Study Comparing Standard Wound Care Alone Versus Standard Care Plus Miro3D Scaffold for Treating Soft Tissue Wounds and Chronic Pressure Ulcers

What this Trial Is About

Researchers are evaluating the outcomes of patients with complex wounds managed with standard treatments alone versus standard treatments combined with Miro3D, a tissue scaffold designed to support wound healing. This prospective randomized controlled trial focuses on two types of wounds acute soft tissue wounds from conditions like fasciotomy or serious infections, and chronic pressure ulcers that have not improved after standard care. The study seeks to provide real-world data on healing quality, cost-effectiveness, and resource use over a 12-week period. Participants will be randomly assigned to receive either standard of care SOC wound treatment alone or SOC plus the Miro3D tissue scaffold. The trial includes two groups one for acute soft tissue wounds and another for chronic pressure ulcers. Outcomes will be assessed over 12 weeks, with some participants crossing over to different treatments to evaluate delayed wound preparation and scaffold application. Treatments will be delivered according to wound type and healing stage, with care including surgical debridement and offloading or compression as appropriate. During the study, participants will undergo regular assessments including digital wound photography and analysis of wound redness to monitor healing. Researchers will also track time to hospital discharge, use of antibiotics and negative pressure wound therapy, pain levels, tissue sampling, and patient-reported ability to care for themselves. The primary outcome is the percentage area reduction of wounds at 4 weeks. Safety and healing progress will be monitored throughout the 12-week treatment period and beyond until study completion in 2028.

Miro3D Randomized Controlled Trial (RCT)