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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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower). 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
Primary Outcome
The extent of scarring caused by the harvesting of micro-skin columns will be assessed by investigators and patients using the Patient and Observer Scar Assessment Scale (POSAS) at all of the follow-up time points. Patient and Observer Scar Assessment Scale (POSAS)
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 |
What the finished NCT02234193 record still lists
NCT02234193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Micro biopsy is the first listed.
NCT02234193 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02234193's enrollment target sits among peer trials
8 1783rd of 2000 higher than 176 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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