The Burden of Burns: An Analysis of Public Health Measures.

Accurate analysis of injuries is paramount when allocating resources for prevention, research, education, and legislation. As burn mortality has improved over recent decades, the societal burden of burn injuries has grown ambiguous to the public while a scarcity of investigational funding for survivors has led to a gap in understanding lifelong sequela. We aim to compare national references reporting the incidence of burn injuries in the United States. The American Burn Association Burn Injury Summary Report (ABA-BISR), American Burn Association Fact Sheet, Centers for Disease Control and Prevention (CDC) Web-based Injury Statistics Query and Reporting (WISQARS) database, the CDC National Center for Health Statistics' National Hospital Ambulatory Medical Care Survey (NHAMCS), National Inpatient Sample (NIS), National Emergency Department Sample (NEDS), and commercially available claims databases were queried for 2020 or the most recent data available. The BISR estimated 30,135 burn admissions in 2022. The 2016 ABA Fact Sheet reported 486,000 burns presented to US emergency departments (ED). In 2020, CDC's WISQARS database reported 3,529 fatal, and 287,926 non-fatal, burn injuries. The 2020 NEDS reported 438,185 ED visits while the 2020 NIS estimated 103,235 inpatients. The NHAMCS reported 359,000 ED visits for burn injuries in the same period, and an analysis of ICD-10 burn codes demonstrated over 698,555 claims. Our study demonstrates a large variability in the reported incidence of burn injury by the ABA, CDC, national samples, and claims databases. Per our analyses, we estimate that 600,000 individuals annually suffer a burn injury which merits emergent care in the United States.

Autologous Skin Cell Suspension for Full-Thickness Skin Defect Reconstruction: Current Evidence and Health Economic Expectations.

Despite differing etiologies, acute thermal burn injuries and full-thickness (FT) skin defects are associated with similar therapeutic challenges. When not amenable to primary or secondary closure, the conventional standard of care (SoC) treatment for these wound types is split-thickness skin grafting (STSG). This invasive procedure requires adequate availability of donor skin and is associated with donor site morbidity, high healthcare resource use (HCRU), and costs related to prolonged hospitalization. As such, treatment options that can facilitate effective healing and donor skin sparing have been highly anticipated. The RECELL® Autologous Cell Harvesting Device facilitates preparation of an autologous skin cell suspension (ASCS) for the treatment of acute thermal burns and FT skin defects. In initial clinical trials, the approach showed superior donor skin-sparing benefits and comparable wound healing to SoC STSG among patients with acute thermal burn injuries. These findings led to approval of RECELL for this indication by the US Food and Drug Administration (FDA) in 2018. Subsequent clinical evaluation in non-thermal FT skin wounds showed that RECELL, when used in combination with widely meshed STSG, provides donor skin-sparing advantages and comparable healing outcomes compared with SoC STSG. As a result, the device received FDA approval in June of 2023 for treatment of FT skin defects caused by traumatic avulsion or surgical excision or resection. Given that health economic advantages have been demonstrated for RECELL ± STSG versus STSG alone when used for burn therapy, it is prudent to examine similarities in the burn and FT skin defect treatment pathways to forecast the potential health economic advantages for RECELL when used in FT skin defects. This article discusses the parallels between the two indications, the clinical outcomes reported for RECELL, and the HCRU and cost benefits that may be anticipated with use of the device for non-thermal FT skin defects.

Iterative refinement of a histologic algorithm for burn depth categorization based on 798 consecutive burn wound biopsies.

