A Randomized Comparison Study of Lyophilized Nile Tilapia Skin and Silver-Impregnated Sodium Carboxymethylcellulose for the Treatment of Superficial Partial-Thickness Burns
Edmar Maciel Lima Júnior, Manoel Odorico de Moraes, Bruno Almeida Costa, Francisco Vagnaldo Fechine, Marina Becker Sales Rocha, Mariana Lima Vale, Ana Kely de Loyola Diógenes, Alex Marques Do Nascimento Uchôa, Francisco Raimundo Silva Júnior, Camila Barroso Martins, Tereza de Jesus Pinheiro Gomes Bandeira, Felipe Augusto Rocha Rodrigues, Carlos Roberto Koscky Paier, Maria Elisabete Amaral de Moraes
Abstract
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.