Postburn Scars; Posttraumatic ScarsNCT07763275
Autologous Nanofat for Treatment of Atrophic Scars
A study testing Autologous Nanofat Injection and Topical in people with Postburn Scars; Posttraumatic Scars and Atrophic Scar, run by Benha University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postburn Scars; Posttraumatic Scars, Atrophic Scar, Scar
- What is being tested?
- Autologous Nanofat Injection and Topical
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Autologous Nanofat Injection in the Treatment of Atrophic Scars
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.
Read the detailed description
This prospective, randomized, split-scar, within-participant controlled clinical study was conducted to evaluate the efficacy and safety of autologous nanofat injection in the treatment of atrophic postburn and posttraumatic scars.
Twenty participants with atrophic scars were included. Each participant had two comparable scar areas suitable for split-scar comparison. The two scar sites were randomly allocated to either the experimental intervention or the control intervention, allowing each participant to serve as his or her own control.
The experimental site received a single session of autologous nanofat injection followed by topical silicone gel application for 3 months. Autologous nanofat was prepared from the participant's own adipose tissue using the standardized study technique and injected into the assigned atrophic scar site. The control site received topical silicone gel alone for the same 3-month period.
Participants were evaluated at baseline, 1 month, and 3 months after treatment. Assessment included clinical history and physical examination, standardized digital photography, and evaluation using the Patient and Observer Scar Assessment Scale (POSAS). Patient satisfaction was assessed using a Likert satisfaction scale at follow-up visits.
Treatment-related adverse events and local reactions were recorded throughout the follow-up period, including pain, erythema, edema, bruising, infection, pigmentation changes, nodules, contour abnormalities, and other unexpected or clinically relevant events.
The primary objective was to determine whether the addition of a single session of autologous nanofat injection to topical silicone gel resulted in greater improvement in atrophic scar characteristics compared with topical silicone gel alone. The primary efficacy assessment was based on the change in POSAS score from baseline to 3 months.
Because of the split-scar design, comparisons between the nanofat-treated and control sites were performed within the same participant, thereby reducing the effect of interindividual variability in scar characteristics and healing response.
- Conditions
- Postburn Scars; Posttraumatic Scars, Atrophic Scar, Scar
- Being tested
- Autologous Nanofat Injection, Topical
- Keywords
- atrophic scar, fat, autologous
- Medical subject headings
- Cicatrix, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Nanofat InjectionProcedure or surgery
A single session of autologous nanofat injection was performed in the randomly assigned scar site. The nanofat was prepared from the participant's own adipose tissue using the study's standardized processing technique. Following the procedure, topical silicone gel was applied to the treated scar site for 3 months.
TopicalOther
Topical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection.
| Study group | Role | What they receive |
|---|---|---|
| Nanofat Injection + Silicone Gel | Experimental | A single session of autologous nanofat injection was performed in the randomly assigned scar site. The nanofat was prepared from the participant's own adipose tissue using the study's standardized processing technique. Following the procedure, topical silicone gel was applied to the treated scar site for 3 months. Receives: Procedure: Autologous Nanofat Injection |
| Topical Silicone Gel | Active comparator | Topical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection. Receives: Other: Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient and Observer Scar Assessment Scale (POSAS) Score
Change in the total POSAS score from baseline to 3 months after treatment, comparing the nanofat-treated scar site with the silicone-gel-only control site within the same participant.
Measured: Baseline to 3 months after treatment
Secondary outcomes (4)
Change in POSAS Score at 1 Month and 3months
Change in total POSAS score from baseline to 1 month after treatment, comparing the nanofat-treated site with the silicone-gel-only control site.
Measured: Baseline to 3months after treatment
Patient Satisfaction
Patient-reported satisfaction with the treated scar assessed using a Likert satisfaction scale, comparing the nanofat-treated site with the silicone-gel-only control site.
Measured: 1 month and 3 months after treatment
Clinical and Photographic Improvement
Clinical and standardized photographic assessment of changes in the appearance and characteristics of the treated scars compared with baseline.
Measured: Baseline, 1 month, and 3 months after treatment
Treatment-Related Adverse Events
Incidence and severity of treatment-related adverse events and local reactions, including pain, erythema, edema, bruising, infection, pigmentation changes, nodules, contour abnormalities, and other clinically relevant adverse events.
Measured: From treatment through 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Oct 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postburn Scars; Posttraumatic ScarsStudies of the same condition, open and under way.
- More trials run by Benha 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
- This was a randomized, split-scar, within-participant controlled study. Each participant had two comparable atrophic scar sites. The two sites were randomly allocated to either autologous nanofat injection followed by topical silicone gel or topical silicone gel alone. Each participant therefore served as his or her own control. Both treatment sites were assessed at baseline, 1 month, and 3 months using clinical examination, standardized photography, POSAS, patient satisfaction assessment, and adverse-event monitoring.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karem Taha ibrahim khalil, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763275
- Sponsor's protocol ID
- MS 9-3-2024
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available because of the small sample size and privacy/confidentiality considerations.
