Hispanics to report unfair treatment in the workplace and ACS due to race/ethnicity (P < 0.001). CONCLUSIONS: This is the first survey of ACS surgeons on equity and inclusion. Perceptions of bias are prevalent. Minorities reported more inequity than their white male counterparts. Behavior in the workplace was worse than at academic conferences or ACS. Ensuring equity and inclusion may help ACS attract and retain the best and brightest without fear of unfair treatment.

Impact of a Streamlined Trauma-Focused Smartphone Application on Protocol Compliance and Delivery of Care.

BACKGROUND: In November 2015, an institution-specific mobile application (app) was created to provide rapid access to trauma protocols. The app was tested, and the results suggested that the app was difficult to use as it linked to web-based databases. In June 2018, the app was redesigned with protocol infographics and algorithms that are available offline, eliminating the need to scroll through web pages. We tested the redesigned app's ability to provide information quickly, in a user-friendly manner. METHODS: This was a prospective, experimental analysis of a streamlined, institution-specific trauma app. Participants included general surgery residents, advanced practice providers, and attending trauma surgeons. The primary outcomes of measure were time to complete an exam with trauma scenarios and the number of questions answered correctly. The primary exposure of interest was access to the app during the exam. RESULTS: There were 35 study participants: 17 with the 2018 version of the app to complete the quiz and 18 without app access. The group with access scored higher than those without access (70% versus 50%, P = 0.0005) as well as those with the old version of the app in the 2015 study (70% versus 55%, P = 0.0250). App access eliminated a significant difference in exam scores between residents and attendings that was present without the app. CONCLUSIONS: A mobile app with offline access to protocol infographics and algorithms gives providers access to recommended practices and may improve delivery of trauma care. The app is helpful to residents and helps bridge the knowledge gap between groups when the app is not available. LEVEL OF EVIDENCE: Level III.

A comparison between the TEG 6s and TEG 5000 analyzers to assess coagulation in trauma patients.

BACKGROUND: Trauma-induced coagulopathy is a major driver of mortality following severe injury. Viscoelastic goal-directed resuscitation can reduce mortality after injury. The TEG 5000 system is widely used for viscoelastic testing. However, the TEG 6s system incorporates newer technology, with encouraging results in cardiovascular interventions. The purpose of this study was to validate the TEG 6s system for use in trauma patients. METHODS: Multicenter noninvasive observational study for method comparison conducted at 12 US Levels I and II trauma centers. Agreement between the TEG 6s and TEG 5000 systems was examined using citrated kaolin reaction time (CK.R), citrated functional fibrinogen maximum amplitude (CFF.MA), citrated kaolin percent clot lysis at 30 minutes (CK.LY30), citrated RapidTEG maximum amplitude (CRT.MA), and citrated kaolin maximum amplitude (CK.MA) parameters in adults meeting full or limited trauma team criteria. Blood was drawn ≤1 hour after admission. Assays were repeated in duplicate. Reliability (TEG 5000 vs. TEG 6s analyzers) and repeatability (interdevice comparison) was quantified. Linear regression was used to define the relationship between TEG 6s and TEG 5000 devices. RESULTS: A total of 475 patients were enrolled. The cohort was predominantly male (68.6%) with a median age of 49 years. Regression line slope estimates (ß) and linear correlation estimates (p) were as follows: CK.R (ß = 1.05, ρ = 0.9), CFF.MA (ß = 0.99, ρ = 0.95), CK.LY30 (ß = 1.01, ρ = 0.91), CRT.MA (TEG 6s) versus CK.MA (TEG 5000) (ß = 1.06, ρ = 0.86) as well as versus CRT.MA (TEG 5000) (ß = 0.93, ρ = 0.93), indicating strong reliability between the devices. Overall, within-device repeatability was better for TEG 6s versus TEG 5000, particularly for CFF.MA and CK.LY30. CONCLUSION: The TEG 6s device appears to be highly reliable for use in trauma patients, with close correlation to the TEG 5000 device and equivalent/improved within-device reliability. Given the potential advantages of using the TEG 6s device at the site of care, confirmation of agreement between the devices represents an important advance in diagnostic testing. LEVEL OF EVIDENCE: Diagnostic test, level II.

The effect of hemorrhage control adjuncts on outcome in severe pelvic fracture: A multi-institutional study.

BACKGROUND: Hemodynamically unstable patients with severe pelvic fracture are a significant challenge to trauma surgeons and have high mortality. Significant variability across institutions in hemorrhage control adjuncts used to quell pelvic bleeding has been demonstrated. However, the effect of these methods on time to definitive bleeding control, type of resuscitation given, and outcomes remains unknown. We sought to elucidate those effects. METHODS: This was a multicenter retrospective review of severe pelvic fracture patients in shock between 2011 and 2016. Shock was defined as systolic blood pressure less than 90 mm Hg, heart rate greater than 120 beats per minute, or base deficit less than -5. Definitive bleeding control was defined as time to surgical control in the operating room or embolization by interventional radiology. Significance level was at p less than 0.05. RESULTS: A total of 279 severe pelvic fracture patients with shock on admission from 12 trauma centers were included. The cohort was primarily male (62%) with median (interquartile range) age of 40 years (28-54 years), Injury Severity Score of 38 (29-50), and Glasgow Coma Scale score of 13 (3-15). Overall mortality was 32%. The most common adjunct used was pelvic binder (50%) followed by no adjunct (30.5%); least common was resuscitative balloon occlusion of the aorta (REBOA) (2.5%). Preperitoneal packing alone and REBOA alone/with other adjunct(s) resulted in the fastest times to operating room/interventional radiology but also had the highest blood utilization and mortality rates. Resuscitative balloon occlusion of the aorta was most often used along with pelvic binder (6 of 13; 46%). CONCLUSION: Marked variation in management of severe pelvic fracture patients in shock indicates the need for a standardized approach to maximize outcomes and minimize transfusion requirements. The use of preperitoneal packing and/or REBOA yielded fastest times to definitive bleeding control. However, REBOA continues to be infrequently used. Future prospective analysis of this combination needs further validation in patients with severe pelvic hemorrhage. LEVEL OF EVIDENCE: Therapeutic study, level IV.