ScarEarly Phase 1NCT02234193
Reducing Side-effects of Autologous Skin Tissue Harvesting
A Early Phase 1 study testing Micro biopsy and Lidocaine with epinephrine in people with Scar, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar
- What is being tested?
- Micro biopsy and Lidocaine with epinephrine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 1 Mar 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (>18 years old) scheduled to undergo elective abdominoplasty surgery at MGH, male or female.
- Willingness to participate in the study
- Willingness to undergo biopsies of full-thickness skin tissue from the pre-abdominoplasty skin, and have the biopsy sites marked by tattoos.
- Informed consent agreement signed by the subject
- Willingness to follow the treatment and follow-up schedules, and post treatment care requirements
- Willingness to not use topical or systemic (oral) anti-scarring or anti-inflammatory* medications during the study period.
Who cannot join
- Subjects who are immunocompromised or immunosuppressed*
- Subject is unable to comply with treatment, home care or follow-up visits
- Subject has an infection or other dermatologic condition in the area to be treated
- Subjects with a personal or family history of keloid formation.
- 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.
- Subjects with a history of coagulopathy, or are taking anticoagulants
Show all 20Show fewer
- Subjects taking daily oral aspirin.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Subjects with any contraindications for elective abdominoplasty, as determined by their treating plastic surgeon and/or pre-op anesthesiologist.
- Subjects with current drug or alcohol addiction.
- Subjects who are pregnant and/or breastfeeding
- Subjects with tape adhesive allergies
- Subjects with known allergies to injectable lidocaine or other topical anesthetics
- Subjects with uncontrolled or unstable chronic disease such as diabetes, hepatitis, hypertension, etc.
- Subjects taking oral corticosteroids or topical steroids on the study area.
- 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).
- Subjects enrolled in other clinical studies taking any unknown or not-FDA approved medications.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Pilot Clinical Trial to Reduce 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 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.
Read more
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 study the effects of the micro-biopsies on pre-abdominoplasty skin to exam how the skin heals over time and to study the skin that will be removed during the abdominoplasty surgery.
This is a pilot study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.
The investigators are asking subjects to take part in this study who are healthy with an abdominoplasty surgery (tummy tuck) scheduled at Massachusetts General Hospital (MGH) by a plastic surgeon .
The investigators will enroll about 28 subjects in this research study, all at MGH.
The Department of Defense is paying for this study to be done.
Read the detailed description
It will take you about 8 weeks to complete this research study. During this time, the investigators will ask you to make up to 7 study visits to MGH.
- Conditions
- Scar
- Being tested
- Micro biopsy, Lidocaine with epinephrine
- Keywords
- wound healing
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro biopsyDevice
This is a prospective, self-controlled study of the healing response after collecting micro skin biopsies of different sizes (from 200 µm to 2 mm in diameter) from up to seven 1.5 x 1.5 cm biopsy sites in pre-abdominoplasty skin areas that are scheduled for surgical removal. The collection procedure will be performed using similar techniques as standard skin biopsies: the skin area involved will be cleaned with alcohol pads, and 1% buffered lidocaine with epinephrine anesthesia will be administered locally, then micro biopsies of skin will be removed by biopsy punch/harvesting needle. No more than 10% of the skin area within each biopsy site will be collected. Tattoo ink as described will be applied to 4 micro-biopsies at the corners of each biopsy test site
Lidocaine with epinephrineProcedure or surgery
Also called Lidocaine
The skin area involved will be cleaned with alcohol pads, and 1% buffered lidocaine with epinephrine anesthesia will be administered locally, prior to the surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Micro biopsies 2mm x control | Active comparator | 2 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
| Micro biopsies 1mm x control | Active comparator | 1 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
| Micro biopsies 0.8 mm x control | Active comparator | 0.8 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
| Micro biopsies 0.6 mm x control | Active comparator | 0.6 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
| Micro biopsies 0.5 mm x control | Active comparator | 0.5 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
| Micro biopsies 0.40 mm x control | Active comparator | 0.4 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
| Micro biopsies 0.20 mm x control | Active comparator | 0.2 mm diameter micro biopsies will be performed on all subjects. Receives: Device: Micro biopsy; Procedure: Lidocaine with epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Efficacy - Change from baseline scarring at 8 weeks
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)
Measured: 24 h, 1 week, 2 weeks, 4 weeks and 8 weeks post treatment
Secondary outcomes (2)
Assessing Subject Side-effects - Change from baseline side-effects at 8 weeks
A Major side effect is defined as an intolerable side effect that would warrant the cessation of treatment because of a risk to the subject's health or because the subject could not tolerate the treatment due to a subjective personal measure (e.g. severe pain). A Minor side effect is a side effect that while uncomfortable would not threaten the subject's health or cause the cessation of treatment due to lack of comfort.
