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NCT02234193 · ClinicalTrials.gov registry record · Early Phase 1
Reducing Side-effects of Autologous Skin Tissue Harvesting
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
NCT02234193: Completed Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT02234193 is a Early Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02234193, a Early Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The investigators are doing this research study to learn about how the skin heals after many microscopic skin biopsies are collected. Skin-grafting is a life-saving procedure for people with large area skin wounds caused by burns or trauma. Conventional autologous (self) skin grafting techniques require the creation of large donor site wounds, causing numerous complications including pain, infection, blistering, discoloration, and scarring. Based on previous research, many of these adverse effects can be improved, or even eliminated, by harvesting skin tissue in very small biopsies. These "micro-biopsies" are less than the size of a sewing pin. Then, they are put back together into a skin graft. This concept is based on clinical observations from fractional photothermolysis laser therapy, an FDA approved laser that has been previously developed by the investigators research group for the treatment of scars and ageing skin. With this laser technique, thousands to millions of small burns are produced by laser on a patient's skin, and the skin responds by healing the damaged areas to create new healthy skin within days and without scarring. Although the results of laser treatment are well-known, it is not known what happens when we harvest the skin using needles instead of using the laser to cut the skin. The investigators also would like to understand how the body heals the skin. Understanding how this works helps in understanding wound healing, and may lead to future treatments for healing large wounds, disfiguring burn scars, and preventing scar formation. A tummy tuck (abdominoplasty surgery) is done to remove excessive skin of the belly. This is an elective surgery, in other words, it is optional and usually done for cosmetics reasons (to improve the appearance). The skin of the belly that is removed during an abdominoplasty surgery (tummy tuck) is discarded. The skin of the area removed is called "pre-abdominoplasty skin". The investigators would like to stu
Interventions
- DEVICE Micro biopsy
- PROCEDURE Lidocaine with epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-06-01 |
| Est. Completion | 2019-03-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02234193
The ClinicalTrials.gov registry entry for NCT02234193 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Micro biopsy is the first listed.
NCT02234193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02234193 about?
NCT02234193 is a clinical study titled "Reducing Side-effects of Autologous Skin Tissue Harvesting". The investigators are doing this research study to learn about how the skin heals after many microscopic skin biopsies are collected. Skin-grafting is a life-saving procedure for people with large area skin wounds caused by burns or trauma. Conventional autologous (self) skin grafting techniques re...
What is the current status of trial NCT02234193?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2016-06-01. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT02234193?
The interventions under investigation include: Micro biopsy (DEVICE), Lidocaine with epinephrine (PROCEDURE).
Who is sponsoring clinical trial NCT02234193?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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