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

BACKGROUND Glycerolized Nile tilapia skin showed promising results when used for burn treatment in phase II and phase III randomized controlled trials. This pilot study aims to evaluate the effectiveness of lyophilized Nile tilapia skin as a temporary skin substitute for superficial partial-thickness burns by comparing it to silver-impregnated sodium carboxymethylcellulose dressing. METHODS This was a randomized, prospective, open-label, 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 total body surface area. 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. RESULTS 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 side effects were detected. CONCLUSION Lyophilized Nile tilapia skin shares the same characteristics of an ''ideal'' wound dressing demonstrated by glycerolized Nile tilapia skin in previous studies. Also, it demonstrated non-inferiority for burn management when compared to silver-impregnated sodium carboxymethylcellulose dressing. The safety and efficacy of lyophilized Nile tilapia skin demonstrated in this pilot study may allow the development of larger phase II and phase III RCTs in a near future.