A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury

Adipose Tissue Clinical Trial

— BTI  

Official title:

Structural Fat Grafting for Craniofacial Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345591
• Other study ID #: PRO09060101
• Status: Completed
• Phase: N/A
• First received: April 14, 2011
• Last updated: May 10, 2017
• Start date: September 2009
• Est. completion date: August 2014

Study information

• Verified date: May 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Adipose Tissue
• Facial Injuries
• Facies

Intervention

Procedure:
• Fat Grafting

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (3)

Burnouf M, Buffet M, Schwarzinger M, Roman P, Bui P, Prévot 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. — View Citation

Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. — View Citation

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):323-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume	fat graft volume	3 months and 9 months post op.
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.	as assessed at baseline, 7-21 days, 3 months and 9 months post op.