Clinical trial NCT03912675: Dermal Micrografts in Regenerative Surgery
Official title: Role of Autologous Dermal Micrografts in Regenerative Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regenerative Medicine
Keywords: Cell transplants
Autografting
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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".
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Spontaneous re-epithelialization.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
Study officials:
affiliation: Università degli Studi di Pavia
name: Angela Faga, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.