Total Body Surface Area Research Articles

Donor site healing response to low-level laser therapy following skin graft surgery

IntroductionSkin grafting is an essential reconstructive technique for the healing of deep and extensive burns. Donor site problems are common complications after skin graft surgery. Speeding up the healing process at the donor site using low-level laser therapy helps avoid these problems. Objectives: The purpose of this research was to examine the efficacy of low-level laser therapy in promoting donor site healing in burn patients who underwent skin graft surgery.MethodsForty patients of both genders (16 male, 24 female) aged 20–40 years suffered full-thickness burns with a total body surface area varying from 20 to 35% and had undergone split-thickness skin graft surgery were selected randomly and divided into two equal groups. The low-level laser therapy group (study group) attended three sessions per week for three weeks, while the placebo group (control group) received sham laser treatments. All patients received conventional medical treatment and traditional wound care (dressing). Photography and J Image software were used to measure wound surface area before the treatment (day 1 post-operative), day 11 post-operative, and day 21 post-operative in both groups.ResultsThe study and control groups demonstrated a substantial reduction in wound surface area at day 11 and day 21 post-operative compared with day 1 (<i>p</i> < 0.001), with the percentage of improvement of 88.69% and 98.73% and 50.18% and 80.22%, respectively. On day 21 compared to day 11 (<i>p</i> < 0.001), the percentage of improvement was 88.81% and 60.30%, respectively. Between-group comparisons revealed a significant decrease in wound surface area at day 11 and day 21 post-operative in the study group compared to the control group (<i>p</i> < 0.001).ConclusionsLow-level laser therapy is an effective modality for enhancing wound healing of the donor site in burned patients undergoing skin graft surgery.

A retrospective study to assess the effectiveness of bath in burns healing by reducing the Length of Stay in hospital at Apollo Speciality Hospital, Vanagaram

Background: Ours is a dedicated burns unit at Apollo Speciality Hospitals, Vanagaram. This study deals with two mass casualties at Neyveli Lignite Corporation (NLC) and Pharmaceutical company (Pondicherry). This came to initiate the quick recovery of the patient of the hospital stay. Methods: Retrospective cohort study research design was taken for this study. The study was conducted at Apollo Speciality Hospitals, Vanagaram for a duration of 3 months, 60 samples using simple random sampling who met the inclusion criteria were selected as study samples. Data collection tool such as Socio- Demographic Data (Age in years, Sex, Average Length Of Stay, Scar sites) and clinical variables proforma of cleansing modality, cleansing solution, additives, frequency were used. Result: Percentage of total body surface area will reflect in Average Length Of Stay. 33 responders were given the bathroom bath was discharged with 11-20 days of hospital stay. 4 responders of bathroom bath were discharged with 21-30 days of hospital stay. In this study the estimation of hospital Length Of Stay was calculated as 1 day per percent total body surface area burn (1 day/%TBSA) by improving the wound healing by giving bathroom bath. Conclusion: Wound cleansing and dressing is the basic procedure where the wound healing begins.

Assessing the generalizability of a National Burn Database to the United States pediatric burn injury population.

A national database is used to evaluate pediatric burn survivor outcomes, but the generalizability to the United States pediatric burn injury population is unclear, as only 60% of enrollees are U.S. residents. An increased understanding of population similarities and differences between residents of the United States and residents of Mexico treated in the United States within this database will help determine its ability to extrapolate. Assess the generalizability of a national burn database to the U.S. pediatric burn injury population. This retrospective cohort study analyzed pediatric enrollees in a burn database. Data were stratified into children who were residents of the United States or Mexico at time of injury and grouped by age into <5 years, 5-10 years, and >10 years. Not applicable. A total of 2043 children enrolled in the database from 1998 to 2020. Not applicable. Determination of similarities and differences between gender, injury etiology, total body surface area injured, length of stay, and place of injury between the two groups. Both groups showed an increased incidence of burn injury among males as they aged. In U.S.residents, the most frequent etiology in patients <5 years was scald (292 [53.6%]), followed by fire/flame (157 [28.8%]). In residents of Mexico, fire/flame burns were more frequent in all ages and electric burns were more common among children >5 years. In both groups, outdoor injuries became more common as children aged. Children from Mexico had larger burns and longer lengths of hospital stay than children from the United States across all ages. Differences between U.S. and Mexico groups were likely attributable to children with more severe burns being transferred to the United States for care, whereas those with low-severity burns were treated locally. This suggests that children from Mexico in the database were not representative of the pediatric burn injury population of the United States or Mexico more broadly and caution should be used before generalizations are made using this database.

