A Prospective Cohort Study Evaluating the Efficacy of a Double-layer Artificial Dermal Repair Material Combined With Growth Factors for Exposed Tendon Wounds
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Wound closure evaluation
研究概览
简要总结
Compared with the combination of double-layer artificial dermal repair materials combined with growth factors, and the treatment methods using double-layer artificial dermal repair materials, the time and effect of the two treatment regimens on the function and appearance of wound repair with exposed tendon were different, as well as the medical costs.
详细描述
This study used a prospective cohort study to select all patients who met the inclusion criteria in six hospitals within six months after the start of the trial, including no less than 55 patients receiving artificial dermis combined with growth factor and no less than 110 patients receiving simple artificial dermal treatment, and the cumulative number of patients was not less than 110 patients, to compare the time and effect of the two treatment options on the functional and cosmetic restoration of upper limb wound repair with exposed tendons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elbow joint to fingertip area, soft tissue defect accompanied by tendon exposed fresh wound, tendon exposed wound area of 2~20cm2, wound area 5-600cm2, need to transplant autologous skin;
- •Incomplete aponeurosis;
- •Voluntarily sign the informed consent form. For persons with no or limited capacity for civil conduct, obtain the consent of their guardians and sign an informed consent form.
排除标准
- •Wound infection or suspected osteomyelitis;
- •Chronic wounds;
- •More than 2/3 of the exposed tendons are suspended on the wound surface;
- •Those with serious primary diseases such as cardiovascular and cerebrovascular, liver and kidney and hematopoietic system, which cannot be treated by surgery;
- •Those who are allergic to collagen and chondroitin sulfate;
- •Other persons that the investigator deems unsuitable.
结局指标
主要结局
Wound closure evaluation
时间窗: 7 days after the patient implanted the autologous blade thick skin tablet
One week after transplantation of the autologous epidermis, the survival rate of skin grafting on the exposed tendon wound is localized.
Functional evaluation
时间窗: 6 months after surgery
Range of motion
Appearance evaluation
时间窗: 6 months after surgery
VSS（Vancouver scar scale） score of the supply area.About scars, color 0\~3 points; Thickness 0\~4 minutes; Vascular distribution 0\~3 points; Softness: 0\~5 points. All the points are added together, the smaller the better.
次要结局
未报告次要终点
研究者
Wang xingang
Deputy Director
Second Affiliated Hospital, School of Medicine, Zhejiang University