Nanofat in Post Burn Scars on the Face

Sponsor
King Edward Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03352297
Collaborator
(none)
48
12

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Unfiltered Nanofat Graft
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
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 :
Jan 1, 2016
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Dec 31, 2016

Outcome Measures

Primary Outcome Measures

  1. Rejuvenation of post burn scars on the face with unfiltered nanofat injection [1 year]

    Pre and post-operative POSAS score

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Post burn scars on the face

  • Fitzpatrick skin types between 3 and 4

Exclusion Criteria:
  • Hypertrophic scars

  • Contractures

  • Keloids

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • King Edward Medical University

Investigators

  • Principal Investigator: Saadia Jan, FRCS ed, FCPS, King Edward Medical University Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Muhammad Mustehsan Bashir, Associate Professor, King Edward Medical University
ClinicalTrials.gov Identifier:
NCT03352297
Other Study ID Numbers:
  • 249/PLS/MHL
First Posted:
Nov 24, 2017
Last Update Posted:
Nov 24, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Muhammad Mustehsan Bashir, Associate Professor, King Edward Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2017