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临床试验/NCT06664268
NCT06664268尚未招募早期 1 期

Clinical and Ultrasound Assessment of Efficacy of Plasma Rich Fibrin (PRF) Injection and Fractional CO2 Laser in Treatment of Postburn Hypertrophic Scars: a Randomized Controlled Clinical Trial

Assiut University0 个研究点目标入组 30 人开始时间: 2024年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
30
主要终点
Clinical Assessment

研究概览

简要总结

Recent advancements in scar management include the use of Plasma Rich Fibrin (PRF) injections and fractional CO2 laser treatments. Both modalities are considered innovative approaches that offer promising outcomes in scar revision .

Plasma Rich Fibrin (PRF) is a newer modality in regenerative medicine derived from the patient's own blood. Unlike platelet-rich plasma (PRP), PRF does not use anticoagulants during processing, leading to a natural fibrin matrix that supports prolonged release of growth factors and cytokines . This matrix has been shown to enhance wound healing and improve scar texture and appearance. Studies have demonstrated PRF's efficacy in treating various skin conditions, including acne scars and general skin rejuvenation, suggesting potential benefits for postburn scar management .

Fractional CO2 laser therapy is a well-established technique for scar treatment, including postburn scars. This technology utilizes laser energy to create microthermal zones in the skin, which stimulates collagen production and skin remodeling while minimizing damage to surrounding tissues . Clinical trials have validated the effectiveness of fractional CO2 lasers in reducing scar thickness and improving skin texture, making it a popular choice for scar revision .

详细描述

Postburn scars often result in significant functional and aesthetic challenges for plastic surgeons. These scars can cause physical limitations, psychological distress, and a decrease in quality of life. Traditional treatments, including topical therapies, silicone gel sheets, and surgical interventions, frequently fall short in providing optimal results, particularly for extensive or complex scars .

Recent advancements in scar management include the use of Plasma Rich Fibrin (PRF) injections and fractional CO2 laser treatments. Both modalities are considered innovative approaches that offer promising outcomes in scar revision .

Plasma Rich Fibrin (PRF) is a newer modality in regenerative medicine derived from the patient's own blood. Unlike platelet-rich plasma (PRP), PRF does not use anticoagulants during processing, leading to a natural fibrin matrix that supports prolonged release of growth factors and cytokines . This matrix has been shown to enhance wound healing and improve scar texture and appearance. Studies have demonstrated PRF's efficacy in treating various skin conditions, including acne scars and general skin rejuvenation, suggesting potential benefits for postburn scar management .

Fractional CO2 laser therapy is a well-established technique for scar treatment, including postburn scars. This technology utilizes laser energy to create microthermal zones in the skin, which stimulates collagen production and skin remodeling while minimizing damage to surrounding tissues . Clinical trials have validated the effectiveness of fractional CO2 lasers in reducing scar thickness and improving skin texture, making it a popular choice for scar revision .

Despite the individual benefits of PRF and fractional CO2 laser treatments, there is a lack of direct comparative studies assessing their relative efficacy in postburn scar management. Comparative research is essential to determine which treatment provides superior outcomes and to guide clinical decision-making .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 18 to 60 years
  • Mature post burn scars (more than 6 months).
  • Scar area does not exceed 5% of body surface area (TBSA).

排除标准

  • Immature scars (less than 6 months).
  • Large scar area (more than 5%of body surface area (TBSA).
  • Previous scar treatment with other modalities.
  • Keloid scars.

研究组 & 干预措施

Group A

Active Comparator

fractional CO2 laser alone

干预措施: Fractional CO2 laser assisted PDT (Device)

Group B

Active Comparator

PRF Injection and fractional CO2 laser

干预措施: Plasma rich in growth factors (PRGF-Endoret) (Biological)

Group B

Active Comparator

PRF Injection and fractional CO2 laser

干预措施: Fractional CO2 laser assisted PDT (Device)

结局指标

主要结局

Clinical Assessment

时间窗: 6 months

1. Clinical Assessment: By Vancouver Scar Scale (VSS) which consists of four items: 1. Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 2. Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 3. Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 4. Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3 It has a score ranging from 0-13 , The VSS set a precedent for systematic scar assessment by collecting subjective assessments and using a semiquantitative approach. 0 (best) - 13 (worst)

Ultrasound Assessment

时间窗: 6 months

Ultrasound Assessment: to detect changes in hypertrophic scar thickness before, during, and after treatment By Measurement of * scar thickness in millimeters

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Emad Ahmed

plastic & reconstructive surgery Resident

Assiut University

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