Atrophic Scar, Postburn Scars; Posttraumatic Scars, Scar
Conditions
Keywords
atrophic scar, fat, autologous
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.
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.
Interventions
PROCEDUREAutologous Nanofat Injection
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.
OTHERTopical
Topical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection.
Sponsors
Benha University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient and Observer Scar Assessment Scale (POSAS) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in POSAS Score at 1 Month and 3months | 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. |
| Patient Satisfaction | 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. |
| Clinical and Photographic Improvement | 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. |
| Treatment-Related Adverse Events | 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. |
Countries
Egypt
Outcome results
None listed