Trial record 2 of 11 for:    Structural Fat Grafting

Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (BTI Plus Up)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01822301
First received: March 19, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Facial Injuries
Adipose Tissue
Procedure: Repeat Fat grafting

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The Change over time in the volume and contour of the fat graft site. [ Time Frame: Change over time as assessed at baseline; 7-21 days, 3 months and 9 months post op ] [ Designated as safety issue: Yes ]
    The investigators anticipate that additional fat graft treatment will fully restore the facial features and overcome fat loss from the initial fat graft treatment as assessed by CT scans and assessing appearance with 2D and 3D photography


Secondary Outcome Measures:
  • Examination of the cellular properties of the grafted material in each subject for future correlation with clinical outcomes [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    A secondary objective is to examine the cellular properties of the grafted material in each subject for future correlation with clinical outcomes

  • Change in time of Quality of life measures [ Time Frame: as assessed at baseline then 7-21 days, 3 months and 9 months post op. ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: April 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Repeat Facial fat grafting Procedure: Repeat Fat grafting
Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is considered a standard of care procedure in plastic surgery. In brief, fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula in the operating room. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the facial deformity using specialized injection cannulas. In this study, we will treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) with be used for comparison.

Detailed Description:

Facial trauma injuries, especially those sustained in military combat and severe automobile crashes, are characterized by destruction of bone and soft tissue anatomy. While the bony skeleton can often be reconstructed, the overlying soft tissue is difficult to restore.

Importantly, it is the structure of the soft tissue that imparts the normal human form, and adequate reconstruction of soft tissue defects allows trauma victims to reintegrate into society. Accepted procedures for soft tissue reconstruction of the face involve tissue flap reconstruction procedures and autologous fat grafting. Tissue flap operations are extensive, often including microvascular surgery, and do not precisely correct the deformities. Fat grafting is a less invasive technique that allows for more precise shaping of the reconstructed tissues. However, autologous fat grafts may undergo resorption that can affect the appearance of the reconstruction over time. The degree of change in appearance after fat grafting has not been well studied for facial trauma patients.

We hypothesize that subjects who have successfully completed participation in the study (PRO09060101) and experienced graft resorbtion will have improved outcomes with an additional fat graft treatment. We anticipate that additional fat graft treatment will fully restore the facial features and overcome fat loss from the initial fat graft treatment. Additionally, we hypothesize that the cellular properties of the fat precursor cells (preadipocytes) may correlate with fat graft retention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01822301

Locations
United States, Pennsylvania
Unversity of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: J Peter Rubin, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: J. Peter Rubin, MD, Founding Chair Department of Plastic Surgery Professor of Surgery at the University of Pittsburgh School of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01822301     History of Changes
Other Study ID Numbers: PRO12100585
Study First Received: March 19, 2013
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pittsburgh:
Craniomaxillofacial (CMF) Battle-injured (BI)
Facial Trauma
Fat Grafts
Autogenous Fat Transfers (AFT)
Wounded warriors

Additional relevant MeSH terms:
Facial Injuries
Craniocerebral Trauma
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014