Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 主要终点
- Wound healing time and healing rate
研究概览
简要总结
Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Wound size <10X10cm2, the wound base only involves subcutaneous and muscle tissue；
- •Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；
- •There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered
- •Men or women older than 17 years old and younger than 75 years old;
- •Psychologically stable, able to complete the test process.
排除标准
- •Wound size>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity;
- •Surgical incision with purulent infection, local purulent secretions can be seen;
- •Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;
- •Patients with diabetes;
- •Glucocorticoid users;
- •Patients with immune dermatosis;
- •Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion;
- •Psycho-psychological disorders and poor compliance.
研究组 & 干预措施
control group
No intervention
experimental group
The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2)
干预措施: The pleiotropic factor derived from mesenchymal stem cells (Biological)
结局指标
主要结局
Wound healing time and healing rate
时间窗: 1 month
Judgment criteria for incision recovery (4 weeks after treatment): Cure: the patient's incision is completely or basically healed, and the surrounding skin returns to normal; markedly effective: the patient's incision is recovered\> 1/2, and the surrounding skin returns to normal; effective: the patient's incision is recovered \<1 /2, and the surrounding skin returned to normal; invalid: the patient's incision had no obvious changes, and the surrounding skin color had no obvious improvement.
次要结局
未报告次要终点
研究者
Xiaobing Fu
Professor
Chinese PLA General Hospital