Clinical Profile and Outcome of Burn Injuries amongst Children in a Tertiary Care Center of North India

Objectives: The study aims to describe the clinical characteristics and outcome of pediatric burn patients admitted to a tertiary care hospital. Patients and methods: This was a cross-sectional, retrospective study that reviewed the records of all burn victims aged 0 to 12 who were admitted in a tertiary care hospital in North India over one year. Collected data included patient demographics such as age, gender, burn causal agents, discharge time, Total body surface area (TBSA) burnt by using Lund and Brauder’s Rule, the duration of stay, the season and month of admission that burn occurred, and burn characteristics, such as region of body involved, percentage of area burnt, complications and outcome. Results: 129 paediatric burn patients under 12 were included with median age of 4 years. Scald caused the majority of burns (81.4%), followed by dry burns (14.7%) and electric injuries (3.9%). The Median burn percentage was 20 and most burn patients were encountered during the winter season. The face and neck (56.6%) were involved in majority of cases, with a 4.6% overall mortality rate. Conclusion: This retrospective study provides valuable insights into the clinical profile of burn patients admitted to a tertiary care center in North India. The study's findings can help guide the development of targeted interventions and resource allocation to improve burn care in this region, ultimately reducing morbidity and mortality among burn patients.

Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time: Results from the EFFISAYIL® 2 trial

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the effects on GPP body surface area (BSA) over time in patients treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Total BSA improved continuously under spesolimab treatment (13.3% at baseline, 10.6% at Week 4, 9.4% at Week 16, ending at 4.5% at Week 48). Continuous treatment with spesolimab SC improved BSA from 13% to 5% at the end of the trial. These findings suggest a role of spesolimab in improving area of involvement as measured by BSA.

Analysis of Burn Casualties in the Swords of Iron War

Abstract The Swords of Iron (SOI) War is an armed conflict between Israel and Hamas, which has been taking place in Gaza from October 2023 until the present time of writing this article. This war is characterized by urban close contact combat. The combat equipment, weaponry, and protective measures employed, differ markedly from those in previously documented major conflicts, significantly impacting the types of injuries sustained by soldiers. This study examines the number of injured soldiers in combat, field mortality rates, incidence of burns and trauma, demographic details of the injured, causes and distribution of injuries, burn characteristics, hemodynamic status, and injury severity. This is a retrospective, registry-based cohort study. Military personnel treated by IDF medical teams with burn injuries from the ground maneuver in Gaza between October 27th, 2023 to April 2024 were included in the analysis. Diagnosis of burn injuries was made in the prehospital setting and recorded in the patient’s casualty cards and the IDF trauma registry and/or in the hospitals, and then recorded by the Israel National Trauma Registry. A total of 2,627 documented military personnel were included. Of them, there was a total of 249 burn casualties. They were all male combat soldiers and their mean age was 22 years. Most of the burn injuries were combined with other injuries, only 12% were defined as in shock state, and 14% received whole blood in the field. The burn degree was second and third degree for most cases. A third (34%) of burn injured soldiers had surgery (Table 2), and half of the total were sent to rehabilitation departments following their initial hospitalization. An analysis of total body surface area (TBSA)% affected by burns among SOI War casualties reveals a higher proportion of severe burns exceeding 20% TBSA, compared to previous conflicts. Additionally, a higher proportion of personnel suffered from second and third degree burns. This is likely attributed to the operational mode of the IDF in Gaza, where urban close-contact warfare exposes soldiers to heightened risks of explosive and blast injuries. A significant percentage of live casualties had TBSA percentages that were not life-threatening, which underscores the importance of updating emergency burn treatment protocols and employing rapid evacuation and medical response systems in the field. Most of the wounded that suffer from significant burns had other significant and life-threatening injuries, making the appropriate protective measures and the preparation for rapid evacuation the best way to improve burn casualty survival. The significance of this research lies in the timely analysis of accumulated combat data to derive lessons and conclusions relevant to ongoing and future conflicts, and to understand the clinical implications arising from combat situations. Given the relatively high prevalence of burn injuries, understanding their etiology, severity, and consequences is essential for developing effective prevention and treatment courses.

Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the effects on GPP body surface area (BSA) over time in patients switched from a small-molecule systemic therapy at randomization when treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Within the FDA approved spesolimab regimen group, the average BSA for patients who stopped a systemic medication for GPP (Total N=22; acitretin = 13, cyclosporine = 7, methotrexate = 1, acitretin/methotrexate = 1) was 11.1 at baseline, decreasing to 8.2 at Week 4, 6.4 at Week 16, and then ending at 3.6 at Week 48. Total BSA involvement decreased over the 48 weeks of the trial in spesolimab-treated patients who stopped an off-label systemic medication for GPP at randomization.

Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: Results from the EFFISAYIL® 2 trial

Generalized pustular psoriasis (GPP) is a chronic inflammatory, potentially life-threatening skin disease. Most patients experience chronic skin symptoms between flares which can lead to significant patient burden. Spesolimab, an anti-interleukin-36 receptor monoclonal antibody, is approved in the United States to treat GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. EFFISAYIL® 2 (NCT04399837) evaluated the efficacy and safety of subcutaneous (SC) spesolimab in GPP. Here, we report the effects on GPP body surface area (BSA) over time in patients diagnosed &lt;5 vs ≥5 years prior to enrollment when treated with the FDA approved spesolimab dosing regimen (600 mg loading dose, then 300 mg maintenance dose every 4 weeks) in EFFISAYIL® 2. Total BSA was determined based on a weighted average of the extent of involvement over 4 main body regions, with head = 10%, upper extremities = 20%, trunk = 30%, and lower extremities = 40%. Total BSA involvement was calculated for each subject at 4 timepoints (baseline, Week 4, Week 16, and Week 48). Data collected closest to the given time points were used by including the effect of potential intravenous spesolimab treatment and subsequent open-label SC spesolimab treatment in patients who experienced a flare. The data were analyzed as observed. Within the FDA approved regimen spesolimab group, average BSA for patients diagnosed with GPP for &lt;5 years (N=13) was 14.7 at baseline, 15.0 at Week 4, then decreasing to 11.7 at Week 16, and then to 5.0 at Week 48. For patients diagnosed with GPP for ≥ 5 years (N=17) the values were 12.3 at baseline, decreasing to 7.0 at Week 4, increasing slightly to 7.6 at Week 16, and decreasing to 4.1 at Week 48. Total BSA involvement decreased over the 48 weeks of the trial in spesolimab-treated patients regardless of whether they were early (&lt; 5 years) or late (≥ 5 years) in their disease course. This finding demonstrates the efficacy of spesolimab in controlling GPP consistently for patients with various lengths of disease history.

Efficacy of Deucravacitinib in Plaque Psoriasis Across a Range of Body Surface Area Involvement: Post hoc Analysis of the Randomized, Double-Blinded, Placebo-Controlled, Phase 3b/4 PSORIATYK SCALP Trial

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Scalp involvement affects approximately 80% of patients with plaque psoriasis. PSORIATYK SCALP (NCT05478499) is an ongoing, 52-week, multicenter, phase 3b/4 trial evaluating deucravacitinib in patients with moderate to severe scalp psoriasis, including those with a range of total body surface area (BSA) involvement (≥3%). These patients are candidates for systemic therapy, according to the AAD/NPF and IPC treatment guidelines. This post hoc analysis assessed efficacy in overall body psoriasis. Methods: Adults (age ≥18 years) with moderate to severe scalp psoriasis (scalp-specific Physician Global Assessment [PGA] ≥3, scalp surface area involvement ≥20%, and Psoriasis Scalp Severity Index ≥12 at baseline) and BSA involvement ≥3% were eligible for inclusion. Patients were randomized 1:2 to oral placebo (n=51) or deucravacitinib 6 mg once daily (n=103) through Week 16. Stratification factors included prior biologic use and body weight. Outcomes at Week 16 included static PGA score of 0 (clear) or 1 (almost clear) (sPGA 0/1), change from baseline in Psoriasis Area and Severity Index (PASI), and change from baseline in whole-body itch numeric rating scale (NRS). Nonresponder imputation (binary outcomes) and modified baseline observation carried forward (continuous outcomes) were used for patients with missing data. All P values are nominal. Results: Baseline characteristics were similar between groups (deucravacitinib: mean [SD], BSA 10.5% [9.6%], PASI 10.2 [6.7], whole-body itch NRS 5.8 [2.8]; placebo: mean [SD], BSA 10.0% [8.1%], PASI 9.4 [5.6], whole-body itch NRS 5.8 [2.4]). Baseline total BSA involvement was 3%-10% in most patients (deucravacitinib, 68.0%; placebo, 74.5%). At Week 16, a significantly higher proportion of patients receiving deucravacitinib versus placebo achieved sPGA 0/1 (47.6% [95% CI, 37.6%-57.6%] vs 3.9% [0.5%-13.5%], respectively; P&lt;0.0001). Similarly, patients treated with deucravacitinib achieved greater decreases in adjusted mean change from baseline in PASI (−6.4 [95% CI, −7.3 to −5.5] vs −1.3 [−2.6 to −0.1]; P&lt;0.0001) and whole-body itch NRS (−2.9 [−3.4 to −2.4] vs −0.4 [−1.1 to 0.3]; P&lt;0.0001). Conclusion: In the phase 3b/4 PSORIATYK SCALP trial, deucravacitinib was efficacious in improving overall psoriasis. Efficacy was consistent with the results observed in the phase 3 POETYK PSO-1/PSO-2 trials, despite including patients with less extensive total BSA involvement.

