A Pilot Clinical Trial to Reduce Side-effects of Autologous Skin Tissue Harvesting
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Scar
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Evaluation of Efficacy - Change from baseline scarring at 8 weeks
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Richard Rox Anderson, MD
Professor of Dermatology, Director of the Wellman Center for Photomedicine
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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)