3-D Imaging Assessment of Scar Formation and Would Healing in Fat Grafted vs Non-Fat Grafted Facial Reconstruction Wound Sites
Scar Formation, Autologous Fat Grafting
About this trial
This is an interventional treatment trial for Scar Formation focused on measuring Scar, Fat Grafting, Adipose Grafting, 3-D imaging, Manchester Scar Scale
Eligibility 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
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Fat Grafted
Non-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.
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.