Vol 42 Iss S1 April 2021 Vol Vol 42 | Iss S1 | April | 2021 Abstracts Top Six Abstracts T2 One Year Follow up Results of the DETECT Enzymatic Debridement Multicenter RCT T1 Initial Results of the American Burn Association (ABA) Multi-Center Evaluation William L. Hickerson, MD, Jeremy Goverman, MD, on the Effectiveness of the Burn Navigator Sigrid A. Blome-Eberwein, MD, Adam Singer, MD, Lucy Wibbenmeyer, MD, Nicholas Meyer, MD, Julie A. Rizzo, MD FACS, Maria L. Serio-Melvin, Joshua S. Carson, MD, FACS, James Gallagher, MD, MSN RN, Elsa Coates, MS, RN, CCRN, FACS, Steven Kahn, MD, Dhaval Bhavsar, MBBS, Nehemiah T. Liu, MS, Jose Salinas, PhD David Mozingo, MD, Tam N. Pham, MD, FACS, United States Army Institute of Surgical Research, Nicole S. Gibran, MD, FACS, Jeffrey W. Shupp, Fort Sam Houston, Texas MD, FACS, Kevin N. Foster, MD, MBA, FACS, Giavonni M. Lewis, MD, FACS, Julie Caffrey, DO, Introduction: The Burn Navigator (BN) is an FDA-cleared MS, FACOS, Yaron Shoham, MD clinical decision support tool used to aid fluid resuscitation Firefighters’ Regional Burn Center, Memphis, Tennes- after major burn injury. The BN provides users with hourly see; Massachusetts General Hospital, Boston, Massa- recommendations for fluid titration during the initial resus- chusetts; LVHN, Allentown, Pennsylvania; Renais- citation based on various factors. The objective of this multi- sance School of Medicine at Stony Brook University, center observational study was to evaluate the resuscitation Stony Brook, New York; University of Iowa Hospitals volumes and related outcomes of patients admitted to five & Clinics, Iowa City, Iowa; Columbia-St. Mary’s ABA verified burn centers who underwent intravenous fluid Milwaukee Campus, Milwaukee, Wisconsin; UF resuscitation utilizing the BN. Shands Burn Center, GAINESVILLE, Florida; New Methods: Data was collected from 300 patients who were York-Presbyterian/Weill Cornell Medicine, New York, resuscitated utilizing the BN. Two analyses were performed: New York; Medical University of South Carolina, examination of the first 24 hours of resuscitation after burn Charleston, South Carolina; The University of Kansas injury and examination of 24 hours of resuscitation using the Health System, Kansas City, Kansas; University of BN, regardless of when the resuscitation began, to account Florida College of Medicine, Gainesville, Florida; for patients who presented in a delayed fashion. Patients were University of Washington Regional Burn Center, classified as having followed the BN device if all hourly fluid Seattle, Washington; University of Washington, Se- rates were within 40 mL of the BN recommendations (20 mL attle, Washington; MedStar Washington Hospital above or below) for that hour at least 75% of the time. Center/ Georgetown University SOM, Washington, Results: For 285 patients, average age, weight, and TBSA DC, District of Columbia; The Arizona Burn Center ± ± ± were 45.6 16.8 years, 87.0 22.8 kg, and 39.0 17.8%, Valleywise Health, Phoenix, Arizona; University of ± with partial/full thickness percentages of 22.2 15.2% and Utah, Salt Lake City, Utah; Johns Hopkins Univer- ± 17.0 19.7%, respectively. Analysis of 286 patients in the sity School of Medicine, Baltimore, Maryland; Soroka ± first 24 hours of resuscitation revealed an average of 4.07 University Medical Center, Beer Sheba, HaDarom 1.76 mL/kg/TBSA and 151.48 ± 77.46 mL/kg of primary crystalloid fluid. When considering all fluids administered to Introduction: Bromelain Based Debridement (BBD) of include colloids and medications, enteral and oral feeds, and deep thermal burns has been approved for use in Europe, oral resuscitation fluids, average volumes in the first 24 hours Argentina, Russia, South Korea, Peru, and Israel, and is an in- were 4.68 ± 2.06 mL/kg/TBSA and 175.01 ± 92.22 mL/ vestigational product in the United States. Topline results of kg. To account for delayed presentation after burn injury, acute stage endpoints of the DETECT Phase 3 multicenter examining 24 hours of resuscitation regardless of the initia- RCT have been reported previously. The aim of this abstract tion of resuscitation, average volumes for primary and total is to present the 12-month follow-up of predefined endpoints fluids were 5.28± 2.54 mL/kg/TBSA, 201.11 ± 106.53 mL/ of scar quality, function and quality of life (QoL). kg, 6.35 ± 2.95 mL/kg/TBSA and 244.08 ± 133.5 mL/kg re- Methods: One-hundred and seventy-five adult patients spectively. There was a significant decrease incidence of shock with deep burns were randomized in a Phase 3 clinical trial in the BN-guided group versus the non-BN-guided group to one of 3 treatment arms – BBD, Standard of Care (SOC), (p< 0.05). or Gel vehicle (placebo control) in a 3:3:1 ratio (75 BBD, Conclusions: The Burn Navigator provides comparable 75 SOC, and 25 Gel). Scar quality (cosmesis) and function resuscitation volumes of primary crystalloid fluid to the data were analyzed