A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns.

BACKGROUND: A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep partial-thickness thermal burns with intact dermal elements. METHODS: Adult patients with 3 % to < 50 % total body surface area burns were treated with a single application of ≤ 1:1 meshed StrataGraft and followed for 24 weeks. Primary endpoint was count and percentage of patients with treatment-emergent adverse events (TEAEs). Secondary endpoints included confirmed wound closure (WC) at Week 12, durable WC at Week 24, time to WC, scar evaluation, and wound infection-related events. RESULTS: Fifty-two patients with 96 treatment sites were enrolled. Pruritus was the most common TEAE (22 patients [42.3 %]). Twenty serious TEAEs occurred in 10 patients (19.2 %); none were related to StrataGraft. There were 4 (7.7 %) deaths (aspiration, myocardial infarction, self-injury, Gram-negative rod sepsis); none were related to StrataGraft. Confirmed WC was achieved by Week 12 in 33 patients (63.5 %; 95 % CI: 50.4-76.5 %) and 69 treatment sites (71.9 %; 95 % CI: 62.9-80.9 %). Durable WC was achieved by Week 24 in 29 patients (55.8 %; 95 % CI: 42.3-69.3 %) and 58 treatment sites (60.4 %; 95 % CI: 50.6-70.2 %). CONCLUSIONS: StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings.

Review of machine learning for optical imaging of burn wound severity assessment.

Significance: Over the past decade, machine learning (ML) algorithms have rapidly become much more widespread for numerous biomedical applications, including the diagnosis and categorization of disease and injury. Aim: Here, we seek to characterize the recent growth of ML techniques that use imaging data to classify burn wound severity and report on the accuracies of different approaches. Approach: To this end, we present a comprehensive literature review of preclinical and clinical studies using ML techniques to classify the severity of burn wounds. Results: The majority of these reports used digital color photographs as input data to the classification algorithms, but recently there has been an increasing prevalence of the use of ML approaches using input data from more advanced optical imaging modalities (e.g., multispectral and hyperspectral imaging, optical coherence tomography), in addition to multimodal techniques. The classification accuracy of the different methods is reported; it typically ranges from ∼70% to 90% relative to the current gold standard of clinical judgment. Conclusions: The field would benefit from systematic analysis of the effects of different input data modalities, training/testing sets, and ML classifiers on the reported accuracy. Despite this current limitation, ML-based algorithms show significant promise for assisting in objectively classifying burn wound severity.

Unnecessary Early Gastrostomy for Trauma Patients.

While early gastrostomy tube placement (GTP) may decrease hospital length of stay and facilitate disposition, GTP may be unnecessary as some patients regain the ability to eat earlier than expected. No guidelines currently exist regarding optimal GTP timing or minimum duration of need indicating appropriateness of GTP. This retrospective (9/2017-12/2019) single center study evaluated the incidence of adequate (>75%) oral caloric intake (ACI) after GTP during index hospitalization and associated characteristics before discharge. Bivariate analyses were performed to compare patients achieving ACI and patients not achieving ACI at discharge. By discharge, 10 (12.5%) patients achieved ACI and 6 (7.5%) had their GT removed prior to discharge suggesting many patients undergo unnecessary GTP. Also, 6 (7.5%) patients suffered GTP-related complications. Future multicenter studies are needed to corroborate these findings and establish GTP guidelines for trauma patients to avoid unnecessary GT procedures and associated morbidities.

The Effects of the COVID-19 Pandemic on Burn Clinic.

The COVID-19 pandemic has led to anxiety and fears for the general public. It is unclear how the behavior of people with acute burns and the services available to them has changed during the pandemic. The aim of our observational study was to evaluate our clinic's experience with patients presenting with burns during the first 10 months of the COVID-19 pandemic and determine if delays in presentation and healthcare delivery exist within our burn population. Patients referred to our clinic from March 1, 2020 to December 15, 2020 were reviewed for time of presentation after injury. We defined a true delay in presentation of >5 days from date of injury to date of referral for patients who were not inpatients at our facility or received initial care elsewhere prior to referral. Of the 246 patients who were referred to our clinic, during this time period, 199 patients (80.89%) attended their appointments. Our in-person clinic volume from referrals increased in July 2020 with a sharp decrease in August 2020. Our total clinic volume decreased in 2020 from 2019 by about 14%. Referrals to our clinic decreased in 2020 from 2019 by about 34%. Video telehealth visits did not account for the decrease in visits. There was low incidence of delays in presentation to our clinic during the pandemic. Additional investigation is necessary to see if the incidence of burn injury decreased. Despite the pandemic, our clinic remained ready and open to serve the burn population.

