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

NCT06566300 | Recruiting

• 1 other identifier: Nanofat scar
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scars

Outcome Measures

Primary Outcomes (1)

• change in the scar by by the patient and observer scar assessment scale (POSAS).

  patient and observer scar assessment scale score will be uesd

  6 months after the proceedure

Study Arms (2)

injection of autologous nanofat grafting

EXPERIMENTAL

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

microneedling with autologous nanofat graft

EXPERIMENTAL

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

Interventions

injection of autologous nanofat grafting PROCEDURE

Injection of nanfat graft

injection of autologous nanofat grafting

microneedling with autologus nanofat graft PROCEDURE

delivery of nanofat graft with microneedling

microneedling with autologous nanofat graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. Patients with contractures, hypertrophic and keloid scars. 2. Patients with history of bleeding disorders or coagulopathy, or on anticoagulant therpy.
• \. Diabetes and other systemic diseases that may be complicated by the procedure.
• \. Pregnant and lactating females. 5. BMI less than 18.5 6. Patients with scars at the donor site

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Central Study Contacts

Dalia I Halwag, PhD, MD

CONTACT

0201224489473; daliahalwag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: To evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon request and as compatible by ethical considerations

Locations

EG (1)