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

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ClinicalTrials.gov Identifier: NCT01345591
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : May 12, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Facial Injuries
Adipose Tissue
Intervention Procedure: Fat Grafting
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fat Grafting
Hide Arm/Group Description fat grafting for facial trauma
Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Fat Grafting
Hide Arm/Group Description Fat Grafting for facial trauma
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
volume  
Mean (Standard Deviation)
Unit of measure:  Milliliters
Number Analyzed 20 participants
1.0  (0.0001)
tissue thickness  
Mean (Standard Deviation)
Unit of measure:  Milliliters
Number Analyzed 20 participants
0.352  (0.180)
1.Primary Outcome
Title Volume
Hide Description fat graft volume
Time Frame 3 months and 9 months post op.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fat Graft Volume at 3 Months Fat Graft Volume at 9 Months
Hide Arm/Group Description:
fat grafting for facial trauma, volume measured at 3 months post-op
fat grafting for facial trauma, volume measured at 9 months post-op
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: milliliters
0.576  (0.188) 0.621  (0.191)
2.Secondary Outcome
Title SWAP, COPE and CSQ-8
Hide Description 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.
Time Frame as assessed at baseline, 7-21 days, 3 months and 9 months post op.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fat Grafting_evaluation at Baseline Fat Grafting_7-21 Days Post op Fat Grafting_3 Months Post op Fat Grafting_9 Months Post-op
Hide Arm/Group Description:
quality of life measurement at baseline to include SWAP, COPE and CSQ-8 questionnaires
quality of life measurement at 7-21 days post-op to include SWAP, COPE and CSQ-8 questionnaires
quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires
quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
SWAP 59.7  (11.1) 57.8  (7.0) 57.9  (8.3) 56.3  (6.3)
COPE 57.1  (8.5) 56.8  (13.1) 54.4  (13.5) 55.1  (7.7)
CSQ-8 27.0  (2.9) 30.9  (2.4) 31.3  (2.2) 30.7  (2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fat Grafting
Hide Arm/Group Description fat grafting for facial trauma
All-Cause Mortality
Fat Grafting
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Fat Grafting
Affected / at Risk (%)
Total   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fat Grafting
Affected / at Risk (%)
Total   20/20 (100.00%) 
Surgical and medical procedures   
bruising  20/20 (100.00%) 
swelling at injection site  20/20 (100.00%) 
redness at injection site  20/20 (100.00%) 
Vascular disorders   
warmth  20/20 (100.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: J. Peter Rubin
Organization: University of Pittsburgh
Phone: 412-624-9703
EMail: rubipj@upmc.edu
Layout table for additonal information
Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01345591    
Other Study ID Numbers: PRO09060101
First Submitted: April 14, 2011
First Posted: May 2, 2011
Results First Submitted: November 14, 2016
Results First Posted: May 12, 2017
Last Update Posted: July 11, 2017