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Micro-biopsies may revolutionize skin grafting

NCT ID NCT02234193

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested how skin heals after taking very small biopsies, called micro-biopsies, which are smaller than a sewing pin. Eight healthy adults scheduled for tummy tuck surgery had these micro-biopsies taken from skin that would later be removed. The goal was to see if this method causes less scarring and side effects than standard skin grafting. The study aims to understand wound healing and could lead to better treatments for large wounds and burns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
micro-biopsy device
What this could lead to
If successful, this could lead to less painful and less scarring methods for harvesting skin grafts.
What could go wrong
This is a very early pilot study with only 8 participants, so results may not apply broadly. The approach is still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

8 people

The number who actually took part.

Started

Jun 2016

Finished

Mar 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy adults (\>18 years old) scheduled to undergo elective abdominoplasty surgery at MGH, male or female. 2. Willingness to participate in the study 3. Willingness to undergo biopsies of full-thickness skin tissue from the pre-abdominoplasty skin, and have the biopsy sites marked by tattoos. 4. Informed consent agreement signed by the subject 5. Willingness to follow the treatment and follow-up schedules, and post treatment care requirements 6. Willingness to not use topical or systemic (oral) anti-scarring or anti-inflammatory\* medications during the study period. Exclusion Criteria: 1. Subjects who are immunocompromised or immunosuppressed\* 2. Subject is unable to comply with treatment, home care or follow-up visits 3. Subject has an infection or other dermatologic condition in the area to be treated 4. Subjects with a personal or family history of keloid formation. 5. Subjects with pre-existing scars, tattoos, birthmarks, or other physical features in the area to be treated, such that the experimental outcome may be confounded. 6. Subjects with a history of coagulopathy, or are taking anticoagulants 7. Subjects taking daily oral aspirin. 8. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 9. Subjects with any contraindications for elective abdominoplasty, as determined by their treating plastic surgeon and/or pre-op anesthesiologist. 10. Subjects with current drug or alcohol addiction. 11. Subjects who are pregnant and/or breastfeeding 12. Subjects with tape adhesive allergies 13. Subjects with known allergies to injectable lidocaine or other topical anesthetics 14. Subjects with uncontrolled or unstable chronic disease such as diabetes, hepatitis, hypertension, etc. 15. Subjects taking oral corticosteroids or topical steroids on the study area. 16. Subjects using prescription or over-the-counter medication or cosmetics containing: retinoids, glycolic acid, salicylic acid or any other remedies that might affect the healing process. (Non-medicated moisturizers are ok). 17. Subjects enrolled in other clinical studies taking any unknown or not-FDA approved medications. 18. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject. Notes: \*About Anti-Inflammatory Medication and Immune Status The inflammatory response associated with tissue wounding is known to have substantial effects on the process of scarring, therefore all subjects who are immunocompromised, or undergoing anti-inflammatory/immunosuppressive therapies will be excluded from the study. All new medication should be reported to study doctor before each visit.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Wellman Center for Photomedicine, Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.