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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345591
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : May 12, 2017
Last Update Posted : July 11, 2017
United States Department of Defense
Information provided by (Responsible Party):
J. Peter Rubin, MD, University of Pittsburgh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Facial Injuries
Adipose Tissue
Intervention: Procedure: Fat Grafting

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Fat Grafting fat grafting for facial trauma

Participant Flow:   Overall Study
    Fat Grafting
Lost to Follow-up                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Fat Grafting Fat Grafting for facial trauma

Baseline Measures
   Fat Grafting 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      20 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      8  40.0% 
Male      12  60.0% 
[Units: Milliliters]
Mean (Standard Deviation)
 1.0  (0.0001) 
tissue thickness 
[Units: Milliliters]
Mean (Standard Deviation)
 0.352  (0.180) 

  Outcome Measures

1.  Primary:   Volume   [ Time Frame: 3 months and 9 months post op. ]

2.  Secondary:   SWAP, COPE and CSQ-8   [ Time Frame: as assessed at baseline, 7-21 days, 3 months and 9 months post op. ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information