Reducing Side-effects of Autologous Skin Tissue Harvesting
A Pilot Clinical Trial to Reduce Side-effects of Autologous Skin Tissue Harvesting
1 other identifier
interventional
8
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jun 2016
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2014
CompletedFirst Posted
Study publicly available on registry
September 9, 2014
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 2, 2026
February 1, 2026
2.7 years
August 27, 2014
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
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
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
DAY 0, 24h, 1, 2, 4 & 8 weeks
Other Outcomes (2)
Histopathology examination
8 weeks
Subject Satisfaction Survey - Change from baseline side-effects at 8 weeks
Day 0, 24h, 1, 2, 4 & 8 Weeks
Study Arms (7)
Micro biopsies 2mm x control
ACTIVE COMPARATOR2 mm diameter micro biopsies will be performed on all subjects.
Micro biopsies 1mm x control
ACTIVE COMPARATOR1 mm diameter micro biopsies will be performed on all subjects.
Micro biopsies 0.8 mm x control
ACTIVE COMPARATOR0.8 mm diameter micro biopsies will be performed on all subjects.
Micro biopsies 0.6 mm x control
ACTIVE COMPARATOR0.6 mm diameter micro biopsies will be performed on all subjects.
Micro biopsies 0.5 mm x control
ACTIVE COMPARATOR0.5 mm diameter micro biopsies will be performed on all subjects.
Micro biopsies 0.40 mm x control
ACTIVE COMPARATOR0.4 mm diameter micro biopsies will be performed on all subjects.
Micro biopsies 0.20 mm x control
ACTIVE COMPARATOR0.2 mm diameter micro biopsies will be performed on all subjects.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wellman Center for Photomedicine, Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 25102552RESULTChamplain 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.
PMID: 36036977DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Dermatology, Director of the Wellman Center for Photomedicine
Study Record Dates
First Submitted
August 27, 2014
First Posted
September 9, 2014
Study Start
June 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share