N/A
N=22
Autologous Regeneration of Tissue (ART) for Wound Healing
Wound of Skin
Bottom Line
View on ClinicalTrials.gov: NCT03796988 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change of Pain on Harvesting of Skin at Donor Site. — 2.6 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Autologous Regeneration of Tissue (ART) device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Pain on Harvesting of Skin at Donor Site. |
2.6 | — |
| PRIMARY Time to Healing of Donor Sites |
24 | — |
| SECONDARY Wound Healing of Recipient Site |
-3.6 | — |
| SECONDARY Histologic Evaluation |
— | — |
Summary
The purpose of this research study is to learn about a new device, Autologous Regeneration of Tissue (ART), for collecting skin grafts from participant's own skin.
Eligibility Criteria
Inclusion Criteria
- Adults from 18 to 90 years of age.
- Patients that have a chronic wound in any area of the body defined as having been present for at least 30 days of duration.
- Able and willing to give consent for the study.
Exclusion Criteria
- Pregnant women (Urine hCG test will be performed at baseline on women of child bearing potential).
- Adults unable to consent.
- Prisoners.
- Subjects requiring concurrent systemic antimicrobials during the study period for any infection.
- Subjects with leg lesions and clinically significant and unreconstructed peripheral arterial disease.
- Subjects who are receiving immunosuppressive agents, radiation therapy, or cytotoxic agents.
- Subjects who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
- Subjects with other conditions considered by the investigator to be reasons for disqualification that may jeopardize subject safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
Data sourced from ClinicalTrials.gov (NCT03796988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.