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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy
Spontaneous re-epithelialization.
Percentage of patients with spontaneous re-epithelialization of the total wound surface higher than 25% as assessed by Image J Software
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.