Adipose Tissue, Facial Injuries
Conditions
Keywords
BTI, Craniomaxillofacial (CMF) Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded warriors
Brief summary
Injuries resulting in facial trauma are common, and can have devastating consequences on your quality of life. While the facial bones can often be reconstructed, physicians strive to find better ways to accurately restore injured facial features. In this clinical trial funded by the Department of Defense, the investigators are evaluating how effectively fat grafting can restore facial features, and how the filling effect of the fat graft lasts over time in participants with visible facial injuries. All procedures for this research study will be performed at the University of Pittsburgh Medical Center.
Detailed description
The purpose of this research is to evaluate how well the filling effect of the fat remains over time. A person's own fat may be used to improve the appearance of the body by moving it from an area where it is less needed. This is called fat grafting, and it is a common procedure, performed approximately 65,000 times by plastic surgeons in the United State last year. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost volume or fullness due to aging, trauma, surgery, birth defects, or other causes. Typically, the transferred fat results in an increase in volume of the body site being treated. Fat grafting is a minimally invasive surgical procedure in which a person's own fat may be used to improve the appearance of the body by moving it from an area where it is less needed. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost shape or fullness due to injury. This procedure is performed through very small incisions that allow a hollow tube to pass through. Fat grafting is a common cosmetic and reconstructive procedure. It was performed approximately 65,000 times by plastic surgeons in the United States last year. Typically, the transferred fat results in an increase in volume and shape of the body site being treated. The investigators believe this clinical technique of fat grafting could be of significant benefit to patients with facial injuries. The fat grafting procedure being performed in this trial is considered to be research, but not an experimental procedure.
Interventions
PROCEDUREFat Grafting
Sponsors
United States Department of Defense
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older and able to provide informed consent 2. Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 5 and 150 cc of lipoaspirate 3. Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved 4. Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses 5. The three dimensional geometry of the volume defects would allow for treatment with lipoaspirate injection that in a manner that at least two distinct treated areas could be discerned on gross examination and radiographically (e.g. treated regions are on opposite sides of the face, on lower face versus upper face, or separated by a bony landmark such as zygoma. This would include the ability to treat an uninjured contralateral region with lipoaspirate in order to obtain symmetry. 6. Willing and able to comply with follow up examinations, including radiographic studies -
Exclusion criteria
1. Age less than 18 years 2. Inability to provide informed consent 3. Craniofacial defects intended for treatment have open wounds or communicate with oral cavity or sinus (note: presence of such a defect in the setting of another defect(s) that meets treatment criteria will not exclude the patient from participating). 4. Active infection anywhere in the body 5. Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment 6. Known coagulopathy 7. Pregnancy -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume | 3 months and 9 months post op. | fat graft volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SWAP, COPE and CSQ-8 | as assessed at baseline, 7-21 days, 3 months and 9 months post op. | three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fat Grafting Fat Grafting for facial trauma | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Fat Grafting |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
| tissue thickness | 0.352 milliliters STANDARD_DEVIATION 0.18 |
| volume | 1.0 milliliters STANDARD_DEVIATION 0.0001 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Volume
fat graft volume
Time frame: 3 months and 9 months post op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fat Graft Volume at 3 Months | Volume | 0.576 milliliters | Standard Deviation 0.188 |
| Fat Graft Volume at 9 Months | Volume | 0.621 milliliters | Standard Deviation 0.191 |
Secondary
SWAP, COPE and CSQ-8
three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.
Time frame: as assessed at baseline, 7-21 days, 3 months and 9 months post op.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fat Graft Volume at 3 Months | SWAP, COPE and CSQ-8 | SWAP | 59.7 units on a scale | Standard Deviation 11.1 |
| Fat Graft Volume at 3 Months | SWAP, COPE and CSQ-8 | CSQ-8 | 27.0 units on a scale | Standard Deviation 2.9 |
| Fat Graft Volume at 3 Months | SWAP, COPE and CSQ-8 | COPE | 57.1 units on a scale | Standard Deviation 8.5 |
| Fat Graft Volume at 9 Months | SWAP, COPE and CSQ-8 | SWAP | 57.8 units on a scale | Standard Deviation 7 |
| Fat Graft Volume at 9 Months | SWAP, COPE and CSQ-8 | CSQ-8 | 30.9 units on a scale | Standard Deviation 2.4 |
| Fat Graft Volume at 9 Months | SWAP, COPE and CSQ-8 | COPE | 56.8 units on a scale | Standard Deviation 13.1 |
| Fat Grafting_3 Months Post op | SWAP, COPE and CSQ-8 | COPE | 54.4 units on a scale | Standard Deviation 13.5 |
| Fat Grafting_3 Months Post op | SWAP, COPE and CSQ-8 | SWAP | 57.9 units on a scale | Standard Deviation 8.3 |
| Fat Grafting_3 Months Post op | SWAP, COPE and CSQ-8 | CSQ-8 | 31.3 units on a scale | Standard Deviation 2.2 |
| Fat Grafting_9 Months Post-op | SWAP, COPE and CSQ-8 | SWAP | 56.3 units on a scale | Standard Deviation 6.3 |
| Fat Grafting_9 Months Post-op | SWAP, COPE and CSQ-8 | CSQ-8 | 30.7 units on a scale | Standard Deviation 2.4 |
| Fat Grafting_9 Months Post-op | SWAP, COPE and CSQ-8 | COPE | 55.1 units on a scale | Standard Deviation 7.7 |