Predicting Mortality in Severe Burns: A Comparison of Four Mortality Prediction Scores and the Role of Organizational Changes in the Croatian Burn Center

Background: The primary aim of this study was to evaluate the performance of four burn prognostic scores—Abbreviated Burn Severity Index (ABSI), Ryan, Belgium Outcome Burn Injury (BOBI), and revised Baux score (rBaux) in a Croatian burn center. A secondary aim was to compare patient outcomes before and after the organizational and protocol changes. Methods: A retrospective study and comparison of four prediction scores was conducted over a nine-year period in burn patients with ≥20% total body surface area (TBSA) burned. Additionally, outcomes before and after organizational changes were compared. Results: A total of 149 patients were included, with the mean patient age of 54.62 ± 19.38 years, the mean of TBSA of 42.98 ± 19.90, and an overall mortality rate of 48.99%. The area under the ROC curve (AUROC) was 0.79 for the rBaux and ABSI score, 0.77 for the BOBI score, and 0.76 for the Ryan score. The duration of mechanical ventilation and length of stay (LOS) in burn intensive care units (BICU) decreased after the organizational changes, though survival rates remained similar. Conclusions: Prognostic scores are good predictors of mortality but with moderate predictive accuracy. Continuity of care in intensive care could be important for better outcomes.

Quality of Life Assessment Four Years after a More than Ninety Percent Total Body Surface Area in Two Survivors with Burns: Case Report.

There are few reports in the literature detailing the Quality of Life (QOL) of survivors with greater than 90% total body surface area (TBSA) burns. The objective was to assess two such individuals seen at our center with the Burn Specific Health Scale-Brief (BSHS-B) survey four years after discharge. Subject responses were categorized into their respective BSHS-B health domains (heat sensitivity, affect, hand function, treatment regimens, work, sexuality, interpersonal relationships, simple abilities, and body image) and a raw score was calculated for each domain. Lower scores indicated a greater perceived decrease in QOL. The nine domains of BSHS-B survey questions were further separated into three categories: physical (hand function, work, simple abilities), treatment (treatment regimens and heat sensitivity), and psychosocial (interpersonal relationships, affect, body image, sexuality). The psychosocial category had higher scores and better outcomes, while the physical and treatment ones had lower scores and worse outcomes compared to the other categories. For both individuals, interpersonal relationships and simple tasks domains were considered important in their QOL, while work, heat sensitivity and hand function received lower scores. Family support, intense physical rehabilitation, and psychosocial management were crucial during the postoperative and follow-up periods.

