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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01822301
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Facial Injuries; Adipose Tissue	Procedure: Repeat Fat grafting	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. Facial Volume Score [assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op]

   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

1. Serial Computed Tomography Imaging [assessed at 7-21 days, 3 months and 9 months post op.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Unversity of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• United States Department of Defense

Investigators

• Principal Investigator: Joseph P Rubin, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

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• 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
• Other Study ID Numbers: PRO12100585
• First Posted: Apr 2, 2013
• Last Update Posted: Jul 11, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by J. Peter Rubin, MD, Founding Chair Department of Plastic Surgery Professor of Surgery at the University of Pittsburgh School of Medicine, University of Pittsburgh: Craniomaxillofacial (CMF) Battle-injured (BI); Facial Trauma; Fat Grafts; Autogenous Fat Transfers (AFT); Wounded warriors
• Additional relevant MeSH terms: Facial Injuries

Study Results

Participant Flow

Recruitment Details	Recruitment will come from subjects who have successfully completed IRB# PRO09060101 entitled "Structural Fat Grafting for Craniofacial Trauma". These subjects have expressed a strong desire to participate in this study and have been asked to sign the Research Registry IRB#PRO07050333.

Arm/Group Title	Repeat Facial Fat Grafting
Arm/Group Description	Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Repeat Facial Fat Grafting
Arm/Group Description	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. We treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. .
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	3 60%
Male	2 40%
Region of Enrollment (Count of Participants)
United States	5 100%
Serial computer tomography imaging (Count of Participants)
Count of Participants [Participants]	3 60%

Outcome Measures

1. Primary Outcome

Title	Facial Volume Score
Description	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.
Time Frame	assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Facial Volume Score at Baseline	Facial Volume Score at 7-21 Day PO	Facial Volume Score at 3 Month PO	Facial Volume Score at 9 Months PO
Arm/Group Description	facial volume score at baseline, pre-op	facial volume score at 7-21 days post-operation	facial volume score at 3 months post-operation	facial volume score at 3 months post-operation
Measure Participants	5	5	5	5
Mean (Standard Deviation) [units on a scale]	1.8 (0.4)	2.2 (0.5)	2.2 (0.4)	2.6 (0.5)

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT Imaging at 7-21 Days PO	CT Imaging at 3 Months PO	CT Imaging at 9 Months PO
Arm/Group Description	CT imaging at 7-21 days post-operation	CT imaging at 3 months post-operation	CT imaging at 9 months post-operation
Measure Participants	3	3	1
Mean (Standard Deviation) [volume, mL]	15 (12.3)	10.3 (9.1)	12.4 (NA)

Adverse Events

Arm/Group Title	Repeat Facial Fat Grafting
Arm/Group Description	Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
All Cause Mortality
	Repeat Facial Fat Grafting
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Repeat Facial Fat Grafting
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Repeat Facial Fat Grafting
	Affected / at Risk (%)	# Events
Total	5/5 (100%)
Surgical and medical procedures
bruising	5/5 (100%)	5
swelling	5/5 (100%)	5
pain	5/5 (100%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.