INTRODUCTION: Our group previously reported a burn biopsy algorithm (BBA-V1) for categorizing burn wound depth. Here, we sought to promulgate a newer, simpler version of the BBA (BBA-V2). METHODS: Burn wounds undergoing excision underwent 4 mm biopsies procured every 25 cm2. Serial still photos were obtained at enrollment and at excision intraoperatively. Burn wounds assessed as likely to heal by 21 days were imaged within 72 h of injury and at 21 days. A sample of 798 burn wound biopsies were classified by both BBAV1 and BBAV2 algorithms. For nonoperative burn wounds, the proportion of healing versus nonhealing pixels at 21 days after injury were compared. RESULTS: The 798 biopsies were classified by BBAV1 as 24% SPT, 47% DPT, 28% FT and by BBAV2 as 3% SPT, 67% DPT, and 30% FT (p < 0.0001). Overall, the proportion of biopsies whose wound reclassification changed from a nonoperative to operative pathway was 21% (95% CI: 18-24%). Nonoperative wounds judged at injury as being SPT contained 12.8 million pixels. Repeat 21-day imaging revealed 11.3 million healed pixels (accuracy = 89.6% (95% CI: 89.59-89.62)). CONCLUSIONS: BBA-V2 was associated with a significantly higher concordance with visual assessment for burn wounds clinically judged as deep partial and full thickness.

Development of the national injury resource database (NIRD).

INTRODUCTION: Lack of an accurate, publicly available database of burn/trauma resources creates challenges in providing burn care. In response to this gap, our group developed the National Injury Resource Database (NIRD), a comprehensive database of all US burn centers (BC) and trauma centers (TC) and their capabilities. METHODS: Lists of all national BC and TC were obtained from the American Burn Association (ABA), the American College of Surgeons, and every state department of health. Data was cross-checked and included BC/TC were linked with a 7-digit identification number using the American Hospital Association Quick Search guide. Each center's resources and verification status were validated with electronic or telephonic communications. RESULTS: The final database includes 135 BC and 617 TC, of which 18 are BC-only, 500 are TC-only, and 117 are combined BC/TC. ABA-verified BC (n = 76) are only found in Washington DC and 31 states, and 8 states have no BC. In the last 10 years, a net increase of 7 burn centers was found nationally. The ABA's online BC directory is outdated. CONCLUSIONS: NIRD represents the only up-to-date, comprehensive listing of BC and TC in existence. It categorizes all currently operating BC and TC across myriad classifications of designation and capabilities.

Generating Team-Based Strategies to Reduce Health Inequity in Cancer Care.

PURPOSE/OBJECTIVES: Despite increased emphases on reducing racial disparities in the U.S. health care system, interprofessional care teams may inadvertently perpetuate health disparities through lack of awareness or experience in supporting individualized, patient-centered goals of care. Racial disparities can lead to health inequity. Persistent health disparity gaps exist among Black patients with multiple myeloma (MM) when compared with non-Black patients. Black patients experience a two-fold increase in MM risk and earlier age of onset compared with non-Black patients. Black patients are also less likely to receive timely access to some therapies, undergo autologous stem cell transplant, or enroll in clinical trials. This article describes a large-scale, equity-focused implementation science initiative aimed at identifying and overcoming racial disparities and health inequity among patients with MM through quality improvement goals identified by each of the interprofessional cancer care teams. PRIMARY PRACTICE SETTINGS: Interprofessional cancer care teams in two large oncology systems as well as four community clinics were engaged in this study along with their patients with MM. Geographic areas included the following: Chicago, IL; Washington, DC; Charlotte, NC; Columbus, OH; Denver, CO; and Indianapolis, IN. Interprofessional teams included hematologists/oncologists, primary care physicians, nurse practitioners/physician assistants, and case managers/nurse navigators. Teams collectively examined and compared their own beliefs and attitudes about their patients' goals for MM treatment and management versus those of their patients to uncover and address discordances. Medical records from the clinics were audited to evaluate disparities in treatment and practice at the point of care. Live, team-based audit-feedback sessions were implemented among teams to examine data sets, as well as utilize the data to address interprofessional factors that could enhance more equitable care. FINDINGS/CONCLUSIONS: Data from comparative surveys between patients and interprofessional team members revealed significant discordances that enabled health care teams to recognize gaps and identify ways to improve patient-centered care, such as shared decision-making. Through audit-feedback sessions, interprofessional teams were able to collaboratively meet and discuss methods to improve access to care coordination services and other strategies aimed at alleviating disparities. Baseline chart audits revealed and confirmed disparities of care including patient/disease characteristics, treatment history, clinical practice metrics, and patient-centered measures. Follow-up chart audits conducted 6 months later measured changes in documented practice behavior. Action plans developed by the interprofessional teams as a result of this study intend to address sustainable reductions in health disparities among patients with MM to improve health equity and overall care. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: This implementation science initiative and data results have several implications for case managers caring for diverse patients with MM in both large health systems and smaller community practices. Results punctuate the importance of identifying and supporting diverse patients' individualized goals and preferences in their care journey to mitigate health inequity and maximize health outcomes. The value of working collaboratively as an interprofessional team is evident in the study results, as is the role of the case manager in appropriate resource allocation to mitigate health disparities. Lessons learned from this initiative may also be applied to other case management settings where complex care delivery and interprofessional teams are at work.

