Efficacy of Platelet-rich Plasma in Improving Postoperative Scarring After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
Cesarean section often leads to postoperative scarring, which can impact both physical and psychological well-being. Platelet-rich plasma (PRP), rich in growth factors, is used in regenerative medicine to promote healing and reduce inflammation.
详细描述
Background:
Cesarean section often leads to postoperative scarring, which can impact both physical and psychological well-being. Platelet-rich plasma (PRP), rich in growth factors, is used in regenerative medicine to promote healing and reduce inflammation.
Objective:
To evaluate the efficacy of intraoperative PRP in accelerating scar healing after cesarean section, using:
Six visual scar assessment scales (Manchester, POSAS, Vancouver, VAS, NRS, REEDA) Hematological parameters (hemoglobin, hematocrit, leukocytes, platelets)
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients, 18 to 45 years old. Scheduled for elective or emergency cesarean section at the participating center.
- •Singleton pregnancy (one fetus). Ability to provide written informed consent. Agreement to comply with the study protocol and follow-up visits at day 7 and day 40 postpartum.
排除标准
- •Known coagulation disorders (e.g., thrombocytopenia, hemophilia). Platelet count below 150,000/μL at the time of enrollment. Use of anticoagulant or antiplatelet therapy within 7 days before surgery. Active infection at the surgical site. History of autoimmune diseases affecting wound healing (e.g., lupus, scleroderma).
- •Known keloid formation tendency (optional: include if you want to exclude high-risk scarring profiles).
- •Multiple pregnancies (twins, triplets, etc.). Patients participating in another interventional clinical trial could interfere with outcomes.
- •Inability to follow up for the postoperative evaluations at 7 and 40 days. Refusal to consent or withdrawal of consent at any point
研究组 & 干预措施
Control: No Intervention Group
Patients undergo standard cesarean section with no PRP administration or placebo.
Experimental: PRP Group
Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure).
干预措施: Platelet-Rich Plasma (PRP) intraoperatively (Other)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS)
时间窗: up to 40 days
The Patient and Observer Scar Assessment Scale (POSAS) POSAS Score Overview: Scale range: Each item is scored from 1 to 10 Minimum total score: 6 (best possible scar) Maximum total score: 60 (worst possible scar) Higher scores indicate worse scar quality Lower scores indicate better scar quality (closer to normal skin)
次要结局
- Visual Analog Scale (VAS)(up to 40 days)
- Redness, Erythema, Edema, Ecchymosis, Discharge(up to 40 days)
研究者
Brezeanu Dragos
Principal Investigator
Saint Andrew Hospital Constanta