Registry Study Evaluating Safety and Outcomes of Myriad Matrix and Morcells Devices in Soft Tissue Reconstruction Surgery

What this Trial Is About

Researchers are conducting an observational, multi-center, single-arm Phase IV study to evaluate the safety and clinical outcomes of Myriad Matrix and Myriad Morcells devices in soft tissue reconstruction surgeries. This study focuses on participants undergoing various surgical procedures such as abdominal dehiscence, necrotizing soft tissue infection, complex lower extremity wounds, pilonidal sinus, anal fistula, hidradenitis suppurativa reconstruction, and pressure injury reconstruction, among others. The study aims to gather data on healing outcomes and any adverse events related to using these devices as part of standard care. Participants will undergo surgical procedures where Myriad Matrix andor Myriad Morcells devices are used according to the attending physicians clinical judgment and product instructions. The devices may be implanted or used for dermal regeneration, either alone or in combination. Pre-operative preparation and post-operative care are managed by the attending physician based on institutional protocols. The study collects data throughout treatment and follow-up to assess early and late-stage healing and clinical outcomes. Throughout the study, de-identified patient data including quantitative and qualitative assessments and digital images will be collected as part of the registry dataset. Researchers will monitor the proportion of participants experiencing treatment-emergent adverse events over three years. Secondary outcomes include time to complete healing, surgical complications, granulation progress, and skin graft success. Participants care and follow-up occur as part of their standard medical treatment with ongoing safety monitoring during the study period.

Myriad™ Augmented Soft Tissue Reconstruction Registry