Principal Investigator: J. Peter Rubin, MD, FACS
Organization: University of Pittsburgh
Injuries to the face and head are very common in our military personnel, with nearly 40% of battlefield injuries occurring above the neck. These injuries, especially related to explosive blasts, are severely disfiguring and significantly impair the ability of our war fighters to integrate back into society and military service. While surgical specialists treating face and skull trauma have become skilled at repairing the bony structures, it is the configuration of the skin and soft tissues over the bony skeleton that provides the recognizable human appearance. Therefore, restoring those tissues is paramount in helping our wounded warriors restore a more normal facial form and reintegrate into military and civilian society. Unfortunately, some of our best and most advanced surgical techniques for restoring soft tissue of the face lack precision in restoring facial features. These techniques include moving tissues such as muscle and skin from other parts of the body and reconnecting the blood supply using a microscope. In prior Department of Defense funded clinical trials work, the principal investigator of this proposal validated a minimally invasive technique for restoring facial features in wounded patients using injectable fat tissue taken from another part of the body in the same patient. In this technique, a narrow liposuction tube is used to extract small particles of fat tissue from under the skin of the abdomen. This living fat tissue is then immediately injected into the injured facial tissues using specialized instrumentation and can be injected in very precise locations and volumes. While this technique results regeneration of a patient’s own tissue to precisely restore features, a major problem with fat grafting is that approximately 35 to 40% of the injected tissue volume will be lost during the initial healing. By three months after the procedure, the remaining tissue is well healed and will retain its shape and size. Therefore, we have found that optimal results are achieved if a repeat fat grafting procedure is performed.
In this clinical trial, we will enroll and treat 22 patients with deformities from facial trauma using two sequential fat grafting procedures spaced 3 months apart. We will study a process in which we remove extra fat tissue during the first fat grafting procedure and store the tissue in a medical freezer for later use. In the second procedure, we will inject the frozen preserved fat tissue. Prior clinical studies and our experimental data show that the fat can heal as well as fresh fat if the right storage conditions are used. The rationale for performing this study is that a majority of the operative time and a majority of the postoperative pain and discomfort is related to the fat harvest. Once a surgeon is in the operating room and actively harvesting fat, the added time to take some additional fat material for later use is incrementally small. The benefits of this strategy are that the second procedure will require less time, less anesthesia (even just local anesthesia), less discomfort and pain, less risk, and less cost to the healthcare system. We will study outcomes including facial appearance, volume of the grafted fat tissue with CT scans, pain levels reported by the patient postoperatively, pain medication usage postoperatively, and comparative cost of the procedures. We will also analyze properties of the fat tissue in the laboratory and study whether those biologic properties impact ability to heal when grafted. We will similarly study the medical profile of the patient and attempt to identify factors that may impact the quality of healing of the fat tissue. Additionally, we will biopsy fresh and frozen fat grafts from each patient and compare the quality of healing by pathology analysis.
If successful, this procedure would be broadly applicable throughout the military, veteran, and civilian population. Anyone who has suffered trauma to the face and head with a remaining visible deformity could be a candidate for this procedure, and therefore this work would have a high impact.