Major side effects include: severe pain (Pain ≥ 8/10 on VAS scale), severe blistering (with potential for secondary infection) and ulceration with scarring. Subjects will be asked for each site to fill in the following sentence: "The side effects I experienced with micro biopsies were: "0: Did not have this side effect / 1: Mild / 2: Moderate / 3: Severe Swelling, Redness, Scabs, Pus or pus blisters, Scaling, Itchy skin, Erosion, Tanning, Lightening of the skin, Minor blistering, Wheals, Bleeding, Folliculitis, Oozing, Numbness
Measured: day 0, 24 h, 1 week, 2 weeks, 4 weeks and 8 weeks after the procedure
Pain assessment - Visual Analog Scale (VAS) - Change from baseline pain at 8 weeks
The VAS will be completed by study subject at baseline and at each follow-up visit for each test site.
Pain is any of the following: sensation of tingling, stinging, prickling, or burning feeling, heat under the skin, tenderness, mild, moderate or severe pain).
Specific VAS form is attached
Subjects will be asked to circle the number below that most closely corresponds to pain associated with each treatment site.
0 1 2 3 4 5 6 7 8 9 10 (NO PAIN WORST PAIN)
Measured: DAY 0, 24h, 1, 2, 4 & 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start1 Jun 2016
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234193
- Sponsor's protocol ID
- 2014P000120
- Status last verified
- Feb 2026
- First submitted
- 27 Aug 2014
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Rasmussen CA, Tam J, Steiglitz BM, Bauer RL, Peters NR, Wang Y, Anderson RR, Allen-Hoffmann BL. Chimeric autologous/allogeneic constructs for skin regeneration. Mil Med. 2014 Aug;179(8 Suppl):71-8. doi: 10.7205/MILMED-D-13-00480.
PubMed 25102552Champlain AH, DiGiorgio CM, Zurakowski D, Sakamoto FH, Anderson RR. Wound Healing After Fractional Skin Harvesting. Dermatol Surg. 2022 Oct 1;48(10):1083-1088. doi: 10.1097/DSS.0000000000003552. Epub 2022 Aug 23.
PubMed 36036977
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial to Reduce Side-effects of Autologous Skin Tissue Harvesting
- ClinicalTrials.gov ID
- NCT02234193
- Acronym / sponsor ID
- 2014P000120
- Conditions
- Scar
- Keywords
- wound healing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study the effects of the micro-biopsies on pre-abdominoplasty skin to exam how the skin heals over time and to study the skin that will be removed during the abdominoplasty surgery.
This is a pilot study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.
The investigators are asking subjects to take part in this study who are healthy with an abdominoplasty surgery (tummy tuck) scheduled at Massachusetts General Hospital (MGH) by a plastic surgeon .
The investigators will enroll about 28 subjects in this research study, all at MGH.
The Department of Defense is paying for this study to be done.
Detailed description
It will take you about 8 weeks to complete this research study. During this time, the investigators will ask you to make up to 7 study visits to MGH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Micro biopsies 2mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine2 mm diameter micro biopsies will be performed on all subjects. |
| Micro biopsies 1mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine1 mm diameter micro biopsies will be performed on all subjects. |
| Micro biopsies 0.8 mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine0.8 mm diameter micro biopsies will be performed on all subjects. |
| Micro biopsies 0.6 mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine0.6 mm diameter micro biopsies will be performed on all subjects. |
| Micro biopsies 0.5 mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine0.5 mm diameter micro biopsies will be performed on all subjects. |
| Micro biopsies 0.40 mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine0.4 mm diameter micro biopsies will be performed on all subjects. |
| Micro biopsies 0.20 mm x control | Active comparator | Device: Micro biopsy, Procedure: Lidocaine with epinephrine0.2 mm diameter micro biopsies will be performed on all subjects. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults (>18 years old) scheduled to undergo elective abdominoplasty surgery at MGH, male or female.
