ScarsNCT06566300
Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars
A study testing injection of autologous nanofat grafting and microneedling with autologus nanofat graft in people with Scars, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scars
- What is being tested?
- injection of autologous nanofat grafting and microneedling with autologus nanofat graft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria
Dalia I Halwag, MD, PhD, 0201224489473, daliahalwag@gmail.com
About this study
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
- Being tested
- injection of autologous nanofat grafting, microneedling with autologus nanofat graft
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of autologous nanofat graftingProcedure or surgery
Injection of nanfat graft
microneedling with autologus nanofat graftProcedure or surgery
delivery of nanofat graft with microneedling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: microneedling with autologus nanofat graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the scar by by the patient and observer scar assessment scale (POSAS).
patient and observer scar assessment scale score will be uesd
Measured: 6 months after the proceedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Nov 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ibrahim Halwag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566300
- Sponsor's protocol ID
- Nanofat scar
- Status last verified
- Nov 2024
- First submitted
- 20 Aug 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request and as compatible by ethical considerations
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars
- ClinicalTrials.gov ID
- NCT06566300
- Acronym / sponsor ID
- Nanofat scar
- Conditions
- Scars
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.
| Arm | Type | Receives |
|---|---|---|
| injection of autologous nanofat grafting | Experimental | Procedure: injection of autologous nanofat graftingTwo 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. |
| microneedling with autologous nanofat graft | Experimental | Procedure: microneedling with autologus nanofat graftTwo 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of autologous nanofat graftingInjection of nanfat graft | Procedure or surgery | injection of autologous nanofat grafting |
| microneedling with autologus nanofat graftdelivery of nanofat graft with microneedling | Procedure or surgery | microneedling with autologous nanofat graft |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Yes. Upon request and as compatible by ethical considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of autologous nanofat grafting and microneedling with autologus nanofat graft in people with Scars, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia I Halwag, PhD, MD (0201224489473, daliahalwag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the scar by by the patient and observer scar assessment scale (POSAS). (time frame: 6 months after the proceedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.