Reducing Side-effects of Autologous Skin Tissue Harvesting

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

March 31, 2019

Study Completion Date

March 31, 2019

Conditions
Scar
Interventions
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 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

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

Trial Locations (1)

02114

Wellman Center for Photomedicine, Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT02234193 - Reducing Side-effects of Autologous Skin Tissue Harvesting | Biotech Hunter | Biotech Hunter