Clinical Trial

Reducing Side-Effects of Autologous Skin Tissue Harvesting

Study Description

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 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Device - Micro biopsy

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 administ ...read more on ClinicalTrials.org

Procedure - Lidocaine with epinephrine

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

Additional Information

Official Study Title

A Pilot Clinical Trial to Reduce Side-effects of Autologous Skin Tissue Harvesting

Clinical Trial ID

NCT02234193

ParticipAid ID

Le39nb