Clinical Investigation of a Rapid Non-invasive Multispectral Imaging Device Utilizing an Artificial Intelligence Algorithm for Improved Burn Assessment.

Currently, the incorrect judgment of burn depth remains common even among experienced surgeons. Contributing to this problem are change in burn appearance throughout the first week requiring periodic evaluation until a confident diagnosis can be made. To overcome these issues, we investigated the feasibility of an artificial intelligence algorithm trained with multispectral images of burn injuries to predict burn depth rapidly and accurately, including burns of indeterminate depth. In a feasibility study, 406 multispectral images of burns were collected within 72 hours of injury and then serially for up to 7 days. Simultaneously, the subject's clinician indicated whether the burn was of indeterminate depth. The final depth of burned regions within images were agreed upon by a panel of burn practitioners using biopsies and 21-day healing assessments as reference standards. We compared three convolutional neural network architectures and an ensemble in their capability to automatically highlight areas of nonhealing burn regions within images. The top algorithm was the ensemble with 81% sensitivity, 100% specificity, and 97% positive predictive value (PPV). Its sensitivity and PPV were found to increase in a sigmoid shape during the first week postburn, with the inflection point at day 2.5. Additionally, when burns were labeled as indeterminate, the algorithm's sensitivity, specificity, PPV, and negative predictive value were: 70%, 100%, 97%, and 100%. These results suggest multispectral imaging combined with artificial intelligence is feasible for detecting nonhealing burn tissue and could play an important role in aiding the earlier diagnosis of indeterminate burns.

Development of Prepositioned Burn Care-specific Disaster Resources for a Burn Mass Casualty Incident.

Disaster preparedness for a burn mass casualty incident (BMCI) must consider the needs of the first responders and community hospitals, who may be the first to receive those patients. Developing a more comprehensive statewide burn disaster program includes meeting with regional healthcare coalitions (HCCs) to identify gaps in care. Quarterly HCC meetings, which link local hospitals, emergency medical services (EMS) agencies, and other interested parties, are held around the state. We rely on the HCC's regional meetings to serve as a platform for conducting focus group research to identify gaps specific to a BMCI and to inform strategy development. One of the deficiencies identified, particularly in rural areas that infrequently manage burn injuries, was a lack of burn-specific wound care dressings that could support the initial response. Relying on this process, a consensus was created for equipment types and quantities, including a kit for storage. Furthermore, maintenance, supply replacement, and scene delivery processes were developed for these kits that could augment a BMCI response. The feedback from the focus groups reminded us that many systems report having infrequent opportunities to provide care for patients with burn injuries. In addition, several types of burn-specific dressings are expensive. With the infrequent occurrence, EMS agencies and rural hospitals reported that it was doubtful their agency/hospital would have more than a minimal stock of burn injury supplies. Therefore, developing supply caches that can be quickly mobilized and deployed to the impacted area was one of the deficiencies we identified and addressed through this process.

