Dermal Micrografts in Regenerative Surgery

Regenerative Medicine Clinical Trial

— Rigenera  

Official title:

Role of Autologous Dermal Micrografts in Regenerative Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912675
• Other study ID #: 2142CE
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: April 2019
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Regenerative Medicine

Intervention

Procedure:
• Integra® dermal substitute and RigeneraTM protocol
Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri IRCCS	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous re-epithelialization.	Percentage of patients with spontaneous re-epithelialization of the total wound surface higher than 25% as assessed by Image J Software	4 weeks