Management considerations in grease versus non-grease scald burns in adults: A retrospective cohort study at a tertiary burn care facility

IntroductionScald burns are challenging to manage due to their evolutionary nature and nuanced injury pattern. Different mediums, such as hot water, steam, or grease, each have unique physical properties that may inflict more damage and incite a different inflammatory response. While pediatric patients are often the focus of scald burn research, a significant number of adults still suffer from scald burns, especially while cooking with hot grease. Our study aimed to analyze differences in injury pattern and management between grease versus non-grease scald burns. Materials and MethodsA retrospective chart review was done on all scald burn patients at a tertiary burn care center from January 2020 to December 2022. The primary outcomes were admission and length of stay with the primary exposure being grease versus non-grease scald burns. Secondary outcomes included rates of surgical excision and changes in surgical management plans. Multivariate regressions were employed to control for sex, age, total body surface area (TBSA), and burn thickness. ResultsOf 165 patients with scald burns, 41 out of 91 (45.1 %) with grease burns and 43 out of 74 (58.1 %) with non-grease burns were admitted. No statistically significant difference in length of hospital stay existed between admitted grease and non-grease burns (p = 0.45). Additionally, no differences were observed for surgical excision (p = 0.63) and changes in surgical management plans (p = 0.47) ConclusionThe mechanism of scald burn caused by either a grease or non-grease source is not associated with any differences in admission, length of hospital stay, or surgical management. Scald burn management should still focus on patient age, TBSA, and burn thickness regardless of the causative agent.

Risk Factors for ARDS in Hospitalized Burn Patients: An Analysis of the National Trauma Data Bank.

Acute Respiratory Distress Syndrome (ARDS) is a common complication among mechanically ventilated adult burn patients; however, the risk factors associated with its development are not well understood. Conflicting evidence also exists regarding ARDS as an independent predictor of poor hospital outcomes. The purpose of this study is to identify risk factors for ARDS in mechanically ventilated adult burn patients and characterize the impact of ARDS on hospital course. The National Trauma Data Bank (NTDB) was queried for patients >=18 years with International Classification of Diseases (ICD) codes corresponding to burn injury from 2007-2016. Hospitalized patients with at least 48 hours of mechanical ventilation were included. Multivariate logistic regression were used to identify risk factors for ARDS. Propensity score-matched analysis at a 1:3 ratio was used to determine the impact of ARDS on hospital course. This sample included 13928 patients, of which 1437 (10.3%) developed ARDS. Hypotension in the Emergency Department, alcohol use disorder, total body surface area (TBSA), Injury Severity Score (ISS), and inhalation injury were independently associated with ARDS. In the propensity score-matched cohort, ARDS patients had a significantly longer median (interquartile range) length of stay (31 [15-54] vs. 22 [9-43], p<0.001). In-hospital mortality was also significantly higher in the ARDS cohort (203 [35%] vs. 325 [24%], p<0.001). These findings highlight the impact of patient and injury characteristics on developing ARDS and support the consideration of ARDS when estimating mortality risk in burn patients.

Identification and quantification of physical activity in critically ill burn patients: a feasibility study

BackgroundPhysical activity is essential in burn care to counteract the effects of severe burns and inactivity during hospitalization. However, detailed knowledge of performed physical activities is lacking. This study evaluated the feasibility of a dual accelerometer-based method to assess type, frequency, and duration of physical activity in critically ill burn patients during hospitalization. MethodsA prospective observational study was conducted at the burn center of the Martini Hospital, Groningen, The Netherlands. Eligible were patients with a total body surface area (TBSA) burned of ≥15% or an indication for intensive care. Patients wore two accelerometers, one on the chest and one on the diagonally opposite thigh. An algorithm converted accelerometer data into type, frequency, and duration of activities common for intensive care patients. An activity diary was used to assess non-wear time and its content, e.g., surgery. ResultsFive patients (20-60 years, 13-31% TBSA burned, LOS 30-65 days) were included. Per patient, 14-49 days (17380-61796min) could be analyzed of which 7%-14% was non-wear time. During wear-time, 86-95% of activities could be identified and quantified. However, processing the data was a labor-intensive process. ConclusionThe dual accelerometer-based method proved feasible for research purposes. For clinical application, further refinement of data-processing is required.

