Dermal Micrografts in Regenerative Surgery (Rigenera)

Istituti Clinici Scientifici Maugeri SpA

Status

Completed

Conditions

Regenerative Medicine

Treatments

Procedure: Integra® dermal substitute and RigeneraTM protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03912675

2142CE

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Post-surgical defect in any site of the body with a size range 4-400 cm2.

Exclusion criteria

Wound infection, chemotherapy in the last 6 months, use of corticosteroids or immunosuppressive treatment, metabolic, endocrine, autoimmune and collagen diseases.