Nile Tilapia Fish Skin-Based Wound Dressing Improves Pain and Treatment-Related Costs of Superficial Partial-Thickness Burns: A Phase III Randomized Controlled Trial.

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.

A Randomized Comparison Study of Lyophilized Nile Tilapia Skin and Silver-Impregnated Sodium Carboxymethylcellulose for the Treatment of Superficial Partial-Thickness Burns.

Glycerolized Nile tilapia skin (NTS) showed promising results when used for burn treatment in phases II and III randomized controlled trials. This pilot study aims to evaluate the effectiveness of lyophilized NTS (LNTS) as a temporary skin substitute for superficial partial-thickness burns by comparing it with silver-impregnated sodium carboxymethylcellulose dressing. This was a randomized, prospective, open-label, and controlled pilot study conducted in Fortaleza, Brazil, from April 2019 to December 2019. The 24 participants had ≥18 and ≤70 years of age and superficial partial-thickness burns affecting up to 10% of TBSA. Primary outcomes were the number of dressings performed and pain intensity, assessed via the Visual Analogue Scale and the Electronic von Frey. Secondary outcomes were the level of pain-related anxiety, assessed via the Burns Specific Pain Anxiety Scale, and analgesic consumption. In the test group, the number of dressings and the patient-reported pain after dressing-related procedures were lower. Analgesic intake, pain-related anxiety, and both patient-reported and objectively measured pain before dressing-related procedures were similar for the treatment groups. No adverse effects were detected. LNTS shares the same characteristics of an "'ideal'" wound dressing demonstrated by glycerolized NTS in previous studies. Also, it demonstrated noninferiority for burn management when compared with silver-impregnated sodium carboxymethylcellulose dressing. The safety and efficacy of LNTS demonstrated in this pilot study may allow the development of larger phases II and III RCTs in a near future.

Tratamento de queimaduras de segundo grau profundo em abdômen, coxas e genitália: uso da pele de tilápia como um xenoenxerto / Treatment of deep second-degree burns on the abdomen, thighs, and genitalia: use of tilapia skin as a xenograft

A pele de tilápia possui microbiota não infecciosa e estrutura morfológica semelhante à pele humana. Estudos clínicos fase II, ainda não publicados, mostraram resultados promissores na sua utilização para tratamento de queimaduras. Nos protocolos destes estudos, pacientes com lesões em áreas de dobras de pele, como genitais e região inguinal, foram excluídos, pois achava-se que o biomaterial não aderiria apropriadamente, resultando em um grau de cicatrização inferior. Relato de caso de paciente do sexo feminino, 18 anos, sem comorbidades, com queimaduras de segundo grau profundo em abdômen, região inguinal, parte da genitália e metade superior de ambas as coxas, envolvendo 13,5% da área total da superfície corporal. A pele de tilápia foi aplicada nas lesões levando a uma reepitelização completa com 16 dias de tratamento. Não foram observados efeitos colaterais. A pele de tilápia traz, portanto, a promessa de um produto inovador, de fácil aplicação e alta disponibilidade, que pode se tornar a primeira pele animal nacionalmente estudada e registrada pela Agência Nacional de Vigilância Sanitária, para uso no tratamento de queimaduras. Este relato de caso contribui para reduzir as limitações em relação às áreas anatômicas apropriadas para a aplicação da pele de tilápia, uma vez que, mesmo com a necessidade de reposição de pele, foram obtidos bons resultados com aplicação na genitália e região inguinal.

Tilapia skin has a non-infectious microbiota and a morphological structure similar to human skin. Phase II clinical studies, not yet published, have shown promising results in their use for the treatment of burns. In the protocols of these studies, patients with lesions in areas of skin folds, such as genitals and inguinal regions, were excluded, as it was thought that the biomaterial would not adhere properly, resulting in a lower degree of healing. Case report of a female patient, 18 years old, without comorbidities, with deep second-degree burns in the abdomen, inguinal region, part of the genitalia and upper half of both thighs, involving 13.5% of the total body surface area. Tilapia skin was applied to the lesions leading to a complete re-epithelialization with 16 days of treatment. No side effects were observed. Tilapia skin, therefore, brings the promise of an innovative product, easy to apply, and highly available, which can become the first animal skin nationally studied and registered by the Agência Nacional de Vigilância Sanitária, for use in the treatment of burns. This case report contributes to reduce the limitations concerning the anatomical areas appropriate for the application of tilapia skin, since, even with the need for skin replacement, good results were obtained with application to the genitalia and inguinal region.