Burns injury characteristics and outcomes at lautoka hospital, fiji

BackgroundBurns injury are a global public health problem and one of the leading causes of morbidity and mortality. However, there is no published literature available from Lautoka Hospital in Fiji that assessed the characteristics and outcomes of burn patients. ObjectiveThe aim of this study was to explore sociodemographic and clinical characteristics, medical care and outcomes of burn injury patient at Lautoka Hospital in order to gain deeper insights into burns related issues and improve burns care at the hospital. MethodA retrospective cross-sectional study was conducted between January 1st 2020 and June 30th 2024 at Lautoka Hospital in Fiji. Data were analysed using SPSS version 25. The association between independent variables and outcomes was assessed using Chi-square test. ResultsStudy population included 267 patients predominately male (57 %). Majority of the patients (59 %) were aged below 10 years. Most of the burns occurred at home (92 %). A significant proportion of patients (64 %) had burns affecting multiple regions with the lower extremities being the most commonly affected area. Partial thickness burns were observed in 87.5 % of patients. The majority of patients (55 %) had a total body surface area (TBSA) < 10 % affected by burns. Normal saline (39 %) and Paracetamol (93 %) were most commonly used intravenous fluid and analgesic respectively. Most patients (93.5 %) underwent daily hydrotherapy while 26 % required surgical interventions. The median length of hospitalisation was 7.4 days. Wound infection occurred in 25 % of patients and the mortality rate was 10 %. ConclusionThis study provides deeper insights into burn related issues in order to reduce the incidence and morbidity of burn injury, and improve care. This study is single centred and conducted retrospectively thus limiting exploration of additional associations. A multicentred prospective study is recommended.

Prediction of First-in-Human Dose of Chimeric Antigen Receptor-T (CAR-T) Cells from Mice.

In this study, six scaling methods were evaluated for the prediction of FIH dose for CAR-T cells. The methods were body weight-based fixed exponents such as 1.0 and 0.75, human equivalent dose (HED) using exponents 0.33, two modified HED methods such as using total animal dose (in place of per kg basis) and body surface area in place of body weight using total animal dose with exponent 0.33 and a physiological factor derived from physiological parameters. The FIH doses of six CAR-T cells were predicted in this study. The predicted human doses were compared with the recommended human dose by the US-FDA for four CAR-T cell products, and the literature data were used for the remaining two CAR-T cells. The results indicated that the two modified HED methods and physiological factor are the best and reliable methods for the prediction of FIH dose for CAR-T cells. The proposed methods are simple and accurate in their predictive power and can be used on a spreadsheet.

Ultrasound Assessment of Pleural Effusions After Orthotopic Pig‐to‐Baboon Cardiac Xenotransplantation

ABSTRACTBackgroundPleural effusions develop frequently after cardiac surgery in humans. Lung ultrasound is an essential non‐invasive tool in the diagnosis and treatment of these effusions. Pleural effusions also develop regularly after preclinical cardiac xenotransplantation experiments. Unlike in the human setting, modern ultrasound devices lack pre‐installed tools for calculating the volume of pleural effusions in baboons. The aim of this study was to analyze ultrasound examinations of pleural effusions after orthotopic pig‐to‐baboon cardiac xenotransplantation experiments in order to develop a formula for calculating the effusion volume based on ultrasound measurements.MethodsHearts from seven genetically modified (GGTA1‐KO, hCD46/hTBM transgenic) juvenile pigs were orthotopically transplanted into male baboons. Postoperatively, the baboons were tested regularly for the development of pleural effusions using ultrasound. When thoracocentesis was required, the drained effusion volume (EV) was compared to ultrasound‐derived calculations using various formulas. These calculations were based on measuring the distance between lung and diaphragm at the effusions’ maximum height (Hmax). Subsequently, the most promising formula was used to describe the interobserver variability between trained and untrained staff members to predict effusion volumes based on ultrasound measurements.ResultsUltrasound measurement correlated very strongly with the absolute EV (r = 0.9156, p &lt; 0.0001), with EV indexed to total body weight (r = 0.9344, p &lt; 0.0001) and with EV indexed to body surface area (BSA) (r = 0.9394, p &lt; 0.0001). The ratio between Hmax and EV increased with total body weight and BSA and also depended on the baboon species. The sonographic measurements taken by an experienced and an inexperienced observer showed only low interobserver variability. A Bland–Altman plot of both observers’ measurements showed an overall bias of –2.39%.ConclusionUltrasound imaging provides a simple and non‐invasive tool for measuring pleural effusion quantity in baboons. This facilitates simple and efficient monitoring even in the hands of untrained personnel and may guide the decision‐making to perform thoracocentesis.

