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Dermal Micrografts in Regenerative Surgery (Rigenera)

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ClinicalTrials.gov Identifier: NCT03912675
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Regenerative Medicine Procedure: Integra® dermal substitute and RigeneraTM protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study includes 20 patients with 24 post-surgical defect in any site of the body with a size range 4-400 cm2. The acute post-surgical soft tissue loss is considered the experimental unit of the study irrespective of the number of wounds per patient. Each unit is randomized to be treated either with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol (group A - RigeneraTM protocol - 12 units) or with Integra® dermal substitute only (group B - Control - 12 units). The expected endpoint is a spontaneous re-epithelialization higher than 25% of the total wound area in group A at 4 weeks. The secondary endpoint is the comparison of the re-epithelialization rate at 4 weeks after the first surgical stage between the group A and the controls. The re-epithelialization rate in the wounds is assessed through digital photography with the software "Image J".
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Role of Autologous Dermal Micrografts in Regenerative Surgery
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: RigeneraTM protocol
Teatment with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol.
Procedure: Integra® dermal substitute and RigeneraTM protocol
Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol

Experimental: Control
Treatment with Integra® dermal substitute only.
Procedure: Integra® dermal substitute and RigeneraTM protocol
Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol




Primary Outcome Measures :
  1. Spontaneous re-epithelialization. [ Time Frame: 4 weeks ]
    Percentage of patients with spontaneous re-epithelialization of the total wound surface higher than 25% as assessed by Image J Software



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912675


Locations
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Italy
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy, 27100
Sponsors and Collaborators
Istituti Clinici Scientifici Maugeri SpA
Investigators
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Principal Investigator: Angela Faga, Professor Università degli Studi di Pavia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituti Clinici Scientifici Maugeri SpA
ClinicalTrials.gov Identifier: NCT03912675     History of Changes
Other Study ID Numbers: 2142CE
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituti Clinici Scientifici Maugeri SpA:
Cell transplants
Autografting