Thai Novel Cost-Effectiveness Biocellulose Dressing: Clinical Trial Phase I, Randomized Controlled Trial
Navarat Gosoom¹, Nantaporn Namviriyachote², Suttipong Tianwattanatada², Kusuma Chinaroonchai², Suchada Kittidacha², Tanut Sornmanapong², Kris Keorochana², Pornprom Muangman²
Affiliation : ¹ Department of Surgery, Golden Jubilee Medical Center, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand; ² Division of Trauma Surgery, Department of Surgery, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
Background: Biocellulose wound dressings offer flexibility, high tensile strength, and water-retention properties, resulting in a cool and painless dressing experience. However, their usage has been limited due to high costs. In 2020, the PTT Research and Development Department introduced “Innaqua®,” a novel biocellulose wound dressing that excels in fluid absorption capacity, desorption, wound dressing surface, and wound moisturization. This product is particularly suitable for developing countries, as it combines low cost with high effectiveness, thereby enhancing treatment accessibility. However, it lacks clinical studies.
Objective: To evaluate the clinical safety of Innaqua® for human use.
Materials and Methods: A randomized controlled trial, clinical safety study was conducted with 63 healthy volunteers. Skin irritation and allergic reactions were analyzed.
Results: Clinical safety studies of Innaqua® indicated non-inferiority in terms of erythema at 4.8% versus 4.8% (p=0.012) and allergic reactions at 3.2% versus 4.8% (p=0.004) compared with Bactigras®. No edema occurred with either wound dressing.
Conclusion: Innaqua® is a biocellulose wound dressing researched and developed in Thailand. It creates an optimal environment for wounds. The present study demonstrated clinical safety in human use. Innaqua® emerges as a new, cost-effective option for biocellulose wound dressing, catering to a broader population.
Received 22 August 2024 | Revised 26 September 2024 | Accepted 9 October 2024
DOI: 10.35755/jmedassocthai.2024.12.1008-1012-01488
Keywords : Biocellulose; Innaqua; Thai; Allergy; Safety
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