Multisite Quality Improvement Initiative to Identify and Address Racial Disparities and Deficiencies in Delivering Equitable, Patient-Centered Care for Multiple Myeloma-Exploring the Differences between Academic and Community Oncology Centers.

Treatment of multiple myeloma (MM) is complex; however, with equal access to care, clinical outcomes for Black patients match those in other patient groups. To reveal and begin to address clinical practice barriers to equitable, patient-centered MM care, this quality improvement (QI) initiative assessed patient electronic medical records (EMRs) and surveyed patients and providers at two large hospital systems and four community-based practices. For the educational intervention, providers participated in feedback-focused grand rounds sessions to reflect on system barriers and develop action plans to improve MM care. EMR reviews revealed infrequent documentation of cytogenetics and disease staging at community-based practices compared to large hospital systems. In surveys, providers from each care setting reported different challenges in MM care. Notably, the goals of treatment for patients and providers aligned at community clinics while providers and patients from large hospital systems had discordant perspectives. However, providers in community settings underreported race-associated barriers to care and identified different factors impacting treatment decision-making than Black patients. Relative to pre-session responses, providers were more likely to report high confidence after the educational sessions in aligning treatment decisions with guidelines and clinical evidence and shared decision-making (SDM). This QI study identified discordant perceptions among providers at large hospital systems and community-based practices in providing quality MM care. Provider education yielded increased confidence in and commitment to patient-centered care.

Analysis of real-world length of stay data and costs associated with use of autologous skin cell suspension for the treatment of small burns in U.S. centers.

BACKGROUND: Autologous skin cell suspension (ASCS) is a treatment for acute thermal burn injuries associated with significantly lower donor skin requirements than conventional split-thickness skin grafts (STSG). Projections using the BEACON model suggest that among patients with small burns (total body surface area [TBSA]<20 %), use of ASCS± STSG leads to a shorter length of stay (LOS) in hospital and cost savings compared with use of STSG alone. This study evaluated whether data from real-world clinical practice corroborate these findings. MATERIALS AND METHODS: Electronic medical record data were collected from January 2019 through August 2020 from 500 healthcare facilities in the United States. Adult patients receiving inpatient treatment with ASCS± STSG for small burns were identified and matched to patients receiving STSG using baseline characteristics. LOS was assumed to cost $7554/day and to account for 70 % of overall costs. Mean LOS and costs were calculated for the ASCS± STSG and STSG cohorts. RESULTS: A total of 151 ASCS± STSG and 2243 STSG cases were identified; 63.0 % of patients were male and the average age was 44.2 years. Sixty-three matches were made between cohorts. LOS was 18.5 days with ASCS± STSG and 20.6 days with STSG (difference: 2.1 days [10.2 %]). This difference led to bed cost savings of $15,587.62 per ASCS± STSG patient. Overall cost savings with ASCS± STSG were $22,268.03 per patient. CONCLUSIONS: Analysis of real-world data shows that treatment of small burn injuries with ASCS± STSG provides reduced LOS and substantial cost savings compared with STSG, supporting the validity of the BEACON model projections.

A Risk-Benefit Review of Currently Used Dermal Substitutes for Burn Wounds.

While split-thickness autologous skin grafts remain the most common method of definitive burn wound closure, dermal substitutes have emerged as an attractive option. There are many advantages of utilizing a dermal substitute, notably reducing the need for donor tissue and subsequent iatrogenic creation of a secondary wound. However, there are disadvantages with each that most be weighed and factored into the decision. And most come at a high initial financial cost. There is little comparative literature of the various available and emerging products. This analysis was performed to objectively present risks and benefits of each option.

What Can State Medical Boards Do to Effectively Address Serious Ethical Violations?

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team's larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

Length of Stay and Costs with Autologous Skin Cell Suspension Versus Split-Thickness Skin Grafts: Burn Care Data from US Centers.

