A Randomized, Prospective, Within-Patient, Controlled Clinical Study to Investigate Full Thickness Skin Tissue Columns as a Novel Skin Replacement Therapy
Abstract
Split-thickness skin grafts (STSG), the current standard of care for wounds too large to heal effectively by linear closure, are typically harvested with a dermatome that TANGENTIALLY removes the epidermis and a thin layer of dermis from a donor site. Even though STSG have been the mainstay of skin replacement therapy since pinch grafts were described in 1869 by Reverdin, there are well-known limitations. In particular, STSG fail to adequately recapitulate some basic features of skin including pliability, uniform texture and color, and adnexal functions of lubrication and temperature regulation. Further, there is a finite number of possible re-harvests and donor sites from tangential harvests are not only painful (from exposure of nerve endings in the dermis) but also result in disfiguring scars in a previously uninjured region. Orthogonal skin harvest is a novel technique to obtain donor skin in the form of tissue columns for skin replacement therapy. The transfer of full thickness skin elements in columnar bits to a recipient wound bed may result in more functional skin and less donor site morbidity than conventional, tangentially-harvested, split thickness skin grafts. In this study, we propose to evaluate and compare tissue columns obtained from an FDA-cleared device, ART(trademark) (Autologous Regeneration of Tissue), to split thickness skin grafts obtained from a conventional skin dermatome in a prospective, randomized, within patient, controlled study to determine quality and speed of healing as well as the need for re-grafting and donor site morbidity. The purpose of the study is to compare the efficacy and feasibility of skin harvest and replacement using: (1) Autologous Regeneration of Tissue (ART) device, which harvests FSTCs orthogonally to (2) conventional STSG harvested tangentially. The primary specific aim is to compare the quality of healing of the FSTC grafted recipient sites with the conventional STSG recipient sites.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2022
- Accession Number
- AD1173830
Entities
People
- Rodney K Chan
- Victoria Diaz