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

NCT ID: NCT06566300

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Scars

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

To evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

injection of autologous nanofat grafting

Intervention Type PROCEDURE

Injection of nanfat graft

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.

Group Type EXPERIMENTAL

microneedling with autologus nanofat graft

Intervention Type PROCEDURE

delivery of nanofat graft with microneedling

Interventions

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injection of autologous nanofat grafting

Injection of nanfat graft

Intervention Type PROCEDURE

microneedling with autologus nanofat graft

delivery of nanofat graft with microneedling

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Dalia Ibrahim Halwag

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dalia I Halwag, PhD, MD

Role: CONTACT

0201224489473

Facility Contacts

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Dalia I Halwag, MD, PhD

Role: primary

0201224489473

Other Identifiers

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Nanofat scar

Identifier Type: -

Identifier Source: org_study_id

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