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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
King Edward Medical University
About
Eligibility
Locations
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 15, 2017
    Last Updated
    November 22, 2017
    Sponsor
    King Edward Medical University
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    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
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    Nanofat in Post Burn Scars on the Face

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