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.

A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns.

OBJECTIVE: This phase 3 study evaluated StrataGraft construct as a donor-site sparing alternative to autograft in patients with deep partial-thickness (DPT) burns. METHODS: Patients aged ≥18 years with 3-49% total body surface area (TBSA) thermal burns were enrolled. In each patient, 2 DPT areas (≤2000cm2 total) of comparable depth after excision were randomized to either cryopreserved StrataGraft or autograft. Coprimary endpoints were: the difference in percent area of StrataGraft treatment site and autograft treatment site autografted at Month 3 (M3), and the proportion of patients achieving durable wound closure of the StrataGraft site without autograft at M3. Safety assessments were performed in all patients. Efficacy and safety follow-up continued to 1 year. RESULTS: Seventy-one patients were enrolled. By M3, there was a 96% reduction in mean percent area of StrataGraft treatment sites that required autografting, compared with autograft treatment sites (4.3% vs 102.1%, respectively; P<.0001). StrataGraft treatment resulted in durable wound closure at M3 without autografting in 92% (95% CI: 85.6, 98.8; n/n 59/64) of patients for whom data were available. The most common StrataGraft-related adverse event was pruritus (15%). CONCLUSIONS: Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting. CLINICAL TRIAL IDENTIFIER: NCT03005106.

Fireworks and Seafood Boils: The Epidemiology of Burns in Louisiana.

Epidemiological trends provide a means for targeting efforts in burn prevention. There have been but few regional-specific studies concerning burns in the southern United States. This study describes burn injury trends experienced by a single burn center in Louisiana. We also investigate the temporal relationships of several activities informally known for having a high risk for burn injury among local providers. Data were retrospectively extracted from the records of all patients treated for burn injuries at the regional burn center from 2012 to 2018 in both inpatient and outpatient settings. Demographical data and burn injury characteristics were noted. A total of 6,498 patients were included (1,593 inpatient, 4,905 outpatient). The most common burn etiologies were scald and flame, with flame being associated with more severe injuries. Overall incidence was disproportionally high in males and children less than 4 years of age. Total incidence was highest in Caucasians, though African Americans held the highest annual incidence rate specific to this population. The most common situation at the time of burn injury involved the consumption or preparation of food or beverages. Significant variation was observed in the rates of different injury situations throughout the year. Notably, burns related to seafood, heating, and firework activity occurred more often during crawfish season, colder months, and the months of January and July, respectively. In addition to establishing preliminary trends, these data may be useful in guiding the development of future evidence-based prevention efforts to target the most detrimental burn injuries in this population.

Variability in Management of Patients With SJS/TEN: A Survey of Burn Unit Directors.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare, type IV hypersensitivity reactions of the skin and mucosa. These reactions (SJS/TEN) are frequently managed in burn units; however, no standardized guidelines exist for the treatment and management of SJS/TEN. To gain insight into current SJS/TEN management practices, a survey on admission, diagnosis, and management, was conducted across accredited burn units in the United States. A 28-item question survey on SJS/TEN management, diagnosis, and treatment practices was distributed among medical directors and co-directors of American Burn Association-verified burn centers. Responses were collected over a 6-week period. In total, 31 (48% response rate) burn unit medical directors/co-directors participated in the survey. The majority of responders indicate that acceptance to their burn unit is based on clinical suspicion of SJS/TEN (74%), and biopsy or dermatological evaluation is not required (67 and 87%, respectively). More than half (61%) of the burn units have their own SJS/TEN protocol in place. No consensus was observed on different treatment aspects, such as infection control, systemic treatment, and wound care. Most directors reported their burn units to consult ophthalmology (77%) and dermatology (54%) for the management of patients with SJS/TEN. Large variability in procedures of admission, treatment, and management of SJS/TEN was identified across burn centers. This study demonstrates the urgent need for SJS/TEN standardized guidelines in the United States.