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| Name | Class |
|---|---|
| Armed Forces Institute of Regenerative Medicine | FED |
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The goal of this clinical trial is to validate the safety and effectiveness of a two-stage approach for minimally invasive craniofacial soft tissue reconstruction using autologous fat grafting in wounded service members and veterans. The main questions it aims to answer are:
Researchers will compare results from the second-stage cryopreserved fat grafting to fresh fat grafting to assess outcomes like volume retention, patient recovery, and cost reduction.
Participants will:
Undergo an initial fat grafting procedure. Have additional fat harvested and cryo-stored for use in a second-stage procedure.
Receive the cryopreserved fat in a later stage without the need for a second fat harvest.
Receive small test injections behind each ear for later analysis. Provide data on demographics and medical conditions for correlation with outcomes.
Craniofacial injuries are common among wounded service members, with 22.7% to 39% of battle injuries affecting the cranio-maxillofacial region. Restoring appearance requires precise soft tissue reconstruction. This proposal aims to address that need using a minimally invasive approach that uses the patient's own tissue, building on previous successful DoD-funded clinical trials.
Autologous fat grafting (AFG) is a common, minimally invasive procedure used in plastic surgery to restore facial volume. In a prior department of defense funded trial, the study investigators demonstrated its safety and effectiveness for repairing traumatic craniofacial deformities. However, about 37% of the grafted fat is reabsorbed during early healing, requiring multiple procedures for optimal results. The donor site harvest is the main source of discomfort, time, and cost in these procedures.
The study investigators propose improving this process by harvesting extra fat during the first procedure, cryo-storing it, and using the preserved fat for a second stage without needing another harvest. This approach will be validated using outcome measures from prior work. Additionally, the investigators are working with a commercial partner to advance a low-cost kit for cryo-storing fat at medical facilities, including military treatment centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Intervention | Experimental | The therapeutic intervention is a two stage surgical procedure (with a third stage biopsy for research purposes in this trial) in which a primary traumatic or post-surgical craniofacial deformity is treated first with autologous fat grafting using freshly harvested adipose tissue. A second fat grafting procedure is performed at 3.0 months after the first procedure using autologous adipose tissue that had been cryopreserved during the first procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serial Fat Grafting Fresh followed by Cryopreserved Fat | Procedure | The therapeutic intervention is a two stage surgical procedure (with a third stage biopsy for research purposes in this trial) in which a primary traumatic or post-surgical craniofacial deformity is treated first with autologous fat grafting using freshly harvested adipose tissue. A second fat grafting procedure is performed at 3.0 months after the first procedure using autologous adipose tissue that had been cryopreserved during the first procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Facial volume and appearance scale | This is a validated visual 3-point grading scale that will be scored by 4 blinded observers (2 physicians and 2 lay-observers) from standardized photographs The definitions for each of three points on the scale are listed here: a score of 1 means: for baseline grading of a given facial aesthetic region assessed there is an obvious contour defect that would benefit from volume fill. For post-treatment grading, no discernable improvement from baseline. A score of 2 means: for a given facial aesthetic region with a history of a traumatic deformity and treatment of the deformity according to the study protocol, there is a discernable improvement in the contour defect from baseline which does not yet approximate the contralateral side (if uninjured) or represent a normal appearance. A score of 3 means: for a given facial aesthetic region there is a normal appearance and/or close to matching contralateral structure (if uninjured). | The key timepoint is 3 months post-graft. The difference between the Facial Volume and Appearance Scale scores from the Pre-treatment baseline to the 3-months post-1st treatment, for each subject, will be generated. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of adverse events will be counted, as well as a subscore for those adverse events that are considered related to the study intervention. | From intervention to the final study visit (3 months post 2nd treatment, or approximately 6 months after initial intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleanor Shirley, MA, CCRC | Contact | 412-624-2376 | shirleye@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| J. Peter Rubin | University of Pittsburgh | Principal Investigator |
| Patsy Simon, BS, RN, CCRC, CCRA, ACRP-PM | Director, Operations and Administration | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15261 | United States |
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The therapeutic intervention is a two stage surgical procedure (with a third stage biopsy for research purposes in this trial) in which a primary traumatic or post-surgical craniofacial deformity is treated first with autologous fat grafting using freshly harvested adipose tissue. A second fat grafting procedure is performed at 3.0 months after the first procedure using autologous adipose tissue that had been cryopreserved during the first procedure.
Facial volume and appearance will be scored by 4 blinded observers (2 physicians and 2 lay-observers) from standardized photographs.
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| Change in facial injury volume from Pre to Post CT Scans- within each subject- High resolution Computed Tomography with 3D reconstruction (CT) will be performed. | Craniofacial fine cut CT with 3D reconstruction & volume analysis. 5 CTs of the face will be done on each subject. The first scan will be pre-procedural and will serve as a baseline. All CT scans will be done on a 64-slice scanner (LightSpeed, GE Healthcare), using collimation of 0.625mm and slice interval of 0.3mm, resulting in approximately 50% overlap between adjacent slices. kVp, mA, and FOV will be optimized to the subject, but will approximately be kVp=120; mA=320, FOV=18cm. Soft tissue and bone kernels will be employed. These images will be volumetrically reformatted into coronal and sagittal planes for confirmation of findings. Additionally, surface-rendered volumetric reformats will be created emphasizing both bony structures and soft tissues. Images will be reviewed by a dedicated head and neck radiologist with 25 years of experience in CT of the face. | Facial volume analysis of the injured area will be calculated from the individual CTs, comparing from each subject's pretreatment baseline to the final study visit (3 months post 2nd treatment, or approximately 6 months after initial intervention) |