Trials / Completed
CompletedNCT03912675
Dermal Micrografts in Regenerative Surgery
Role of Autologous Dermal Micrografts in Regenerative Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA · Academic / Other
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Integra® dermal substitute and RigeneraTM protocol | Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol |
Timeline
- Start date
- 2017-07-11
- Primary completion
- 2018-09-30
- Completion
- 2019-01-31
- First posted
- 2019-04-11
- Last updated
- 2019-04-11
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03912675. Inclusion in this directory is not an endorsement.