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临床试验/NCT04557514
NCT04557514Unknown不适用

Comparative Study Between Fat Injection And Platelet Rich Plasma IN Post Burn Facial Scar Clinical And Histopathological Assessment

Assiut University0 个研究点目标入组 60 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
主要终点
vancouver scale

研究概览

简要总结

Best method in management of facial burn scar

详细描述

The stages of wound healing:proceed in an organized way and follow four processes: hemostasis, inflammation, proliferation and maturation. Although the stages of wound healing are linear, wounds can progress backward or forward depending on internal and external patient conditions. The four stages of wound healing are:Hemostasis Phase Hemostasis is the process of the wound being closed by clotting. Hemostasis starts when blood leaks out of the body. Inflammatory Phase Inflammation is the second stage of wound healing and begins right after the injury when the injured blood vessels leak transudate (made of water, salt, and protein) causing localized swelling. Proliferative Phase The proliferative phase of wound healing is when the wound is rebuilt with new tissue made up of collagen and extracellular matrix. Maturation Phase Also called the remodeling stage of wound healing, the maturation phase is when collagen is remodeled from type III to type I and the wound fully closes.

Fat Injection In Facial burn scar:The effects of the lipofilling can be seen starting from 3 weeks after the procedure, in terms of better scar color, pliability, thickness, relief, itching, pain, scar vascularization and pigmentation. Indeed, autologous fat grafting makes the skin softer, more flexible and extensible; besides, the color seems similar to the surrounding unharmed skin.

Platelet Rich Plasma In Facial burn scar: Impaired wound-healing and a long treatment course in severe burns as well as secondary complications originating from uncovered wounds motivate research to accelerate the wound-healing process and speed up re-epithelialization in burn patients.

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
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients With Post Burn Facial Scar
  • •Age: 15 _60 Yrs Old
  • •Mature Burn Scar (After 3 Months)

排除标准

  • •Patients Less Than 15 Yrs Old
  • •Patients More Than 60 Yrs Old
  • •Patients With Comorbidies (Hypertension-Diabetes-Thromboembolic Diseases-Immunocomprimized Patients)
  • •Patients With Burn Scar In Any Site Of Body Other Than Face

研究组 & 干预措施

platelet rich plasma injection in post burn facial scar

Active Comparator

prp in subgroup allocation 1:1 Obtain WB by venipuncture in acid citrate dextrose (ACD) tubes

Do not chill the blood at any time before or during platelet separation.

Centrifuge the blood using a 'soft' spin.

Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant).

Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate.

The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed.

Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.

干预措施: platelet rich plasma injection in post burn facial scar (Procedure)

platelet rich plasma injection in post burn facial scar

Active Comparator

prp in subgroup allocation 1:1 Obtain WB by venipuncture in acid citrate dextrose (ACD) tubes

Do not chill the blood at any time before or during platelet separation.

Centrifuge the blood using a 'soft' spin.

Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant).

Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate.

The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed.

Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.

干预措施: fat injection in post burn facial scar (Procedure)

fat injection in post burn facial scar

Active Comparator

After aspiration of the fatty tissue, it is important that nonviable components of the aspirate, such as oil, blood, and local anesthetics are removed and, at the same time, the quality, integrity, and viability of the adipocytes and the inherent mesenchymal stem cells in the aspirate be maintained. Processing techniques are sedimentation , filtering and washing There is no consensus as to the optimal method of fat graft preparation.

干预措施: platelet rich plasma injection in post burn facial scar (Procedure)

fat injection in post burn facial scar

Active Comparator

After aspiration of the fatty tissue, it is important that nonviable components of the aspirate, such as oil, blood, and local anesthetics are removed and, at the same time, the quality, integrity, and viability of the adipocytes and the inherent mesenchymal stem cells in the aspirate be maintained. Processing techniques are sedimentation , filtering and washing There is no consensus as to the optimal method of fat graft preparation.

干预措施: fat injection in post burn facial scar (Procedure)

结局指标

主要结局

vancouver scale

时间窗: 3 months

Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3

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

Abdelrahman Mostafa Shehata Mohammed

official investigator

Assiut University

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