Publications
Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
PubMed 23783059van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PubMed 16079683Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
PubMed 15253184
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Autologous Nanofat Injection in the Treatment of Atrophic Scars
- ClinicalTrials.gov ID
- NCT07763275
- Acronym / sponsor ID
- MS 9-3-2024
- Conditions
- Postburn Scars; Posttraumatic Scars, Atrophic Scar, Scar
- Keywords
- atrophic scar, fat, autologous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 13 Aug 2026 (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.
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.
Detailed description
This prospective, randomized, split-scar, within-participant controlled clinical study was conducted to evaluate the efficacy and safety of autologous nanofat injection in the treatment of atrophic postburn and posttraumatic scars.
Twenty participants with atrophic scars were included. Each participant had two comparable scar areas suitable for split-scar comparison. The two scar sites were randomly allocated to either the experimental intervention or the control intervention, allowing each participant to serve as his or her own control.
The experimental site received a single session of autologous nanofat injection followed by topical silicone gel application for 3 months. Autologous nanofat was prepared from the participant's own adipose tissue using the standardized study technique and injected into the assigned atrophic scar site. The control site received topical silicone gel alone for the same 3-month period.
Participants were evaluated at baseline, 1 month, and 3 months after treatment. Assessment included clinical history and physical examination, standardized digital photography, and evaluation using the Patient and Observer Scar Assessment Scale (POSAS). Patient satisfaction was assessed using a Likert satisfaction scale at follow-up visits.
Treatment-related adverse events and local reactions were recorded throughout the follow-up period, including pain, erythema, edema, bruising, infection, pigmentation changes, nodules, contour abnormalities, and other unexpected or clinically relevant events.
The primary objective was to determine whether the addition of a single session of autologous nanofat injection to topical silicone gel resulted in greater improvement in atrophic scar characteristics compared with topical silicone gel alone. The primary efficacy assessment was based on the change in POSAS score from baseline to 3 months.
Because of the split-scar design, comparisons between the nanofat-treated and control sites were performed within the same participant, thereby reducing the effect of interindividual variability in scar characteristics and healing response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a randomized, split-scar, within-participant controlled study. Each participant had two comparable atrophic scar sites. The two sites were randomly allocated to either autologous nanofat injection followed by topical silicone gel or topical silicone gel alone. Each participant therefore served as his or her own control. Both treatment sites were assessed at baseline, 1 month, and 3 months using clinical examination, standardized photography, POSAS, patient satisfaction assessment, and adverse-event monitoring.
| Arm | Type | Receives |
|---|---|---|
| Nanofat Injection + Silicone Gel | Experimental | Procedure: Autologous Nanofat InjectionA single session of autologous nanofat injection was performed in the randomly assigned scar site. The nanofat was prepared from the participant's own adipose tissue using the study's standardized processing technique. Following the procedure, topical silicone gel was applied to the treated scar site for 3 months. |
| Topical Silicone Gel | Active comparator | Other: TopicalTopical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Autologous Nanofat InjectionA single session of autologous nanofat injection was performed in the randomly assigned scar site. The nanofat was prepared from the participant's own adipose tissue using the study's standardized processing technique. Following the procedure, topical silicone gel was applied to the treated scar site for 3 months. | Procedure or surgery | Nanofat Injection + Silicone Gel |
| TopicalTopical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection. | Other | Topical Silicone Gel |
Primary outcome
Change in Patient and Observer Scar Assessment Scale (POSAS) Score
Time frame: Baseline to 3 months after treatment
Change in the total POSAS score from baseline to 3 months after treatment, comparing the nanofat-treated scar site with the silicone-gel-only control site within the same participant.
4 secondary outcomes
Change in POSAS Score at 1 Month and 3months
Time frame: Baseline to 3months after treatment
Patient Satisfaction
Time frame: 1 month and 3 months after treatment
Clinical and Photographic Improvement
Time frame: Baseline, 1 month, and 3 months after treatment
Treatment-Related Adverse Events
Time frame: From treatment through 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Results publication: PubMed 23783059Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.
- Results publication: PubMed 16079683van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
- Results publication: PubMed 15253184Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Individual participant dataSharing planned: No. Individual participant data will not be made available because of the small sample size and privacy/confidentiality considerations.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Nanofat Injection and Topical in people with Postburn Scars; Posttraumatic Scars and Atrophic Scar, run by Benha 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 13 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient and Observer Scar Assessment Scale (POSAS) Score (time frame: Baseline to 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07763275, which also lists 3 linked publications.
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 13 Aug 2026.