Autologous Nanofat for Treatment of Atrophic Scars (NCT07763275) | Clinical Trial Compass
CompletedNot Applicable
Autologous Nanofat for Treatment of Atrophic Scars
Egypt20 participantsStarted 2024-10-01
Plain-language summary
A prospective, randomized, split-scar, within-participant controlled clinical study evaluating the efficacy and safety of a single session of autologous nanofat injection followed by topical silicone gel in the treatment of atrophic postburn or posttraumatic scars. Each participant will have two comparable scar areas/sites. One site will receive autologous nanofat injection followed by topical silicone gel, while the contralateral/comparable control site will receive topical silicone gel alone. Participants will be followed for 3 months, with assessments at baseline, 1 month, and 3 months.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older.
* Presence of clinically diagnosed atrophic postburn or posttraumatic scars.
* Scars were stable and mature at the time of enrollment.
* Presence of two comparable scar areas suitable for the split-scar study design.
* Scar sites were suitable for standardized clinical and photographic assessment.
* Participants were willing to undergo a single session of autologous nanofat injection.
* Participants were able to comply with the study visits and 3-month follow-up.
* Written informed consent was obtained before participation.
Exclusion Criteria
* Hypertrophic scars or keloids.
* Active infection, inflammation, ulceration, or dermatitis at the selected scar sites.
* Previous procedural treatment of the selected scar sites that could affect study assessment.
* Significant uncontrolled systemic disease that could interfere with wound healing or treatment.
* Bleeding disorders or other contraindications to the fat-harvesting or injection procedure.
* Pregnancy or breastfeeding.
* Known allergy or intolerance to the topical silicone gel used in the study.
* Inability to provide informed consent or comply with study follow-up.
* Any medical condition considered by the investigator to pose an unacceptable risk or interfere with study evaluation.
Exclusion Criteria:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient and Observer Scar Assessment Scale (POSAS) Score