Autologous Nanofat for Treatment of Atrophic Scars

NCT07763275 | Completed

• 1 other identifier: MS 9-3-2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postburn Scars; Posttraumatic Scars; Atrophic Scar; Scar

Keywords

atrophic scar; fat; autologous

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 3 months after treatment

Secondary Outcomes (4)

• Change in POSAS Score at 1 Month and 3months

  Baseline to 3months after treatment

• Patient Satisfaction

  1 month and 3 months after treatment

• Clinical and Photographic Improvement

  Baseline, 1 month, and 3 months after treatment

• Treatment-Related Adverse Events

  From treatment through 3 months after treatment

Study Arms (2)

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.

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.

Other: Topical

Interventions

Autologous Nanofat Injection PROCEDURE

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.

Nanofat Injection + Silicone Gel

Topical OTHER

Topical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection.

Topical Silicone Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha faculty of medicine hospital

Banhā, Qaluybia, Egypt

Location

Related Publications (3)

• 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.

  PMID: 23783059 RESULT

• van 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.

  PMID: 16079683 RESULT

• Draaijers 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.

  PMID: 15253184 RESULT

MeSH Terms

Conditions

Cicatrix; Platelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was open-label to the participants and treating investigator; however, the independent assessor responsible for POSAS and standardized photographic assessment was blinded to the treatment allocation of each scar site.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Dermatology,Venereology and Andrology

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)