Evaluation of the Effect of Autologous Nanofat Injection in the Treatment of Atrophic Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Patient and Observer Scar Assessment Scale (POSAS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
研究组 & 干预措施
Nanofat Injection + Silicone Gel
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.
干预措施: Autologous Nanofat Injection (Procedure)
Topical Silicone Gel
Topical silicone gel was applied to the randomly assigned control scar site for 3 months without nanofat injection.
干预措施: Topical (Other)
结局指标
主要结局
Change in Patient and Observer Scar Assessment Scale (POSAS) Score
时间窗: 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.
次要结局
- 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)
研究者
karem Taha ibrahim khalil
Assistant professor of Dermatology,Venereology and Andrology
Benha University