Skin substitutes are considered a useful alternative for occlusive dressings in the treatment of superficial burns as they reduce the frequency of dressing replacement. This phase II randomized controlled trial aimed to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive xenograft dressing for the treatment of burn wounds in humans. In order to assess the use of tilapia skin, the following variables were evaluated: number of days for wound healing, the number of times the occlusive dressing was changed, use of anesthetics or analgesics, pain assessment using the Visual Analogue Scale, and evaluation of burn improvement on the day of dressing removal. In total, 62 participants completed the study. It was found that in participants treated with tilapia skin, complete reepithelialization occurred in significantly fewer days; reported pain intensity was lower (study arms B and C), the amount of anesthetics/analgesics required was lower (study arms B and C), and the necessity of dressing changes was significantly reduced in comparison with volunteers treated with silver sulfadiazine. In our study, the tilapia skin xenograft showed good efficacy as an occlusive biological dressing for burn wound treatment in humans.

Tilapia skin has non-infectious microbiota, high amounts of type I collagen, and similar morphological structure to human skin, so it has been suggested as a potential xenograft for the management of burn wounds. A 23-year-old male patient, with no comorbidities, arrived at our burn treatment center after a thermal injury caused by contact with flames from a gunpowder explosion. Superficial partial thickness burns were present in his right upper limb and deep partial thickness burns were present in his left upper limb. Tilapia skin was applied to the lesions, leading to complete reepithelialization within 12 and 17 days of treatment, respectively. No dressing changes were needed and no side effects were observed. Tilapia skin carries the promise of an innovative, easy-to-apply and highly available product that can become the first nationally studied animal skin registered by the National Sanitary Surveillance Agency for use in the treatment of burns.

Burns represent the fifth most common cause of nonfatal childhood injuries in the world. The Nile tilapia skin (Oreochromis niloticus) is widely available in Brazil and demonstrated, in previous studies, noninfectious microbiota, morphological structure similar to that of human skin, and good outcomes when used as a xenograft for treatment of experimental burns in rats. A 3-year-old boy was admitted to a burn treatment center in Fortaleza, Brazil, with scalds in the left side of the face, neck, anterior thorax, abdomen, and left arm. Involvement of 18% of total body surface area with superficial partial thickness burns was calculated. After local Institutional Review Board approval and written permission from the patient’s legal caregiver were obtained, application of tilapia skin as an occlusive dressing was performed. Good adherence of tilapia skin to the wound bed was detected. The patient was discharged from the hospital with a total of 10 days required for the complete re-epithelialization of his superficial partial thickness burn. No adverse effects were noted. We believe that further studies conducted by our researchers will allow this innovative, low-cost, widely available and easy to apply biomaterial to firm itself as a relevant option in the therapeutic arsenal of pediatric burns, producing significant social and financial impact for the health system.

Background: In a phase II study comparing Nile tilapia fish skin to silver sulfadiazine cream for outpatient management of superficial partial-thickness burns, the fish skin decreased reepithelialization time (average reduction, 1.43 days), dressing changes (average reduction, 3.72 dressings), and visual analogue scale pain scores. The present study aimed to further evaluate Nile tilapia fish skin efficacy for superficial partial-thickness burns. Unlike silver sulfadiazine cream, the fish skin has good adherence to the wound bed, which may prevent infections and decrease need for dressing changes. Thus, it could be a low-cost alternative to hasten healing and improve pain of burn patients. Methods: A phase III randomized controlled trial was conducted from April of 2017 to October of 2018 in Fortaleza, Brazil, and included 115 outpatients aged 18 to 70 years with superficial partial-thickness burns affecting 15 percent or less of body surface area and no previous treatment. Fifty-seven patients were treated with the glycerolized fish skin and 58 with silver sulfadiazine cream 1%. Primary outcomes were reepithelialization time, number of dressings, treatment-related costs, and pain intensity, assessed by means of visual analogue scale, Electronic von Frey, Burns Specific Pain Anxiety Scale, and analgesic use. Patients were evaluated every 48 hours. Results: Patients treated with fish skin required fewer days for reepithelialization (9.7 ± 0.6 days versus 10.2 ± 0.9 days; p = 0.001) and fewer dressings (1.6 ± 0.7 versus 4.9 ± 0.5; p < 0.001). They also had decreased analgesic needs and visual analogue scale, Burns Specific Pain Anxiety Scale, and Electronic von Frey measurements. Finally, fish skin use reduced the final average treatment-related cost per patient by 42.1 percent. Conclusion: By hastening reepithelialization, improving burn-related pain, and decreasing treatment-related costs, Nile tilapia fish skin could benefit the resource-poor public health systems of developing countries. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