Comparison of Same and Different Level Height Falls on Subsequent Midline Shift in Pediatric Traumatic Brain Injury.

OBJECTIVES: Up to 44% of pediatric traumatic brain injury occurs as a result of a fall. We hypothesized that a fall from height is associated with higher risk for subsequent midline shift in pediatric traumatic brain injury compared with a fall from same level. METHODS: The Pediatric Trauma Quality Improvement Program 2016 was queried for kids younger than 16 years with an injury in the abbreviated injury scale for the head after a fall. Patients with midline shift were identified. A logistic regression model was used for analysis. RESULTS: The risk of a midline shift was lower in those with a fall from a height (odds ratio, 0.64; 95% confidence interval, 0.46-0.91, P = 0.01). In kids older than 4 years, there was no association between the level of height of the fall and subsequent midline shift (P = 0.62). The risk for midline shift in kids younger than 4 years after a fall from same level was lower (odds ratio, 0.40; 95% confidence interval, 0.24-0.67; P = 0.001). CONCLUSIONS: In kids with traumatic brain injury, trauma activations due to falls from the same level are associated with a 2.5-fold higher risk of subsequent midline shift, compared with falling from height.

Characterization of Macrophage and Cytokine Interactions with Biomaterials Used in Negative-Pressure Wound Therapy.

Macrophages are innate immune cells that help wounds heal. Here, we study the potential immunomodulatory effects of negative-pressure wound therapy (NPWT) materials on the macrophage inflammatory response. We compared the effects of two materials, Granufoam™ (GF) and Veraflo Cleanse™ (VC), on macrophage function in vitro. We find that both materials cause reduced expression of inflammatory genes, such as TNF and IL1B, in human macrophages stimulated with bacterial lipopolysaccharide (LPS) and interferon-gamma (IFNγ). Relative to adherent glass control surfaces, VC discourages macrophage adhesion and spreading, and may potentially sequester LPS/IFNγ and cytokines that the cells produce. GF, on the other hand, was less suppressive of inflammation, supported macrophage adhesion and spreading better than VC, and sequestered lesser quantities of LPS/IFNγ in comparison to VC. The control dressing material cotton gauze (CT) was also immunosuppressive, capable of TNF-α retention and LPS/IFNγ sequestration. Our findings suggest that NPWT material interactions with cells, as well as soluble factors including cytokines and LPS, can modulate the immune response, independent of vacuum application. We have also established methodological strategies for studying NPWT materials and reveal the potential utility of cell-based in vitro studies for elucidating biological effects of NPWT materials.

What Happens After a Positive Screen for Depression and Posttraumatic Stress Disorder in the Outpatient Burn Clinic?

Multiple reports have demonstrated a wide prevalence of both depression and posttraumatic stress disorder (PTSD) within 1 year of burn injury. The purpose of this study is to determine outcomes of burn patients after a positive outpatient screen for depression or PTSD at an American Burn Association-verified burn center. All patients who screened positive were offered referral for psychologic and/or psychiatric counseling. Rescreening was performed with a goal of approximately 6 months. A total of 445 patients were enrolled with 91 (20.6%) screening positive for depression and 59 (13.4%) for PTSD. TBSA burned was associated with a positive screen for depression (P = .008) and PTSD (P = .012) while electrical injury was associated with a positive screen for depression (P = .029). Rescreening was done in 15.5% with 23% rescreening positive for depression and 15% for PTSD. The study validated the need for early screening and referral for psychologic and/or psychiatric counseling in this population.

Problems and Costs That Could Be Addressed by Improved Burn and Wound Care Training in Health Professions Education.

The current system of burn care delivery attempts to meet the needs of the nearly 500 000 patients in the United States who require medical treatment annually. However, specialization of care and lack of fundamental burn and wound care knowledge among graduating medical trainees has unintended consequences, leaving the system inefficient, with inherent inequities in care delivery and with the potential to be overwhelmed in a mass casualty event. While increasing accessibility to specialty burn centers through technology could mitigate some of these problems, increased education is more practical. The implementation of a formal wound care curriculum in medical school would address the problems associated with chronic wounds in the United States. Additionally, this curriculum would be a natural extension of exposure to the basics of burn care, a relevant skill set in any specialty.

