Trial Outcomes & Findings for A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury (NCT NCT01345591)

Results Overview

fat graft volume

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

3 months and 9 months post op.

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Fat Grafting fat grafting for facial trauma
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Fat Grafting fat grafting for facial trauma
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fat Grafting n=20 Participants Fat Grafting for facial trauma
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
volume	1.0 milliliters STANDARD_DEVIATION 0.0001 • n=5 Participants
tissue thickness	0.352 milliliters STANDARD_DEVIATION 0.180 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months and 9 months post op.

fat graft volume

Outcome measures

Outcome measures
Measure	Fat Graft Volume at 3 Months n=19 Participants fat grafting for facial trauma, volume measured at 3 months post-op	Fat Graft Volume at 9 Months n=19 Participants fat grafting for facial trauma, volume measured at 9 months post-op	Fat Grafting_3 Months Post op quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires	Fat Grafting_9 Months Post-op quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
Volume	0.576 milliliters Standard Deviation 0.188	0.621 milliliters Standard Deviation 0.191	—	—

SECONDARY outcome

Timeframe: as assessed at baseline, 7-21 days, 3 months and 9 months post op.

three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.

Outcome measures

Outcome measures
Measure	Fat Graft Volume at 3 Months n=20 Participants fat grafting for facial trauma, volume measured at 3 months post-op	Fat Graft Volume at 9 Months n=20 Participants fat grafting for facial trauma, volume measured at 9 months post-op	Fat Grafting_3 Months Post op n=20 Participants quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires	Fat Grafting_9 Months Post-op n=20 Participants quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
SWAP, COPE and CSQ-8 SWAP	59.7 units on a scale Standard Deviation 11.1	57.8 units on a scale Standard Deviation 7.0	57.9 units on a scale Standard Deviation 8.3	56.3 units on a scale Standard Deviation 6.3
SWAP, COPE and CSQ-8 COPE	57.1 units on a scale Standard Deviation 8.5	56.8 units on a scale Standard Deviation 13.1	54.4 units on a scale Standard Deviation 13.5	55.1 units on a scale Standard Deviation 7.7
SWAP, COPE and CSQ-8 CSQ-8	27.0 units on a scale Standard Deviation 2.9	30.9 units on a scale Standard Deviation 2.4	31.3 units on a scale Standard Deviation 2.2	30.7 units on a scale Standard Deviation 2.4

Adverse Events

Fat Grafting

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fat Grafting n=20 participants at risk fat grafting for facial trauma
Surgical and medical procedures bruising	100.0% 20/20
Surgical and medical procedures swelling at injection site	100.0% 20/20
Vascular disorders warmth	100.0% 20/20
Surgical and medical procedures redness at injection site	100.0% 20/20

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