B-cell-maturation-antigen (BCMA)-directed therapies are highly active for multiple myeloma, but infections are emerging as a major challenge. In this retrospective, single-center analysis we evaluated infectious complications after BCMA-targeted chimeric-antigen-receptor T-cell therapy (CAR-T), bispecific-antibodies (BsAb) and antibody-drug-conjugates (ADC). The primary endpoint was severe (grade ≥3) infection incidence. Amongst 256 patients, 92 received CAR-T, 55 BsAb and 109 ADC. The incidence of severe infections was higher with BsAb (40%) than CAR-T (26%) or ADC (8%), including grade 5 infections (7% vs 0% vs 0%, respectively). Comparing T-cell redirecting therapies, the incidence rate of severe infections was significantly lower with CAR-T compared to BsAb at 1-year (incidence-rate-ratio [IRR] = 0.43, 95%CI 0.25−0.76, P = 0.004). During periods of treatment-emergent hypogammaglobulinemia, BsAb recipients had higher infection rates (IRR:2.27, 1.31−3.98, P = 0.004) and time to severe infection (HR 2.04, 1.05–3.96, P = 0.036) than their CAR-T counterparts. During periods of non-neutropenia, CAR-T recipients had a lower risk (HR 0.44, 95%CI 0.21−0.93, P = 0.032) and incidence rate (IRR:0.32, 95% 0.17–0.59, P < 0.001) of severe infections than BsAb. In conclusion, we observed an overall higher and more persistent risk of severe infections with BsAb. Our results also suggest a higher infection risk during periods of hypogammaglobulinemia with BsAb, and with neutropenia in CAR-T recipients.

Despite being the mainstay of management for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), there is limited data regarding the impact of tocilizumab (TCZ) and corticosteroids (CCS) on chimeric antigen receptor (CAR) T-cell efficacy in multiple myeloma (MM). The present study aims to evaluate the prognostic impact of these immunosuppressants in recipients of BCMA- or GPRC5D-directed CAR T cells for relapsed/refractory MM. Our retrospective cohort involved patients treated with commercial or investigational autologous CAR T-cell products at a single institution from March 2017–March 2023. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall response rate (ORR), complete response rate (CRR), and overall survival (OS). In total, 101 patients (91% treated with anti-BCMA CAR T cells and 9% treated with anti-GPRC5D CAR T cells) were analyzed. Within 30 days post-infusion, 34% received CCS and 49% received TCZ for CRS/ICANS management. At a median follow-up of 27.4 months, no significant difference in PFS was observed between CCS and non-CCS groups (log-rank p = 0.35) or between TCZ and non-TCZ groups (log-rank p = 0.69). ORR, CRR, and OS were also comparable between evaluated groups. In our multivariable model, administering CCS with/without TCZ for CRS/ICANS management did not independently influence PFS (HR, 0.74; 95% CI, 0.36–1.51). These findings suggest that, among patients with relapsed/refractory MM, the timely and appropriate use of CCS or TCZ for mitigating immune-mediated toxicities does not appear to impact the antitumor activity and long-term outcomes of CAR T-cell therapy.