Trial Outcomes & Findings for Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (NCT NCT01822301)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

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

Results posted on

2017-07-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Repeat Facial Fat Grafting 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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Repeat Facial Fat Grafting n=5 Participants 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. .
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	5 Participants n=99 Participants
Serial computer tomography imaging	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Facial Volume Score at Baseline n=5 Participants facial volume score at baseline, pre-op	Facial Volume Score at 7-21 Day PO n=5 Participants facial volume score at 7-21 days post-operation	Facial Volume Score at 3 Month PO n=5 Participants facial volume score at 3 months post-operation	Facial Volume Score at 9 Months PO n=5 Participants facial volume score at 3 months post-operation
Facial Volume Score	1.8 units on a scale Standard Deviation 0.4	2.2 units on a scale Standard Deviation 0.5	2.2 units on a scale Standard Deviation 0.4	2.6 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Facial Volume Score at Baseline n=3 Participants facial volume score at baseline, pre-op	Facial Volume Score at 7-21 Day PO n=3 Participants facial volume score at 7-21 days post-operation	Facial Volume Score at 3 Month PO n=1 Participants facial volume score at 3 months post-operation	Facial Volume Score at 9 Months PO facial volume score at 3 months post-operation
Serial Computed Tomography Imaging	15 volume, mL Standard Deviation 12.3	10.3 volume, mL Standard Deviation 9.1	12.4 volume, mL Standard Deviation NA one participant analyzed	—

Adverse Events

Repeat Facial Fat Grafting

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Repeat Facial Fat Grafting n=5 participants at risk 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.
Surgical and medical procedures bruising	100.0% 5/5 • Number of events 5
Surgical and medical procedures swelling	100.0% 5/5 • Number of events 5
Surgical and medical procedures pain	100.0% 5/5 • Number of events 5

Additional Information

J. Peter Rubin

University of Pittsburgh

Phone: 412-624-9703

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place