INTRODUCTION: Autologous skin cell suspension (ASCS) significantly reduces donor skin requirements versus conventional split-thickness skin grafts (STSG) for thermal burn treatment. In analyses using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model, ASCS was associated with shorter hospital length of stay (LOS) and cost savings versus STSG. This study hypothesized that daily practice data from the USA would support these findings. METHODS: Electronic medical record data from 500 healthcare facilities (January 2019-August 2020) were used to match adult patients who received inpatient burn treatment with ASCS (± STSG) to patients treated with STSG alone on the basis of sex, age, percent total body surface area (TBSA), and comorbidities. Based on BEACON analyses, LOS was assumed to represent 70% of total costs and used as a proxy to assess the data. Mean LOS, costs, and the incremental revenue associated with inpatient capacity changes were calculated. RESULTS: A total of 151 ASCS and 2443 STSG patients were identified: 63.0% were male and average age was 44.5 years. Eight-one matches were made between cohorts. LOS was 21.7 days with ASCS and 25.0 days with STSG alone (difference 3.3 days [13.2%]). LOS was lower with ASCS than STSG in four of five TBSA intervals. The LOS difference led to hospital bed cost savings of $25,864 per ASCS patient; overall cost savings were $36,949 per patient. Similar cost savings were observed in TBSA groupings < 20% and ≥ 20%. The reduced LOS with ASCS translated into an increased capacity of 2.2 inpatients/bed annually, which increased hospital revenue by $92,283/burn unit bed annually. CONCLUSIONS: Real-world data show that ASCS (± STSG) is associated with reduced LOS and cost savings versus STSG alone across all burn sizes, supporting the validity of the BEACON analyses. ASCS use may also increase patient capacity and throughput, leading to increased hospital revenue.

Autologous skin cell suspension (ASCS) is a treatment for thermal skin burn injuries that can be used alone or in combination with split-thickness skin grafts (STSG), the conventional standard of care. Projections using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model indicate that ASCS leads to shorter hospital length of stay (LOS) and overall cost savings compared with STSG alone. These model findings are supported by benchmarking study data from a limited sample of US burn centers. The current study aimed to understand whether the BEACON projections are supported by daily clinical practice data from US healthcare facilities. Using electronic medical record data, we matched patients who received ASCS ± STSG from January 2019 to August 2020 to those receiving STSG alone on the basis of demographic and clinical factors. Data analysis showed that hospital LOS was shorter (3.3 days) with ASCS ± STSG than STSG alone, a difference associated with a hospital bed cost savings of $25,864 per ASCS patient. Overall cost savings, which included nursing time and other costs, were $36,949 per patient. Analysis of patients with burns comprising total body surface areas less than 20% or at least 20% showed cost savings in both groups. The reduced LOS with ASCS also translated into the ability to treat 2.2 more patients per hospital bed per year, which was projected to increase hospital earnings. These real-world findings support those of modeling analyses, indicating that use of ASCS ± STSG is associated with meaningful clinical and economic benefits compared with use of STSG alone.

Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns.

OBJECTIVE: This analysis includes pooled safety data from 2 clinical trials (NCT01437852; NCT03005106) that evaluated the safety and efficacy of StrataGraft in patients with deep partial-thickness (DPT) burns. METHODS: The study enrolled 101 adult patients with thermal burns covering 3-49% of total body surface area. Patients were followed for up to 1 year. The pooled safety events included: adverse events (AEs), adverse reactions (ARs), serious AEs (SAEs), discontinuation, and deaths; immunological responses (reactivity to panel reactive antibodies [PRA] and human leukocyte antigen [HLA] class 1 alleles); and persistence of allogeneic DNA from StrataGraft. RESULTS: Eighty-seven (86.1%) patients experienced 397 AEs. Thirty patients (29.7%) experienced ARs; 16 patients (15.8%) experienced SAEs. The most frequent AEs were pruritus (n = 31; 30.7%), and blister, hypertension, and hypertrophic scar (n = 11 each; 10.9%); the most common AR was pruritus (n = 13; 12.9%). One patient discontinued the study; 2 patients experienced SAEs (unrelated to StrataGraft) leading to death. PRA and HLA allele reactivity was ≤ 25% at Month 3, with no persistent allogeneic DNA from StrataGraft. CONCLUSIONS: StrataGraft was well tolerated by patients, with a safety profile similar to autograft. StrataGraft may offer a safe alternative to autograft for DPT burns.

