Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars

November 2, 2024 updated by: Dalia Ibrahim Halwag, Alexandria University
This study aims to evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Alexandria University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Males and females between 18-60 years old. 2. Post-burn or traumatic atrophic scar > 6 months duration (16). 3. Patients not receiving any treatments for the scar within the past 3 months.

Exclusion Criteria:

  • 1. Patients with contractures, hypertrophic and keloid scars. 2. Patients with history of bleeding disorders or coagulopathy, or on anticoagulant therpy.

    3. Diabetes and other systemic diseases that may be complicated by the procedure.

    4. Pregnant and lactating females. 5. BMI less than 18.5 6. Patients with scars at the donor site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: injection of autologous nanofat grafting
Two separate scars with similar properties or splitting of one large post-burn atrophic scar. One (part of the) scar will be treated by injection of autologous nanofat grafting and the other (part of the) scar will be treated by microneedling with autologous nanofat graft.
Procedure: injection of autologous nanofat grafting
Injection of nanfat graft
Experimental: microneedling with autologous nanofat graft
Two separate scars with similar properties or splitting of one large post-burn atrophic scar. One (part of the) scar will be treated by injection of autologous nanofat grafting and the other (part of the) scar will be treated by microneedling with autologous nanofat graft.
Procedure: microneedling with autologus nanofat graft
delivery of nanofat graft with microneedling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in the scar by by the patient and observer scar assessment scale (POSAS).
Time Frame: 6 months after the proceedure
patient and observer scar assessment scale score will be uesd
6 months after the proceedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nanofat scar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon request and as compatible by ethical considerations

IPD Sharing Time Frame

Upon request and as compatible by ethical considerations

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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