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3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites

This study is currently recruiting participants.
Verified November 2012 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01750424
First received: December 12, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

The purpose of this study is to assess scar-formation and wound healing following the use of autologous fat grafting in facial reconstruction patients. Patients who have undergone facial reconstruction in the last 3 months will be randomized into two groups, one receiving fat grafting and one not receiving any intervention. These patients will continue to follow-up in our clinic for one year, with 3-D images taken at each follow-up visit to assess scar formation and wound healing. Assessment of the scar will be undertaken by both healthcare personnel as well as general lay public. We hypothesize that patients undergoing fat grafting to the wound site will achieve a more aesthetically appealing result, with less scarring and improved wound healing as judged by both the general public and healthcare professionals.


Condition Intervention Phase
Scar Formation
Autologous Fat Grafting
 Procedure: Autologous Fat Grafting
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale [ Time Frame: 3 months post-fat grafting ] [ Designated as safety issue: No ]
    An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.

  • Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale [ Time Frame: 6 months post-fat grafting ] [ Designated as safety issue: No ]
    An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.

  • Color, Vascularity, Distortion, Contour, and Appearance of Scar through use of Manchester Scar Scale [ Time Frame: 12 months post-fat grafting ] [ Designated as safety issue: No ]
    An independent group of observers/evaluators, consisting of medical students and other non-faculty medical personnel as well as general lay observers, will be asked to view the 3-D images from each time point, evaluate the aesthetic outcome, and grade the scars presented in each case. Scales used will be the Manchester Scar Scale, which has been used previously for photographic scar assessment, as well as a more lay-person's version of the Manchester Scar scale created for the use of an average observer. These forms assess the color, hypertrophy, vascularity, etc of the scar as compared to surrounding skin. The data collected will be analyzed using appropriate statistical software and/or calculations.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fat Grafted
The experimental arm of the study will be composed of 15 patients who undergo autologous fat grafting into the site of the facial reconstructive scar at 3 months post-operatively. A small amount of fat will be removed near the umbilicus through a cannula using local anesthetic and a small, 2-3mm incision just barely large enough for the cannula to pass. That fat will be injected directly under the scar site in those patients using a similar cannula, local anesthetic, and small, 2-3mm incision. No sutures will be required at either the donor or injection site. Patients will subsequently return to clinic for 3-D photographic assessment at 3, 6 and 12 months post-fat grafting. The images generated at each session will be provided to a group of assessors for evaluation. They will either use the Manchester Scar Scale or the modified Manchester Scar Scale depending on whether they are within the health care profession.
 Procedure: Autologous Fat Grafting
Other Names:
  • Fat Grafting
  • Adipose Grafting
Placebo Comparator: Non-fat grafted
The control arm will be composed of 15 patients who undergo no intervention. These patients will be identified at 3 months post-operatively from their facial reconstruction. They will undergo no fat-grafting but will be followed up with the same frequency as the experimental group, at 3 months, 6 months, and 12 months after their initial 3 month post-surgical follow-up. 3-D images will be taken at each appointment and will be distributed to all assessors. Assessors will use either the Manchester Scar Scale or a modified Manchester Scar Scale to evaluate the appearance of the scar at each time point.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy Subjects
  • Facial reconstruction surgery in the last 3 months

Exclusion Criteria:

  • Age less than 18 years
  • Patients undergoing skin grafting
  • Patients undergoing secondary intent closure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750424

Contacts
Contact: Derek Steinbacher, MD, DMD 203-785-2571 derek.steinbacher@yale.edu
Contact: Mikell Yuhasz, BA 330-519-1985 mikell.yuhasz@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Mikell Yuhasz, BA     330-519-1985     mikell.yuhasz@yale.edu    
Sub-Investigator: Mikell Yuhasz, BA            
Principal Investigator: Derek Steinbacher, MD, DMD            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Derek Steinbacher, MD, DMD Yale University
  More Information

Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01750424     History of Changes
Other Study ID Numbers: HIC-1209010842
Study First Received: December 12, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Scar
Fat Grafting
Adipose Grafting
3-D imaging
Manchester Scar Scale

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013