Bismuth/petroleum gauze plus high density polyethylene vs. bismuth/petroleum gauze: A comparison of donor site healing and patient comfort.

INTRODUCTION: Skin grafting continues to be a fundamental component of burn treatment and inherently, a donor site must be created and treated. Burn surgeons agree that specific dressings may have a significant affect on donor site healing, but we have no consensus as to which dressing provides maximum benefit. METHODS: Retrospective analysis of prospectively collected data from an observational, within-patient controlled assessment of a practice pattern intervention. The project compared donor sites treated with high-density polyethylene plus an overlying layer of bismuth/petroleum gauze to donor sites treated with bismuth/petroleum gauze alone. The primary endpoint was patient reported pain using a standard visual analog scale from 0 (no pain) to 10 (worst possible pain). A 2-point reduction in pain was considered clinically significant. Healing was defined as complete detachment of the dressings and> 95% wound re-epitheliazation. RESULTS: A total of 30 patients were observed and analyzed. Both dressings were associated with a mean pain rating of 6 out of 10 (STD= ± 2) and a median pain rating of 6 out of 10 (range = 0-10). Additionally, both dressings were associated with a mean healing time of 20 days (SEM=1.1). The subjective dressing preference showed that a majority of patients had no preference between the two modalities (n = 20). However, when an actual preference was stated (n = 10), bismuth/petroleum gauze alone was preferred by 9 out of 10 patients. CONCLUSION: Clinically and subjectively, we found no discernible differences between the 2 dressing regimens. Thus, bismuth/petroleum gauze alone is the more cost effective dressing choice. Our burn center continues to use bismuth/petroleum gauze alone as its standard of care for donor site dressings and will continue to try to define the optimal donor site dressing.

Evaluating Real-World National and Regional Trends in Definitive Closure in U.S. Burn Care: A Survey of U.S. Burn Centers.

To better understand trends in burn treatment patterns related to definitive closure, this study sought to benchmark real-world survey data with national data contained within the National Burn Repository version 8.0 (NBR v8.0) across key burn center practice patterns, resource utilization, and clinical outcomes. A survey, administered to a representative sample of U.S. burn surgeons, collected information across several domains: burn center characteristics, patient characteristics including number of patients and burn size and depth, aggregate number of procedures, resource use such as autograft procedure time and dressing changes, and costs. Survey findings were aggregated by key outcomes (number of procedures, costs) nationally and regionally. Aggregated burn center data were also compared to the NBR to identify trends relative to current treatment patterns. Benchmarking survey results against the NBR v8.0 demonstrated shifts in burn center patient mix, with more severe cases being seen in the inpatient setting and less severe burns moving to the outpatient setting. An overall reduction in the number of autograft procedures was observed compared to NBR v8.0, and time efficiencies improved as the intervention time per TBSA decreases as TBSA increases. Both nationally and regionally, an increase in costs was observed. The results suggest resource use estimates from NBR v8.0 may be higher than current practices, thus highlighting the importance of improved and timely NBR reporting and further research on burn center standard of care practices. This study demonstrates significant variations in burn center characteristics, practice patterns, and resource utilization, thus increasing our understanding of burn center operations and behavior.

Overcoming barriers to biosimilar adoption: real-world perspectives from a national payer and provider initiative.