Analysis of Endoscopic Retrograde Cholangiopancreatography after Positive Intraoperative Cholangiogram: Is It Necessary?

The necessity of routine endoscopic retrograde cholangiopancreatography (ERCP) after positive intraoperative cholangiogram (IOC) during laparoscopic cholecystectomy is not well defined. We aimed to examine the incidence of positive IOC among patients who undergo IOC during cholecystectomy and the rate of subsequent ERCP stone extraction. The Nationwide Inpatient Sample database was reviewed for all patients undergoing cholecystectomy with IOC from 2002 to 2012. Patients were then analyzed for ERCP and stone extraction. A total of 73,508 patients who underwent cholecystectomy with IOC for a diagnosis of acute cholecystitis and found to have a bile duct stone were identified. Of these patients, 5915 underwent subsequent ERCP. In the patients that underwent subsequent ERCP, 1478 had a documented stone extraction during ERCP. The rate of stone extraction in the ERCP subset is 25 per cent, which is 2 per cent of all patients who had a positive IOC. The rate of stone extraction after positive IOC is low. Positive IOC may not warrant a routine postoperative ERCP. Our results suggest that clinical monitoring of patients with positive IOC is reasonable, as the majority of patients with a positive IOC ultimately have no stone extraction.

A Case of Argyria and Acute Leukopenia Associated with the Use of an Antimicrobial Soft Silicone Foam Dressing.

Silver has had an important role in preventing burn-related infections for decades. Relatively few side effects is one factor that has led to its wide spread use. Here, the authors present the first case of argyria, acute leukopenia, and possibly acute kidney injury associated with the use of a silver-containing soft silicone foam dressing. A 56-year-old female was transferred to the burn center with an exfoliating skin condition involving 70% TBSA diagnosed as toxic epidermal necrolysis associated with trimethoprim/sulfamethoxazole. On presentation she appeared to have clinical sepsis and was started on vancomycin and piperacillin/tazobactam. Clinical sepsis resolved within several days. Initial wound care consisted of daily topical double antibiotic and 3% bismuth tribromophenate petroleum gauze. After several days, the wounds were covered with a silver-containing soft silicone foam dressing. After 7 days, the leukocyte count declined from 18,000 to 600/cm. Silver toxicity was suspected and the dressings removed. Initial serum silver level was 190 and 249 µg/L 1 week later. The leukocyte level normalized within 7 days. Over the following days and weeks, the patient's skin began to show blue-gray coloration consistent with argyria. The patient subsequently developed acute kidney injury requiring hemodialysis and multiple organ failure. Although controversy exists about the causal relationship between silver-containing dressings and leukopenia, the authors believe that this case represents a case of acute leukopenia and argyria from the use of a silver-containing soft silicone foam dressing. It may have been a contributing factor to the development of acute kidney injury as well.

A Survey of Mechanical Ventilator Practices Across Burn Centers in North America.

Burn injury introduces unique clinical challenges that make it difficult to extrapolate mechanical ventilator (MV) practices designed for the management of general critical care patients to the burn population. We hypothesize that no consensus exists among North American burn centers with regard to optimal ventilator practices. The purpose of this study is to examine various MV practice patterns in the burn population and to identify potential opportunities for future research. A researcher designed, 24-item survey was sent electronically to 129 burn centers. The χ, Fisher's exact, and Cochran-Mantel-Haenszel tests were used to determine if there were significant differences in practice patterns. We analyzed 46 questionnaires for a 36% response rate. More than 95% of the burn centers reported greater than 100 annual admissions. Pressure support and volume assist control were the most common initial MV modes used with or without inhalation injury. In the setting of Berlin defined mild acute respiratory distress syndrome (ARDS), ARDSNet protocol and optimal positive end-expiratory pressure were the top ventilator choices, along with fluid restriction/diuresis as a nonventilator adjunct. For severe ARDS, airway pressure release ventilation and neuromuscular blockade were the most popular. The most frequently reported time frame for mechanical ventilation before tracheostomy was 2 weeks (25 of 45, 55%); however, all respondents reported in the affirmative that there are certain clinical situations where early tracheostomy is warranted. Wide variations in clinical practice exist among North American burn centers. No single ventilator mode or adjunct prevails in the management of burn patients regardless of pulmonary insult. Movement toward American Burn Association-supported, multicenter studies to determine best practices and guidelines for ventilator management in burn patients is prudent in light of these findings.

