Dermal Micrografts in Regenerative Surgery — Rigenera  

Regenerative Medicine Clinical Trial

Official title: Role of Autologous Dermal Micrografts in Regenerative Surgery

Status Completed

Clinical Trial Summary

Objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model.

Clinical Trial Description

The aim of the study is the objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model. The study includes 20 patients with 24 acute post-surgical soft tissue loss and a planned sequential two-stage repair with dermal substitute and autologous split-thickness skin graft. Each acute post-surgical soft tissue loss is randomized to be treated either with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with Rigenera™ technology (group A - Rigenera™ protocol) or with Integra® dermal substitute only (group B - Control). The re-epithelialization rate in the wounds is assessed in both groups at 4 weeks through digital photography with the software "Image J". The dermal cell suspension enrichment with the Rigenera™ technology is considered effective if the re-epithelialized area is higher than the 25% of the total wound surface as this threshold is considered far beyond the expected spontaneous re-epithelialization rate. ;

Related Conditions & MeSH terms

• Regenerative Medicine

• NCT number: NCT03912675
• Study type: Interventional
• Source: Istituti Clinici Scientifici Maugeri SpA
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Completion date: January 31, 2019