In response to a published national payer survey indicating striking needs for multistakeholder initiatives to increase biosimilar adoption, a focus workgroup meeting joining payers and providers was conducted in December 2019 in Boston, MA. Before the focus group meeting, a survey was sent to health care providers to collect perceptions about barriers to biosimilar adoption and gather input on best potential strategies for addressing these barriers. The focus group panel consisted of 5 managed care pharmacists and 3 physician experts in rheumatology, dermatology, and gastroenterology, representing large managed care organizations and health care systems in the Boston area. A clinical moderator facilitated discussions between the payers and providers regarding challenges to biosimilar adoption and potential collaborative strategies to overcome these barriers. The focus group participants identified hurdles to biosimilar adoption in 3 major areas: (1) the lack of confidence in biosimilar interchangeability and a need for education about biosimilars, (2) the lack of financial incentives to switch to biosimilars from the reference biologic product, and (3) administrative burdens that impair the prescription of biologics. Learning from their mutual experiences, the focus group participants formulated action plans to address these barriers. The top strategies recommended by the participants included advancing biosimilar education, facilitating administrative processes related to biosimilar prescriptions, and increasing provider reimbursement while reducing cost sharing to patients receiving biosimilars. DISCLOSURES: The study reported on in this article was part of a continuing education program funded by an independent educational grant that was awarded by Sandoz Inc., a Novartis Division, to PRIME Education, LLC. The grantor had no role in the study design, execution, analysis, or reporting. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist with participant recruitment and content review for the continuing education program. Bandekar, Cheifetz, Edgar, Helfgott, Hoye-Simek, Liu, and Smith received an honorarium from PRIME for serving as faculty for the continuing education program. Cheifetz has received research grants from Inform Diagnostics and consulting fees from AbbVie, Bacainn, BMS, Grifols, Janssen, Pfizer, Prometheus, Samsung, and Takeda unrelated to this work. Smith has received consulting fees from Boehringer-Ingelheim, has served as an investigator on industry-initiated trials for AbbVie and Pfizer, and has served as an investigator on investigator-initiated trials for Novartis and Regeneron. Carter, Fajardo, and Simone have nothing to disclose.

Use of 816 Consecutive Burn Wound Biopsies to Inform a Histologic Algorithm for Burn Depth Categorization.

Burn experts are only 77% accurate when subjectively assessing burn depth, leaving almost a quarter of patients to undergo unnecessary surgery or conversely suffer a delay in treatment. To aid clinicians in burn depth assessment (BDA), new technologies are being studied with machine learning algorithms calibrated to histologic standards. Our group has iteratively created a theoretical burn biopsy algorithm (BBA) based on histologic analysis, and subsequently informed it with the largest burn wound biopsy repository in the literature. Here, we sought to report that process. This was an IRB-approved, prospective, multicenter study. A BBA was created a priori and refined in an iterative manner. Patients with burn wounds assessed by burn experts as requiring excision and autograft underwent 4 mm biopsies procured every 25 cm2. Serial still photos were obtained at enrollment and at excision intraoperatively. Burn biopsies were histologically assessed for presence/absence of epidermis, papillary dermis, reticular dermis, and proportion of necrotic adnexal structures by a dermatopathologist using H&E with whole slide scanning. First degree and superficial second degree were considered to be burn wounds likely to have healed without surgery, while deep second- and third-degree burns were considered unlikely to heal by 21 days. Biopsy pathology results were correlated with still photos by five burn experts for consensus of final burn depth diagnosis. Sixty-six subjects were enrolled with 117 wounds and 816 biopsies. The BBA was used to categorize subjects' wounds into four categories: 7% of burns were categorized as first degree, 13% as superficial second degree, 43% as deep second degree, and 37% as third degree. Therefore, 20% of burn wounds were incorrectly judged as needing excision and grafting by the clinical team as per the BBA. As H&E is unable to assess the viability of papillary and reticular dermis, with time our team came to appreciate the greater importance of adnexal structure necrosis over dermal appearance in assessing healing potential. Our study demonstrates that a BBA with objective histologic criteria can be used to categorize BDA with clinical misclassification rates consistent with past literature. This study serves as the largest analysis of burn biopsies by modern day burn experts and the first to define histologic parameters for BDA.