Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nanofat in Post Burn Scars on the Face

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03352297
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Muhammad Mustehsan Bashir, King Edward Medical University

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

Condition or disease Intervention/treatment Phase
Burn Scar Biological: Unfiltered Nanofat Graft Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rejuvenation of Post Burn Scars on the Face With Unfiltered Nanofat Injection
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars


Intervention Details:
  • Biological: Unfiltered Nanofat Graft
    Nanofat created from microfat, skipping the filtration step. Intradermal and subdermal injections in post burn scars on the face.


Primary Outcome Measures :
  1. Rejuvenation of post burn scars on the face with unfiltered nanofat injection [ Time Frame: 1 year ]
    Pre and post-operative POSAS score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post burn scars on the face
  • Fitzpatrick skin types between 3 and 4

Exclusion Criteria:

  • Hypertrophic scars
  • Contractures
  • Keloids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352297


Sponsors and Collaborators
King Edward Medical University
Investigators
Layout table for investigator information
Principal Investigator: Saadia Jan, FRCS ed, FCPS King Edward Medical University Lahore

Publications of Results:
Goisis M, Stella E, Di Petrillo A, Rosset L. Nanofat Grafting Compared to Hyaluronic Acid and PRP Treatment of the Lower Lid and Tear Trough: Clinical Outcome. JSM Ophthalmology. 2015;3:1027

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Muhammad Mustehsan Bashir, Associate Professor, King Edward Medical University
ClinicalTrials.gov Identifier: NCT03352297    
Other Study ID Numbers: 249/PLS/MHL
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammad Mustehsan Bashir, King Edward Medical University:
Post burn scar face
Unfiltered nanofat
Adipose tissue growth factors
Adipose stem cells
POSAS
Image J
Face
Additional relevant MeSH terms:
Layout table for MeSH terms
Cicatrix
Burns
Wounds and Injuries
Fibrosis
Pathologic Processes