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Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material (BTI++)

Primary Purpose

Facial Injuries

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fat Grafting

General Anesthesia

Coleman Cannulas

Tefla non-adherent gauze pad

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
Who are post injury and/or post surgery (e.g. tx of aneurism, intercranial bleed, and tumor resections that do not involve radiation and would be analogous to trauma population requiring craniotomy) resulting in craniofacial volume defect 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
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
Subjects with an Axis I DSM-IV diagnosis (e.g., Schizophrenia, Bipolar disorder) who are found to be clinically (i.e. medically) unstable at baseline. Individuals who manifest either: 1) evidence of currently active alcohol or psychoactive drug abuse or dependence on the SCID interview, or 2) a GAF score of 40 or lower due to any acute psychiatric symptomatology (e.g. suicidality, psychosis, severe depression or mania) will be reviewed by the Co-I for Psychosocial Assessment with the PI for determination of possible medical instability. Final determination of medically unstable status will be made by the PI on the basis of overall medical status and appropriateness for medical procedures; the patient may be considered ineligible for study participation per the Physician's discretion

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fat Graftting

Arm Description

For the purpose of this study the fat grafting procedure is a research procedure. It is very important to note that this research procedure is not an experimental procedure. 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 known as a filler providing an accurate means to restoring facial soft tissue structure.

Outcomes

Primary Outcome Measures

Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.

Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative.

Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance.

Secondary Outcome Measures

Assessment of Cellular Properties of the Cells Within the Fat Graft

Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft.

Full Information

NCT ID

NCT02267187

First Posted

August 8, 2014

Last Updated

June 26, 2018

Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT02267187

Brief Title

Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material

Acronym

BTI++

Official Title

Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

October 22, 2014 (Actual)

Primary Completion Date

June 21, 2017 (Actual)

Study Completion Date

June 21, 2017 (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

This study will examine the impact of the fat grafting procedure on facial appearance and quality of life over time by precisely measuring soft tissue volume with CT scans, assessing appearance with 2D and 3D photography and standard photography and evaluating quality of life through various validated psychosocial measures. This study will be a very important evaluation of the effectiveness of this therapy, and will help guide clinicians in applying this technique. Additionally, laboratory testing of the injected fat material will be performed so that the results may be correlated with clinical outcomes in the future. The study endpoints include the analysis of the graft site via study procedures at different time points, the comparison of cotton rolling to centrifugation method of autologous fat grafting, as well as the correlation of cell behavior of the laboratory assays with clinical outcomes.

Detailed Description

Clinical use of autologous fat grafting in humans was described as early as 1893, when Neuber published his report of transferring multiple small particles of fat to fill a soft tissue depression. Over the past three decades, autologous fat grafting has become a common procedure in clinical plastic surgery, and is also employed by clinicians in other specialties. The refinement of liposuction techniques in the 1980's made it possible to harvest the adipose grafts with low risk and without the need for a significant incision. The liposuction aspirate could simply be reinjected at a different site. Specialized equipment has been developed for fat grafting and is commercially available from a number of sources. The American Society of Plastic Surgeons 2007 procedural statistics show that over 65,000 fat grafting procedures were performed in the United States (www.plasticsurgery.org) during the previous year. Fat grafting may represent a superior method of facial reconstruction after severe trauma, but the results can be impacted by resorption of fat volume over time. The specific aims of the study are: Assess facial appearance and soft tissue volume before and after autologous fat grafting using CT scans and 3D photography. Assess cellular properties of the cells within the fat graft Comparison of cotton rolling to centrifugation method of autologous fat grafting Measure of quality of life in patients before and after autologous fat grafting using validated psychosocial measures. Ten (10) subjects 18 years of age and older will be enrolled to this trial.

6. Conditions and Keywords

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

Facial Injuries

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

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fat Graftting

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Fat Grafting

Intervention Description

Fat Grafting is a procedure that involves moving a person's own fat from an area of the body where it is less needed to another area of the body to improve its appearance. 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.

Intervention Type

Drug

Intervention Name(s)

General Anesthesia

Intervention Description

A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.

Intervention Type

Device

Intervention Name(s)

Coleman Cannulas

Intervention Description

The plastic surgeon, will use small narrow tube-like instruments called cannulas, will remove fat from various places throughout the body (commonly the abdomen and thighs). The plastic surgeon will then use the Coleman cannulas (specialized smaller cannulas with varied shapes and tip sizes specifically made to deliver smaller amounts of fat) to fill the desired area.

Intervention Type

Other

Intervention Name(s)

Tefla non-adherent gauze pad

Intervention Description

The processing of the fat graft material is done using a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component.

Primary Outcome Measure Information:

Title

Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.

Time Frame

Assessed at 7-21 days, 3 months, 9 months

Title

Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative.

Description

Time Frame

screen, 7-21 days, 3, and 9 months post-operative

Secondary Outcome Measure Information:

Title

Assessment of Cellular Properties of the Cells Within the Fat Graft

Description

Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft.

Time Frame

Assessed at time of operative procedure

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 Who are post injury and/or post surgery (e.g. tx of aneurism, intercranial bleed, and tumor resections that do not involve radiation and would be analogous to trauma population requiring craniotomy) resulting in craniofacial volume defect 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 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 Subjects with an Axis I DSM-IV diagnosis (e.g., Schizophrenia, Bipolar disorder) who are found to be clinically (i.e. medically) unstable at baseline. Individuals who manifest either: 1) evidence of currently active alcohol or psychoactive drug abuse or dependence on the SCID interview, or 2) a GAF score of 40 or lower due to any acute psychiatric symptomatology (e.g. suicidality, psychosis, severe depression or mania) will be reviewed by the Co-I for Psychosocial Assessment with the PI for determination of possible medical instability. Final determination of medically unstable status will be made by the PI on the basis of overall medical status and appropriateness for medical procedures; the patient may be considered ineligible for study participation per the Physician's discretion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph P Rubin, MD

Organizational Affiliation

Professor of Plastic Surgery at the University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University 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 information de-identified available to secondary investigators (investigators not listed on the front page of this consent document) after all research study testing has been completed. These stored samples and associated subject information will not include subject identifiers.

Citations:

PubMed Identifier

30985369

Citation

Bourne DA, Bliley J, James I, Donnenberg AD, Donnenberg VS, Branstetter BF 4th, Haas GL, Radomsky E, Meyer EM, Pfeifer ME, Brown SA, Marra KG, Coleman S, Rubin JP. Changing the Paradigm of Craniofacial Reconstruction: A Prospective Clinical Trial of Autologous Fat Transfer for Craniofacial Deformities. Ann Surg. 2021 May 1;273(5):1004-1011. doi: 10.1097/SLA.0000000000003318.

Results Reference

derived

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Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material

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