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临床试验/NCT06658444
NCT06658444招募中不适用

Effect of Onion Extract Nanoparticle Gel Phonophoresis on Postsurgical Scar of Cesarean Section

October 6 University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Modified Vancouver scar scale

研究概览

简要总结

Cesarean section is one of the most common abdominal operations performed on women. The cesarean section rate is rising rapidly and continuously in many parts of the world. The cesarean-section surgery leaves a scar that requires special care. A horizontal skin incision approximately 10-15 cm long is usually performed during the procedure. Apart from the skin, the following: subcutaneous tissue, fascia, peritoneum, and uterine muscle are cut leaving traces in the form of scars and accompanying ailments, on the one hand, such as pain, tenderness, and hypersensitivity to stimuli, and on the other, limitations, such as contractures or impairment of tissue mobility

详细描述

All this may directly influence the patient's quality of life. There is also a significant negative impact on the psychological and social aspects of life, caused by the appearance of an unesthetic scar. Improper wound healing affects the area Therefore, it can affect the aesthetic appearance of the abdomen and cause, among others, posture asymmetry, gait disturbance, and pain in the lumbar spine. A growing number of patients are dissatisfied with the appearance of their scars. The efficacy of many existing prophylactic and therapeutic strategies has been proven through extensive use, also data on several approaches have been contradictory regarding the efficacy and side effects. Topical therapies have their advantages; specifically, increased adherence, the localized delivery of the product, and the reduced impact of first-pass metabolism. Onion extract contains a range of phenolic anti-oxidant and anti-inflammatory compounds and was originally used for treating full and partial-thickness burns; however, more recently these have been trialed for treating hypertrophic and keloid scarring, and healing wounds. onion extract plays the main role in reducing scars by inhibiting fibroblast proliferation and collagen production. onion extract is also believed to have anti-inflammatory and antimicrobial effects. Some studies on the preventive and treatment effectiveness of onion extract on hypertrophic scars demonstrated its capability to improve scar appearance Ultrasound-based therapy has shown to be a viable option for abnormal scarring. It has been shown to reduce the growth of keloids or postoperative scars and to facilitate the penetration of anti-scarring drugs into the dermis ). Advantages of phonophoresis include noninvasiveness, good compliance, low cost, and minimal gastrointestinal side effects

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
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Their ages will be ≥18 years old. All women had given birth via elective abdominal transversal C-section for the first time.
  • All women suffering from Postsurgical Scar Of Cesarean-Section about 2-3 months post-surgery.
  • All women will provide an informed consent form agreeing to participate and publication of the study results

排除标准

  • Any pathological conditions or associated injuries affect the result of the study.
  • Skin disease. Cognitive and psychological impairment. Patients have implanted electronic devices, such as cardiac pacemakers, to prevent ultrasound interference.
  • Women with diabetes, cardiovascular problems, or a previous history of any disorder may alter sensation and delay the healing process which counteracts the study's goal.

结局指标

主要结局

Modified Vancouver scar scale

时间窗: 12 weeks

Assesses four characteristics of vascularity, pigmentation, pliability, and height The larger the The larger the total score, the worse the scar . Normal skin (zero score)

Tonometer

时间窗: 12 weeks

Tonometer The measurement area is placed directly under the tissue tonometer. A blunt piston is pressed into the tissue by the weight, and the resulting output reading is shown. The measurements are proportional to the tissue's pliability. All measurement procedures will be explained to each woman in both groups.

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

heba Haridy

lecturer of basic science department

October 6 University

研究点 (1)

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