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Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (BTIPlusUp)

Primary Purpose

Facial Injuries, Adipose Tissue

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Repeat Fat grafting

About this trial

This is an interventional treatment trial for Facial Injuries focused on measuring Craniomaxillofacial (CMF) Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded warriors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 lipaspirate in order to obtain symmetry.
Willing and able to comply with follow up examinations, including radiographic studies
Have completed participation in IRB# PRO09060101.

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
Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient.
Pregnancy
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.)

Sites / Locations

Unversity of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repeat Facial fat grafting

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Serial Computed Tomography Imaging

serial computed tomography images were collected to evaluate the volume of the defect

Full Information

NCT ID

NCT01822301

First Posted

March 19, 2013

Last Updated

June 9, 2017

Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT01822301

Brief Title

Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort

Acronym

BTIPlusUp

Official Title

Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Injuries, Adipose Tissue

Keywords

Craniomaxillofacial (CMF) Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded warriors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Repeat Facial fat grafting

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Repeat Fat grafting

Intervention Description

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.

Primary Outcome Measure Information:

Title

Facial Volume Score

Description

Time Frame

assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op

Secondary Outcome Measure Information:

Title

Serial Computed Tomography Imaging

Description

serial computed tomography images were collected to evaluate the volume of the defect

Time Frame

assessed at 7-21 days, 3 months and 9 months post op.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 lipaspirate in order to obtain symmetry. Willing and able to comply with follow up examinations, including radiographic studies Have completed participation in IRB# PRO09060101. 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 Systemic disease that would render the fat harvest and injection procedure, along with associated anesthesia, unsafe to the patient. Pregnancy 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph P Rubin, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Unversity of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

It is the Principal Investigator's intention to make stored samples and subject de-identified information available to secondary investigators after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.

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Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort

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