Adipose Tissue Clinical Trial
— BTI Plus UpOfficial title:
Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
Verified date | May 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fat grafting represents a technique with great potential to improve outcomes in minimally
invasive facial reconstruction. Fat grafting has already been demonstrated as a safe and
minimally invasive technique over decades of widespread practice in plastic surgery. In our
current study of fat grafting for facial deformities (IRB# PRO09060101), we have treated 9
subjects without adverse event and all have had a significant improvement. Since all methods
of treatment and evaluation are the same in this study, we will be able to use the data in
our prior study as additional control data.
We hypothesize that repeating the fat grafting in subjects with previous facial fat grafts
will enable successful restoration of tissue volume and craniofacial form. Additionally, we
hypothesize that the results will be durable and subject quality of life improved.
Five (5) subjects (who were previously enrolled into IRB# PRO09060101) will be enrolled to
this single center University of Pittsburgh site research study.
Status | Completed |
Enrollment | 5 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
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 lipaspirate in order to obtain symmetry. 6. Willing and able to comply with follow up examinations, including radiographic studies 7. Have completed participation in IRB# PRO09060101. 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. Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient. 8. Pregnancy 9. Subjects with Schizophrenia, Bipolar Disorder. (Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion.) |
Country | Name | City | State |
---|---|---|---|
United States | Unversity of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | United States Department of Defense |
United States,
Balakrishnan C, Hashim M, Gao D. The effect of partial-thickness facial burns on social functioning. J Burn Care Rehabil. 1999 May-Jun;20(3):224-5. — View Citation
Berman M. Rejuvenation of the upper eyelid complex with autologous fat transplantation. Dermatol Surg. 2000 Dec;26(12):1113-6. — View Citation
Bisson JI, Shepherd JP, Dhutia M. Psychological sequelae of facial trauma. J Trauma. 1997 Sep;43(3):496-500. — View Citation
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
Cárdenas JC, Carvajal J. Refinement of rhinoplasty with lipoinjection. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):501-5. Epub 2007 Jul 25. — View Citation
Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. — View Citation
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. — View Citation
Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. — View Citation
Cortese A, Savastano G, Felicetta L. Free fat transplantation for facial tissue augmentation. J Oral Maxillofac Surg. 2000 Feb;58(2):164-9; discussion 169-70. — View Citation
Dasiou-Plakida D. Fat injections for facial rejuvenation: 17 years experience in 1720 patients. J Cosmet Dermatol. 2003 Jul;2(3-4):119-25. — View Citation
Domergue S, Psomas C, Yachouh J, Lesnik A, Reynes J, Goudot P, Jammet P. Fat microinfiltration autografting for facial restructuring in HIV patients. J Craniomaxillofac Surg. 2006 Dec;34(8):484-8. Epub 2006 Dec 8. — View Citation
Ellenbogen R, Motykie G, Youn A, Svehlak S, Yamini D. Facial reshaping using less invasive methods. Aesthet Surg J. 2005 Mar-Apr;25(2):144-52. doi: 10.1016/j.asj.2005.02.001. — View Citation
Ellenbogen R, Youn A, Yamini D, Svehlak S. The volumetric face lift. Aesthet Surg J. 2004 Nov-Dec;24(6):514-22. doi: 10.1016/j.asj.2004.08.006. — View Citation
Erol OO. Facial autologous soft-tissue contouring by adjunction of tissue cocktail injection (micrograft and minigraft mixture of dermis, fascia, and fat). Plast Reconstr Surg. 2000 Nov;106(6):1375-87; discussion 1388-9. — View Citation
Guaraldi G, Orlando G, De Fazio D, De Lorenzi I, Rottino A, De Santis G, Pedone A, Spaggiari A, Baccarani A, Borghi V, Esposito R. Comparison of three different interventions for the correction of HIV-associated facial lipoatrophy: a prospective study. Antivir Ther. 2005;10(6):753-9. — View Citation
Guerrerosantos J. Simultaneous rhytidoplasty and lipoinjection: a comprehensive aesthetic surgical strategy. Plast Reconstr Surg. 1998 Jul;102(1):191-9. — View Citation
Guyuron B, Majzoub RK. Facial augmentation with core fat graft: a preliminary report. Plast Reconstr Surg. 2007 Jul;120(1):295-302. — View Citation
Hu S, Zhang H, Feng Y, Yang Y, Han X, Han X, Zhong Y, Shi J. Introduction of an easy technique for purification and injection of autogenous free fat parcels in correcting of facial contour deformities. Ann Plast Surg. 2007 Jun;58(6):602-7. — View Citation
Kanchwala SK, Holloway L, Bucky LP. Reliable soft tissue augmentation: a clinical comparison of injectable soft-tissue fillers for facial-volume augmentation. Ann Plast Surg. 2005 Jul;55(1):30-5; discussion 35. — View Citation
Karabulut AB, Tümerdem B. Obtaining predictable results in malar augmentation with preimplant fat injection. Plast Reconstr Surg. 2004 Dec;114(7):1974-5. — 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
Kuran I, Tumerdem B. A new simple method used to prepare fat for injection. Aesthetic Plast Surg. 2005 Jan-Feb;29(1):18-22; discussion 23. Epub 2005 Mar 10. — View Citation
Lawrence J, Heinberg LJ, Roca A, Munster AM, Fauerbach JA. Development and validation of the Satisfaction with Appearance Scale: assessing body image among burn-injured patients. Psychological Assessment 1998; 10: 64-70.