- Willingness to participate in the study
- Willingness to undergo biopsies of full-thickness skin tissue from the pre-abdominoplasty skin, and have the biopsy sites marked by tattoos.
- Informed consent agreement signed by the subject
- Willingness to follow the treatment and follow-up schedules, and post treatment care requirements
Key exclusion criteria (20 listed)
- Subjects who are immunocompromised or immunosuppressed*
- Subject is unable to comply with treatment, home care or follow-up visits
- Subject has an infection or other dermatologic condition in the area to be treated
- Subjects with a personal or family history of keloid formation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro biopsyThis is a prospective, self-controlled study of the healing response after collecting micro skin biopsies of different sizes (from 200 µm to 2 mm in diameter) from up to seven 1.5 x 1.5 cm biopsy sites in pre-abdominoplasty skin areas that are scheduled for surgical removal. The collection procedure will be performed using similar techniques as standard skin biopsies: the skin area involved will be cleaned with alcohol pads, and 1% buffered lidocaine with epinephrine anesthesia will be administered locally, then micro biopsies of skin will be removed by biopsy punch/harvesting needle. No more than 10% of the skin area within each biopsy site will be collected. Tattoo ink as described will be applied to 4 micro-biopsies at the corners of each biopsy test site | Device | Micro biopsies 0.20 mm x control, Micro biopsies 0.40 mm x control, Micro biopsies 0.5 mm x control, Micro biopsies 0.6 mm x control, Micro biopsies 0.8 mm x control, Micro biopsies 1mm x control, Micro biopsies 2mm x control |
| Lidocaine with epinephrineAlso: LidocaineThe skin area involved will be cleaned with alcohol pads, and 1% buffered lidocaine with epinephrine anesthesia will be administered locally, prior to the surgical procedure | Procedure or surgery | Micro biopsies 0.20 mm x control, Micro biopsies 0.40 mm x control, Micro biopsies 0.5 mm x control, Micro biopsies 0.6 mm x control, Micro biopsies 0.8 mm x control, Micro biopsies 1mm x control, Micro biopsies 2mm x control |
Primary outcome
Evaluation of Efficacy - Change from baseline scarring at 8 weeks
Time frame: 24 h, 1 week, 2 weeks, 4 weeks and 8 weeks post treatment
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)
2 secondary outcomes
Assessing Subject Side-effects - Change from baseline side-effects at 8 weeks
Time frame: day 0, 24 h, 1 week, 2 weeks, 4 weeks and 8 weeks after the procedure
Pain assessment - Visual Analog Scale (VAS) - Change from baseline pain at 8 weeks
Time frame: DAY 0, 24h, 1, 2, 4 & 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Results publication: PubMed 25102552Rasmussen CA, Tam J, Steiglitz BM, Bauer RL, Peters NR, Wang Y, Anderson RR, Allen-Hoffmann BL. Chimeric autologous/allogeneic constructs for skin regeneration. Mil Med. 2014 Aug;179(8 Suppl):71-8. doi: 10.7205/MILMED-D-13-00480.
- Derived from this study: PubMed 36036977Champlain AH, DiGiorgio CM, Zurakowski D, Sakamoto FH, Anderson RR. Wound Healing After Fractional Skin Harvesting. Dermatol Surg. 2022 Oct 1;48(10):1083-1088. doi: 10.1097/DSS.0000000000003552. Epub 2022 Aug 23.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Micro biopsy and Lidocaine with epinephrine in people with Scar, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Efficacy - Change from baseline scarring at 8 weeks (time frame: 24 h, 1 week, 2 weeks, 4 weeks and 8 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234193, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.