Facial InjuriesBTI++NCT02267187

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

A study testing Fat Grafting, General Anesthesia and Coleman Cannulas in people with Facial Injuries, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Facial Injuries
What is being tested?: Fat Grafting, General Anesthesia and Coleman Cannulas
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 22 Oct 2014to 21 Jun 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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.

Read the 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.

Conditions: Facial Injuries
Being tested: Fat Grafting, General Anesthesia, Coleman Cannulas, Tefla non-adherent gauze pad
Keywords: Craniomaxillofacial (CMF), Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded Warriors
Medical subject headings: Facial Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fat GraftingProcedure or surgery
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.
General AnesthesiaDrug
A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.
Coleman CannulasDevice
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.
Tefla non-adherent gauze padOther
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.

Study groups in NCT02267187
Study group	Role	What they receive
Fat Graftting	Experimental	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. Receives: Procedure: Fat Grafting; Drug: General Anesthesia; Device: Coleman Cannulas; Other: Tefla non-adherent gauze pad

What is being measured

The primary outcome is the main question the study is designed to answer.

Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.
Measured: Assessed at 7-21 days, 3 months, 9 months
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.
Measured: screen, 7-21 days, 3, and 9 months post-operative

Secondary outcomes (1)

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.
Measured: Assessed at time of operative procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 201421 Jun 2017

First posted17 Oct 2014 (estimated)
Study start22 Oct 2014
Primary completion21 Jun 2017
Study completion21 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Facial InjuriesStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02267187
Sponsor's protocol ID: PRO14040197
Acronym: BTI++
Status last verified: Jun 2018
First submitted: 8 Aug 2014
Last updated: 24 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: 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.

Publications

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.
PubMed 30985369

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Facial Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
ClinicalTrials.gov ID: NCT02267187
Acronym / sponsor ID: BTI++ / PRO14040197
Conditions: Facial Injuries
Keywords: Craniomaxillofacial (CMF), Battle-injured (BI), Facial Trauma, Fat Grafts, Autogenous Fat Transfers (AFT), Wounded Warriors
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 22 Oct 2014 (actual)
Primary completion: 21 Jun 2017 (actual)
Study completion: 21 Jun 2017 (actual)
First posted: 17 Oct 2014 (estimated)
Results: Posted 17 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fat Graftting	Experimental	Procedure: Fat Grafting, Drug: General Anesthesia, Device: Coleman Cannulas, Other: Tefla non-adherent gauze padFor 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fat GraftingFat 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.	Procedure or surgery	Fat Graftting
General AnesthesiaA medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.	Drug	Fat Graftting
Coleman CannulasThe 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.	Device	Fat Graftting
Tefla non-adherent gauze padThe 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.	Other	Fat Graftting

Primary outcome

Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.
Time frame: Assessed at 7-21 days, 3 months, 9 months
Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative.
Time frame: 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.

1 secondary outcome

Assessment of Cellular Properties of the Cells Within the Fat Graft
Time frame: Assessed at time of operative procedure

Results and safety

Results posted to the registry on 17 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cotton Rolling Fat Grafting	15	10

Primary outcome: Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.

Time frame: Assessed at 7-21 days, 3 months, 9 months. Mean (Standard Deviation). Unit: milliliters

Measure	Cotton Rolling Fat Grafting n = 10
7-21 days	11.4 (6.6)
3 months	7.4 (4.9)
9 months	6.5 (4.7)

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

Time frame: screen, 7-21 days, 3, and 9 months post-operative. Mean (Standard Deviation). Unit: units on FVAS scale

Measure	Cotton Rolling Fat Grafting n = 10
screen	1.0 (0.0)
7-21 days	2.6 (0.5)
3 months	2.2 (0.4)
9 months	2.2 (0.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7-21 days, 3 months, 9 months post-operatively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cotton Rolling Fat Grafting	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30985369Bourne 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph P Rubin, MD principal investigator

Professor of Plastic Surgery at the University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fat Grafting, General Anesthesia and Coleman Cannulas in people with Facial Injuries, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. (time frame: Assessed at 7-21 days, 3 months, 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02267187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.