Clinical utility of silk-elastin sponge in patients with chronic and acute skin ulcers: study protocol of a multi-center clinical trial

Abstract

INTRODUCTION: Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. METHODS: This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. PLANNED OUTCOMES: The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. TRIAL REGISTRATION NUMBER: jRCT2052210072.