Dermal Micrografts in Regenerative Surgery

Not Applicable

Completed

• Conditions: Regenerative Medicine
• Interventions: Procedure: Integra® dermal substitute and RigeneraTM protocol

• Registration Number: NCT03912675
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-07-11
• Primary Completion: 2018-09-30
• Study Completion: 2019-01-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-10
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Integra® dermal substitute and RigeneraTM protocol	Treatment with Integra® dermal substitute only.
RigeneraTM protocol	Integra® dermal substitute and RigeneraTM protocol	Teatment with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol.

Primary Outcome Measures

Name	Time	Method
Spontaneous re-epithelialization.	4 weeks	Percentage of patients with spontaneous re-epithelialization of the total wound surface higher than 25% as assessed by Image J Software

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri IRCCS; 🇮🇹 Pavia, Italy