- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01345591
A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury (BTI)
Structural Fat Grafting for Craniofacial Trauma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 years or older and able to provide informed consent
- Have suffered injury resulting in craniofacial volume defects which could be treated with a graft volume of between 5 and 150 cc of lipoaspirate
- Be at least 3 months post-injury or post-surgery (from trauma procedures) so that acute edema is resolved
- Volume defects are covered by intact skin and do not communicate with oral cavity or sinuses
- 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.
- Willing and able to comply with follow up examinations, including radiographic studies -
Exclusion Criteria:
- Age less than 18 years
- Inability to provide informed consent
- 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).
- Active infection anywhere in the body
- Diagnosed with cancer within the last 12 months and /or presently receiving chemotherapy or radiation treatment
- Known coagulopathy
- Pregnancy -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fat Grafting
Twenty (20) subjects who have had severe facial trauma, 18 years of age and older enrolled to clinical trial will receive Fat grafting intervention procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume
Time Frame: 3 months and 9 months post op.
|
fat graft volume
|
3 months and 9 months post op.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SWAP, COPE and CSQ-8
Time Frame: 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.
|
as assessed at baseline, 7-21 days, 3 months and 9 months post op.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph P Rubin, MD, Associate Professor of Plastic Surgery at the University of Pittsburgh, Faculty appointment-McGowan Institute of Regenerative Medicine
Publications and helpful links
General Publications
- Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.
- Burnouf M, Buffet M, Schwarzinger M, Roman P, Bui P, Prevot M, Deleuze J, Morini JP, Franck N, Gorin I, Dupin N. Evaluation of Coleman lipostructure for treatment of facial lipoatrophy in patients with human immunodeficiency virus and parameters associated with the efficiency of this technique. Arch Dermatol. 2005 Oct;141(10):1220-4. doi: 10.1001/archderm.141.10.1220.
- Kaufman MR, Bradley JP, Dickinson B, Heller JB, Wasson K, O'Hara C, Huang C, Gabbay J, Ghadjar K, Miller TA. Autologous fat transfer national consensus survey: trends in techniques for harvest, preparation, and application, and perception of short- and long-term results. Plast Reconstr Surg. 2007 Jan;119(1):323-331. doi: 10.1097/01.prs.0000244903.51440.8c.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO09060101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Facial Injuries
-
University of UtahCompletedSynkinesis | Facial Asymmetry | Facial Nerve Injuries | Facial Paresis Associated With Facial Nerve Dysfunction
-
Johns Hopkins UniversityRecruitingFacial Injuries | Facial Deformity | Craniofacial Defects | Craniofacial Injuries | Traumatic Wounds and Injuries | Facial TransplantationUnited States
-
Massachusetts General HospitalNot yet recruitingFacial Injuries | Facial Deformity | Facial Trauma
-
NYU Langone HealthRecruitingFacial Injuries | Hand Injuries | Facial Deformity | Craniofacial Injuries | Upper Extremity Injuries | Face InjuriesUnited States
-
University of MichiganRecruitingFacial DefectUnited States
-
University of Texas at AustinCompletedFacial LacerationUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...UnknownInjury of Facial Nerve, Unspecified Side, Initial Encounter
-
David Grant U.S. Air Force Medical CenterWithdrawnFacial Injuries and Disorders
-
Children's Hospitals and Clinics of MinnesotaWithdrawnFacial and Scalp LacerationsUnited States
-
Recep Tayyip Erdogan UniversityActive, not recruitingLaser Therapy | Methylprednisolone | Nerve Injury | Facial Nerve InjuriesTurkey
Clinical Trials on Fat Grafting
-
Lawson Health Research InstituteNot yet recruitingBreast Asymmetry | Fat Atrophy
-
University College, LondonCompletedDiabetes Mellitus Foot UlcerUnited Kingdom
-
Melanie Salerno, RNLifespanUnknown
-
University of Texas Southwestern Medical CenterCompletedAcne Scars - Mixed Atrophic and Hypertrophic | AcneUnited States
-
University of PittsburghCompleted
-
Shanghai Jiao Tong University School of MedicineCompleted
-
Odense University HospitalCompletedHerpes Zoster | Post Herpetic NeuralgiaDenmark
-
Mayo ClinicWithdrawnBreast CancerUnited States
-
Mayo ClinicEnrolling by invitationBreast Reconstruction | Radiation Dermatitis | Radiation Fibrosis | Fat GraftingUnited States
-
University of PittsburghUnited States Department of DefenseTerminatedCraniofacial InjuriesUnited States