Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.
详细描述
Cesarean deliveries are among the most frequently performed surgical procedures for women worldwide, with their prevalence increasing globally, especially in developing nations like Egypt.
A scar is a natural outcome of the healing process following a wound. Complaints associated with scars can lead to both physical discomfort and psychological challenges. Enhanced healing of CS scars could lead to better postoperative outcomes, reducing complications such as infection, pain, and restricted mobility. These aspects of recovery are often neglected, as noted by.
This study will be the first to specifically examine the effects of Bioptron light therapy on CS scar formation. While previous research has shown the benefits of this therapy on scars from various operations, none have focused on CS scars. By investigating this innovative, non-invasive treatment approach, the study aims to fill a critical gap in existing research and offer valuable insights into managing and improving postoperative recovery for CS patients.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The participants' ages will be ranged from 20-30 years old.
- •Their body mass index (BMI) will not exceed 30 kg/m
- •They will be primipara and having abdominal scar after CS.
- •The scar age will be extended from 6 weeks to 6 months.
- •All women will be medically stable when attending the study.
排除标准
- •Pregnant women or women planning to become pregnant during the study period.
- •Women having diabetes mellitus.
- •Women taking immunosuppressant drugs.
研究组 & 干预措施
Silicone-based products group
The participants will be treated with cosmetic creams such as Silicone-based products, (silicone gels for 1 month).
干预措施: Silicon based products (silicon gel) (Other)
Bioptron and Silicone-based products group
The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, in addition to the cosmetic creams (Silicone-based products; silicone gels) for one month.
干预措施: Silicon based products (silicon gel) (Other)
Bioptron and Silicone-based products group
The participants will be treated by polarized light therapy (Bioptron) for 15 minutes, 3 sessions per week, in addition to the cosmetic creams (Silicone-based products; silicone gels) for one month.
干预措施: Bioptron (polarized light therapy) (Device)
结局指标
主要结局
The Patient and Observer Scar Assessment Scale (POSAS)
时间窗: 4 weeks
It is a comprehensive tool designed to evaluate scar quality from both the patient's and the observer's perspectives before and after treatment for all participants in both groups. This scale includes two separate assessments: one completed by the patient and the other by the healthcare professional observing the scar. Each part of the scale assesses different aspects of the scar, providing a holistic view of its impact and severity. Each scale assesses six scar characteristics: the observer evaluates vascularization, pigmentation, thickness, surface roughness, pliability, and surface area, while the patient rates pain, pruritus, color, thickness, relief, and pliability. All items are scored on a 10-point scale, with 1 indicating 'normal skin' and 10 representing the 'worst imaginable scar.' Higher total scores indicate poorer scar quality
Vancouver scar scale
时间窗: 4 weeks
The Vancouver Scar Scale (VSS) is a widely used tool for assessing the quality and severity of scars before and after treatment for all participants in both groups. The VSS helps clinicians objectively measure the effectiveness of treatments and track changes in scar characteristics over time The VSS rated the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing the worst scar imaginable).
次要结局
- Adheremeter(4 weeks)
研究者
Ghadeer Abdelazzim Mostafa
Principal investigator
Cairo University