Nanofat in Post Burn Scars on the Face
Primary Purpose
Burn Scar
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Unfiltered Nanofat Graft
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar focused on measuring Post burn scar face, Unfiltered nanofat, Adipose tissue growth factors, Adipose stem cells, POSAS, Image J, Face
Eligibility Criteria
Inclusion Criteria:
- Post burn scars on the face
- Fitzpatrick skin types between 3 and 4
Exclusion Criteria:
- Hypertrophic scars
- Contractures
- Keloids
Sites / Locations
Outcomes
Primary Outcome Measures
Rejuvenation of post burn scars on the face with unfiltered nanofat injection
Pre and post-operative POSAS score
Secondary Outcome Measures
Full Information
NCT ID
NCT03352297
First Posted
November 15, 2017
Last Updated
November 22, 2017
Sponsor
King Edward Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03352297
Brief Title
Nanofat in Post Burn Scars on the Face
Official Title
Rejuvenation of Post Burn Scars on the Face With Unfiltered Nanofat Injection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Quasi-Experimental Study: Unfiltered Nanofat Injected into Postburn Facial Scars Number of Patients: 48 Outcome Assessed on POSAS And with Imaje J Scanning Preop And Postop Statistical Comparison of Scar Done
Detailed Description
Objective: To compare the quality of post burn facial scars before and after injection of unfiltered nanofat.
Place and Duration of Study: Plastic Surgery Department, Mayo Hospital, Lahore, from January 2016 to December 2016.
Methodology: 48 patients with post burn facial scars were included, age range 4 to 32 years with Fitzpatrick skin types between 3 and 4. Patients with hypertrophic scars, contractures or keloids were excluded. Scars were assessed by a senior plastic surgeon and the patient on the POSAS. Fat was harvested from the abdomen and/or thighs with a 3 mm multi-port liposuction cannula (containing several sharp side holes of 1 mm) using Coleman's technique, emulsified, and transferred into 1 ml Leur lock syringes for injection into the subdermal or intradermal plane. Final follow up was scheduled at 6 months and scar was rated by the patient and the same surgeon on the POSAS. Pre and post op scar scores were compared and p-values calculated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
Keywords
Post burn scar face, Unfiltered nanofat, Adipose tissue growth factors, Adipose stem cells, POSAS, Image J, Face
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Unfiltered Nanofat Graft
Intervention Description
Nanofat created from microfat, skipping the filtration step. Intradermal and subdermal injections in post burn scars on the face.
Primary Outcome Measure Information:
Title
Rejuvenation of post burn scars on the face with unfiltered nanofat injection
Description
Pre and post-operative POSAS score
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post burn scars on the face
Fitzpatrick skin types between 3 and 4
Exclusion Criteria:
Hypertrophic scars
Contractures
Keloids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saadia Jan, FRCS ed, FCPS
Organizational Affiliation
King Edward Medical University Lahore
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Nanofat in Post Burn Scars on the Face
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