Patients With Burns Versus Patients With Complex Skin and Soft-Tissue Disease: An Analysis of Outcomes in the United States.

With the incidence of burns decreasing nationally, burn units are caring for more patients with nonburn conditions. The American Burn Association National Burn Repository does not currently report data regarding patients cared for in burn units without a diagnosis of burn. Using the National Inpatient Sample, we examined if there was a difference in characteristics and outcomes of patients admitted for burns compared with those with a primary admitting diagnosis of necrotizing skin infections and soft-tissue infections and exfoliative skin conditions. This is a retrospective study querying the National Inpatient Sample database to identify 56,102 patients from 2007 to 2012 who were admitted with a diagnosis of a burn (burn group). This group was then compared with 375,857 patients who had a primary admitting diagnosis of a necrotizing skin and/or soft-tissue infection or exfoliative skin conditions (nonburn group). Clinical and demographic variables were analyzed to determine characteristics of each patient group including length of stay, disposition, complications, comorbidities, and mortality. The average age of the nonburn group was 63.7 years, whereas the average age of the burn group was 40.1 years. Overall length of stay was higher in the nonburn patients than in burn patients (10.5 vs 8.4 days, P < .001). Nonburn patients had a higher rate of medical comorbidities. Nonburn patients had higher rates of mortality (6.9% vs 2.7%) and complications. After adjusting for confounders, such as age, gender, ethnicity, and comorbidities, the nonburn group was found to have higher rates of all recorded complications. Burn patients were more likely to undergo a major operating room procedure (39.3% vs 28.1%) and routine discharge (68.4% vs 26.3%) compared with the nonburn group. Patients with necrotizing skin and soft-tissue infections and exfoliative skin conditions are older, have more comorbidities, higher complication rates, and higher mortality rates than burn patients. Given these findings, burn units may need to adjust their resource utilization, competencies, and research priorities to improve the quality of care being delivered to these two different populations.

The 'Celtic cross' technique for immediate umbilical reconstruction post-laparotomy and surgical ablation of the umbilicus.

SUMMARY: We present a novel method for immediate umbilical reconstruction following surgical ablation of the umbilicus that is simple and reproducible with aesthetically satisfactory results.

Abdominal computed tomography in the evaluation of acute and perforated appendicitis in the community setting.

Several studies report sensitivity and specificity of abdominal computed tomography scans (CT) for the evaluation of acute appendicitis as high as 98 per cent. Despite increased utilization of CT, the rate of negative appendectomy has remained constant at 10 to 20 per cent. The objective of this study was to assess the effectiveness of CT in the evaluation of acute and perforated appendicitis in an academic community-based setting. A retrospective review of 550 patient charts with International Classification of Diseases-9 (ICD-9) codes for acute and perforated appendicitis from January 2002 to October 2005 was performed. Sensitivity of CT was 87 per cent with a positive predictive value of 92 per cent. Specificity was 42 per cent with a negative predictive value of 29 per cent. Negative appendectomy rates were similar with or without CT (11% vs. 13%, respectively). Our data suggests that CT used liberally in everyday practice in a community-based setting to evaluate acute appendicitis may not have as strong of a diagnostic value as those used in protocol-driven research studies. Further prospective studies are needed to formulate criteria to better delineate the role of CT in the evaluation of acute appendicitis.

Evaluation of bronchoscopic-assisted percutaneous tracheostomy.

The convenience of bedside percutaneous tracheostomy (PT) is growing in popularity. Some centers are placing PTs without the assistance of bronchoscopy. The study objective was to identify operative and perioperative problems with PT placement and to identify potential problems with bronchoscopy-free placement. All operative and perioperative events were prospectively recorded as a performance improvement project at our institution while performing bronchoscopic-assisted bedside PTs. One hundred eighty-three patients underwent PT placement, all with the assistance of a bronchoscope. Although most PT was performed without incident, some of the complications can be severe. The majority of difficulties can be prevented with bronchoscopic assistance. An unexpected procedural difficulty that has not been previously reported is the dilatational difficulty in the younger patient population. Some of these patients required an additional tracheal incision with a scalpel. This may be from a healthy pretracheal fascia and/or musculature.