for longer-term data collected at 3, 6, 12 Parkland Formula. When all fluids are considered, the BN (and 24 - data not yet final) months. Cosmesis and function device recommends total fluid infusion less than the Ivy Index were measured using Modified Vancouver Scar Scale (MVSS) (250 mL/kg/24 hrs) and was associated with a decreased in- and Patient and Observer Scar Assessment Scale (POSAS) to cidence of shock. Early initiation of the BN device resulted demonstrate that BBD treatment was non-inferior to SOC in lower overall fluid volumes during the first 24 hours of treatment, as measured at 12 months from wound closure resuscitation. date, evaluated by assessors blinded to the treatment arm. QoL was measured by the EQ-5D (EuroQol 5 Dimensions), VAS (Visual Analog Scale) and BSHS-B (Burn Specific Health Scale – Brief) scales. Missing values were imputed in the analysis using multiple imputation, with best case-worst case imputations as sensitivity analyses. April 7 - 9, 2021 • Chicago, IL S1 Results: The 12-month follow-up mean MVSS scores were T3 Are Burns a Chronic Condition: Examining lower (better) for the BBD group (3.70±2.10) than for the SOC (5.08±3.11) and Gel groups (5.63±2.99). A regression Physical and Mental Functioning up to 20 analysis showed that BBD has a 1.36 MVSS point advantage Years After Injury over SOC after adjustment for all other variables in the model Callie Abouzeid, BA, Audrey E. Wolfe, MPH, (p-value = 0.0027). The 95% CI for this treatment effect was Gretchen J. Carrougher, MN, RN, Nicole S. Gibran, -2.24 to -0.48, excluding the pre-defined non-inferiority MD, FACS, Radha K. Holavanahalli, Ph.D., margin of +1.9 points, thus establishing non-inferiority of Pengsheng Ni, Kimberly Roaten, PhD, CRC, BBD treatment compared with SOC. Note that the interval Colleen M. Ryan, MD FACS, Oscar E. Suman, also excludes 0, indicating superiority of BBD over SOC. The PhD, MS, Steven E. Wolf, MD, Lewis E. Kazis, 3- and 6-month follow-up MVSS scores are also lower for Doctor of Science (Health Services Research), the BBD group (5.51±3.09, 4.43±2.59) than for the SOC Jeffrey C. Schneider, MD (6.63±3.44, 5.43±3.75) and Gel (7.56±2.67, 8.89±3.37) Spaulding Rehabilitation Hospital, Cambridge, groups. POSAS total scores followed similar trends to MVSS Massachusetts; Spaulding Rehabilitation Hospital, scores but did not reach statistical significance at 12 months. Boston, Massachusetts; University of Washington, Se- QOL was generally similar among the treatment arms. attle, Washington; University of Washington, Seattle, Conclusions: In addition to the significant acute stage Washington; UT Southwestern Medical Center, Dal- results presented previously, the long-term results of this RCT las, Texas; Boston University School of Public Health, further demonstrate the safety of BBD treatment, including Boston, Massachusetts; UT Southwestern Medical significantly better 12-month follow-up MVSS scores. Center, Dallas, Texas; Massachusetts General Hospi- tal/Harvard/Shriners Hospitals for Children-Boston, Boston, Massachusetts; University of Texas Medical Branch, Galveston, Texas; University of Texas Medical Branch, Galveston, Texas; Boston University School of Public Health, Boston, Massachusetts; Spaulding Rehabilitation Hospital/Harvard Medical School, Boston, Massachusetts Introduction: Burn survivors often face many long-term physical and psychological symptoms associated with their injury. To date, however, few studies have examined the im- pact of burn injuries on quality of life beyond 2 years post- injury. The purpose of this study is to examine the physical and mental well-being of burn survivors up to 20 years after injury. Methods: Data from the Burn Model System National Database (1997–2020) were analyzed. Patient-reported out- come measures were collected at discharge with a recall of preinjury status, and then at 5, 10, 15, and 20 years after injury. Outcomes examined were the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Short Form-12. Trajectories were developed using linear mixed methods model with repeated measures of PCS and MCS scores over time and controlling for demographic and clinical variables. The model fitted score trajectory was generated with 95% confidence intervals to demonstrate score changes over time and associations with covariates. Results: The study population included 420 adult burn survivors with a mean age of 42.4 years. The population was mainly male (66%) and white (76.4%) with a mean burn size of 21.5% and length of hospital stay of 31.3 days. Higher PCS scores were associated with follow-up time points closer to injury, shorter hospital stay, and younger age. Similarly, higher MCS scores were associated with earlier follow-up time points, shorter hospital stay, female gender, and non- perineal burns. MCS trajectories are demonstrated in the Figure. Conclusions: Burn survivors’ physical and mental health worsened over time.