A pRospective, historical-controlled Evaluation of oLIceridine for moderate or sEVEre pain in patients with acute burn injuries (RELIEVE)

Oliceridine, a biased, selective opioid agonist, has shown a 3-fold preferential activation of the G-protein (i.e., analgesia) over β-arrestin pathway. β-arrestin activation is believed to be associated with higher adverse events, such as constipation, respiratory depression, and desensitization. There is no literature of use in patients with burn injuries. We hypothesized the use of oliceridine would provide adequate and safe analgesia after acute burn injury. Ten patients received oliceridine as their sole opioid for up to 7 days, which was compared to a random, historical cohort receiving standard of care (i.e, fentanyl, oxycodone, hydromorphone, and morphine). The historical control group was initially matched 2:1 (though 2 patients were ultimately excluded) with the oliceridine group according to age, percent total body surface area burned (TBSA), and number of operations. No patient had a history of known opioid, cocaine, or methamphetamine use, as this was an exclusion criterion for the prospectively-enrolled group. Baseline numerical rating scale (NRS) was similar for both groups [9 (7.8, 10) vs 9.5 (8.8, 10); p = 0.360). Over the 7-day period, mean daily pain scores significantly decreased in both groups. However, use of oliceridine was associated with a significantly larger decrease in mean pain score [-0.74 (-1.36, -0.12), p = 0.0215]. There was no difference in average daily morphine milligram equivalents (MME) [-14.02 (-67.22, 39.19), p = 0.5939]. There were no unexpected adverse events related to oliceridine. Oliceridine demonstrated significant pain relief, which was maintained over the 7-day study period. The control group demonstrated initial relief, but was not maintained despite similar MME.

Continuous peripheral nerve blocks for burn management: a retrospective study of outcomes and complications in 281 burn patients.

There is scarce literature regarding the use of continuous peripheral nerve blocks in acute burn patients, who may be at higher risk for catheter-related complications, including infection. We sought to describe our center's experience and infection rate with continuous perineural catheters in the setting of pain management for patients suffering from burns. A retrospective observational study was performed including all patients admitted to an American Burn Association-verified regional burn center between January 2018 and July 2023 who received a continuous peripheral nerve block for an acute burn injury. There were 281 patients in the study cohort who received 484 perineural catheters. The cohort was 52% men with a median age of 39 years (IQR 30-55). A catheter-associated infection, defined as a clinical diagnosis by the treating physicians requiring the need for treatment with antibiotics or surgical debridement, was identified in six perineural catheters (1.2%, 95% CI 0% to 2.2%) involving six different patients (2.1%, 95% CI 0% to 3.8%). The median total body surface area burned was 5% (IQR 2-9%) and 20% of patients had full-thickness burns. The most commonly used catheters were infraclavicular (49%), popliteal sciatic (29%), femoral (19%), and adductor canal (17%). One-third (33%) of patients did not require operating room debridement as the block provided sufficient analgesia for bedside debridement. The median duration of catheter use was 6 days (IQR 4-8). There were no documented cases of nerve injury or toxicity, vascular injury, or local anesthetic systemic toxicity. In our practice, continuous perineural catheters in the setting of acute burns are associated with an infection rate comparable to other surgical populations.

Cyclosporin for the treatment of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN): a systematic review of observational studies and clinical trials focusing on single therapy, combination therapy, and comparative assessments.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare, severe, and potentially life-threatening skin and mucous membrane disorders. They are characterized by widespread skin and mucosal detachment and necrosis, and are classified based on the percentage of total body surface area (TBSA) affected. Given the severe and often life-threatening nature of these conditions, the identification and implementation of effective treatments is crucial. Notably, cyclosporin has demonstrated efficacy in managing these challenging conditions. A systematic search was carried out through the PubMed, Scopus, Embase, Web of Science, and Cochrane Library databases until May 2024. Additionally, a manual search was conducted through the reference lists of the included studies to minimize the risk of missing reports. Overall, 17 studies involving 4761 patients were included in our analysis. The majority of the included studies suggested favorable outcomes for the use of cyclosporin in SJS/TEN patients. The use of cyclosporin was associated with improved survival rates, early arrest of disease progression, faster re-epithelialization, reduced length of hospital stays, and lower rates of multi-organ failure. However, a few studies did not find a survival advantage with cyclosporin and even reported an increased risk of mortality, as well as an increased TBSA detachment and risk of infection. Most studies indicate positive outcomes with cyclosporin treatment in SJS/TEN patients. This is likely due to cyclosporin's immunomodulatory properties, which may help attenuate the severe inflammatory response associated with these conditions.