Levine E, Degutis L, Pruzinsky T, Shin J, Persing JA. Quality of life and facial trauma: psychological and body image effects. Ann Plast Surg. 2005 May;54(5):502-10. — View Citation
Macgregor FC. Facial disfigurement: problems and management of social interaction and implications for mental health. Aesthetic Plast Surg. 1990 Fall;14(4):249-57. — View Citation
Moseley TA, Zhu M, Hedrick MH. Adipose-derived stem and progenitor cells as fillers in plastic and reconstructive surgery. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):121S-128S. Review. — View Citation
Narins RS, Tope WD, Pope K, Ross EV. Overtreatment effects associated with a radiofrequency tissue-tightening device: rare, preventable, and correctable with subcision and autologous fat transfer. Dermatol Surg. 2006 Jan;32(1):115-24. — View Citation
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. — View Citation
Perry S, Difede J, Musngi G, Frances AJ, Jacobsberg L. Predictors of posttraumatic stress disorder after burn injury. Am J Psychiatry. 1992 Jul;149(7):931-5. — View Citation
Pontius AT, Williams EF 3rd. The evolution of midface rejuvenation: combining the midface-lift and fat transfer. Arch Facial Plast Surg. 2006 Sep-Oct;8(5):300-5. — View Citation
Procidano ME, Heller K. Measures of perceived social support from friends and from family: three validation studies. Am J Community Psychol. 1983 Feb;11(1):1-24. — View Citation
Reiche-Fischel O, Wolford LM, Pitta M. Facial contour reconstruction using an autologous free fat graft: a case report with 18-year follow-up. J Oral Maxillofac Surg. 2000 Jan;58(1):103-6. — View Citation
Robinson E, Rumsey N, Partridge J. An evaluation of the impact of social interaction skills training for facially disfigured people. Br J Plast Surg. 1996 Jul;49(5):281-9. — View Citation
Rosenberg, M. (1979). Conceiving the self. NY: Basic Books
Sadick NS, Hudgins LC. Fatty acid analysis of transplanted adipose tissue. Arch Dermatol. 2001 Jun;137(6):723-7. — View Citation
Sardesai MG, Moore CC. Quantitative and qualitative dermal change with microfat grafting of facial scars. Otolaryngol Head Neck Surg. 2007 Dec;137(6):868-72. — View Citation
Sarwer DB, Crerand CE. Body image and cosmetic medical treatments. Body Image. 2004 Jan;1(1):99-111. — View Citation
Serra-Renom JM, Fontdevila J. Treatment of facial fat atrophy related to treatment with protease inhibitors by autologous fat injection in patients with human immunodeficiency virus infection. Plast Reconstr Surg. 2004 Aug;114(2):551-5; discussion 556-7. — View Citation
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. — View Citation
Thompson A, Kent G. Adjusting to disfigurement: processes involved in dealing with being visibly different. Clin Psychol Rev. 2001 Jul;21(5):663-82. Review. — View Citation
Valente SM. Visual disfigurement and depression. Plast Surg Nurs. 2009 Jan-Mar;29(1):10-6; quiz 17-8. doi: 10.1097/01.PSN.0000347718.75285.23. — View Citation
Wallis H, Renneberg B, Ripper S, Germann G, Wind G, Jester A. Emotional distress and psychosocial resources in patients recovering from severe burn injury. J Burn Care Res. 2006 Sep-Oct;27(5):734-41. — View Citation
Ware J, Kosinski M, Keller S. SF-36 Physical and mental heatlh summary scales: A users manual. 2nd ed. Boston: New England Medical Center, 1994
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation
Watson D, Friend R. Measurement of social-evaluative anxiety. J Consult Clin Psychol. 1969 Aug;33(4):448-57. — View Citation
Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. The PTSD Checklist: Reliability, validity and diagnostic utility. Paper presented at the Annual Meeting of the International Society for Traumatic Stress Studies; 1993, San Antonio, TX.
Weissman MM, Bothwell S. Assessment of social adjustment by patient self-report. Arch Gen Psychiatry. 1976 Sep;33(9):1111-5. — View Citation
Yee A, Adjei N, Do J, Ford M, Finkelstein J. Do patient expectations of spinal surgery relate to functional outcome? Clin Orthop Relat Res. 2008 May;466(5):1154-61. doi: 10.1007/s11999-008-0194-7. Epub 2008 Mar 18. — View Citation
* Note: There are 48 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Facial Volume Score | the facial volume and appearance grading scale evaluates each aesthetic region in the face based on both physical examination and 3D photography by the clinician. scale ranges from 1-3 where a score of 1 indicates an obvious contour defect; 2 shows a noticeable improvement in contour but not sufficient to impart a normal appearance; 3 represents a normal appearance and/or close approximation with a normal uninjured contralateral structure. | assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op | |
Secondary | Serial Computed Tomography Imaging | serial computed tomography images were collected to evaluate the volume of the defect | assessed at 7-21 days, 3 months and 9 months post op. |
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