Benha faculty of medicine hospital
Banhā, Qaluybia, Egypt
NCT Number: NCT07763275
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Banhā, Qaluybia, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criteria
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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.
Topical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection.
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.
Time frame: Baseline to 3months after treatment
Change in total POSAS score from baseline to 1 month after treatment, comparing the nanofat-treated site with the silicone-gel-only control site.
Time frame: 1 month and 3 months after treatment
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.
Time frame: Baseline, 1 month, and 3 months after treatment
Clinical and standardized photographic assessment of changes in the appearance and characteristics of the treated scars compared with baseline.
Time frame: From treatment through 3 months after treatment
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.
Benha University
Other
Evaluation of the Effect of Autologous Nanofat Injection in the Treatment of Atrophic Scars
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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