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Trial record 1 of 1 for:    15985788 [PUBMED-IDS]
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Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (BTIPlusUp)

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ClinicalTrials.gov Identifier: NCT01822301
Recruitment Status : Completed
First Posted : April 2, 2013
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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Facial Injuries
Adipose Tissue
Intervention Procedure: Repeat Fat grafting
Enrollment 5
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.
Pre-assignment Details  
Arm/Group Title Repeat Facial Fat Grafting
Hide 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
Arm/Group Title Repeat Facial Fat Grafting
Hide 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 Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years 0
Between 18 and 65 years 5
>=65 years 0
[1]
Measure Description: 18 years or older
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
Serial computer tomography imaging  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
3
  60.0%
1.Primary Outcome
Title Facial Volume Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 3 3 1
Mean (Standard Deviation)
Unit of Measure: volume, mL
15  (12.3) 10.3  (9.1) 12.4 [1]   (NA)
[1]
one participant analyzed
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Repeat Facial Fat Grafting
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Repeat Facial Fat Grafting
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Repeat Facial Fat Grafting
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Surgical and medical procedures   
bruising  5/5 (100.00%)  5
swelling  5/5 (100.00%)  5
pain  5/5 (100.00%)  5
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: J. Peter Rubin
Organization: University of Pittsburgh
Phone: 412-624-9703
Publications:
Weathers FW, Litz BT, Herman DS, Huska JA, Keane TM. The PTSD Checklist: Reliability, validity and diagnostic utility. Paper presented at the Annual Meeting of the International Society for Traumatic Stress Studies; 1993, San Antonio, TX.
Rosenberg, M. (1979). Conceiving the self. NY: Basic Books
Ware J, Kosinski M, Keller S. SF-36 Physical and mental heatlh summary scales: A users manual. 2nd ed. Boston: New England Medical Center, 1994
Lawrence J, Heinberg LJ, Roca A, Munster AM, Fauerbach JA. Development and validation of the Satisfaction with Appearance Scale: assessing body image among burn-injured patients. Psychological Assessment 1998; 10: 64-70.
Responsible Party: J. Peter Rubin, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01822301     History of Changes
Other Study ID Numbers: PRO12100585
First Submitted: March 19, 2013
First Posted: April 2, 2013
Results First Submitted: November 10, 2016
Results First Posted: May 12, 2017
Last Update Posted: July 11, 2017