Dermal Micrografts in Regenerative Surgery

NCT03912675 | Completed

• 1 other identifier: 2142CE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Regenerative Medicine

Keywords

Cell transplants; Autografting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

RigeneraTM protocol

EXPERIMENTAL

Teatment with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol.

Procedure: Integra® dermal substitute and RigeneraTM protocol

Control

EXPERIMENTAL

Treatment with Integra® dermal substitute only.

Procedure: Integra® dermal substitute and RigeneraTM protocol

Interventions

Integra® dermal substitute and RigeneraTM protocol PROCEDURE

Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol

Control; RigeneraTM protocol

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

Location

Related Publications (1)

• Tresoldi MM, Graziano A, Malovini A, Faga A, Nicoletti G. The Role of Autologous Dermal Micrografts in Regenerative Surgery: A Clinical Experimental Study. Stem Cells Int. 2019 Sep 8;2019:9843407. doi: 10.1155/2019/9843407. eCollection 2019.

  PMID: 31582991 DERIVED

Study Officials

• Angela Faga, Professor

  Università degli Studi di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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".

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 11, 2019
• Study Start: July 11, 2017
• Primary Completion: September 30, 2018
• Study Completion: January 31, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

IT (1)