PI J. Peter Rubin, MD
Co-PI Dr. Mark Fleming; Ian Valerio, MD; Benjamin Potter, MD; Jorg Gerlach, MD, PhD; Michael Boninger, MD
Title Autologous Skin Cell Spray for Massive Soft Tissue War Injuries: A Prospective, Case-Control, Multi-Center Trial
Summary: Massive skin and soft tissue injuries of the extremities are common among battle-injured soldiers, often resulting in significant skin deficits. These wounds are routinely treated with a layer of skin taken from an intact donor area of the injured patient’s body and grafted over the wounded area to obtain a healed wound. These skin grafts are often “meshed” or flattened and spread out to increase the size of the skin graft to better cover a large wound. Standard “meshing” increases the size of the donor graft by 1.5 times (1:1.5). Problems with healing and skin irritation remain with such skin grafts when the injured areas are large or deep. Additionally, large graft donor sites may be required to cover the injury. New ways to deal with skin and soft tissue injuries in the war wounded are needed. Scientific research has recently focused on ways to better cover the wounds while still using the patient’s own skin. Donor site skin cells are now being “sprayed” onto the open wounds in an effort to cover larger areas while using smaller donor sites.
We are conducting a three-arm clinical trial. Patients will be randomized to one of three ARMS: ARM 1 will receive standard meshed skin graft, 1:1.5; ARM 2 will receive a wide meshed skin graft, 1:6 with sprayed cells; and ARM 3 will receive sprayed cells alone without meshed skin graft. The goal of this research is to assess the success of skin cell spray combined with a biocomposite subcutaneous (INTEGRA) layer for repair of large open wounds.
Source: Geneva Foundation via DOD
Term 03/15/2013 – 02/28/2015