Clinical Randomized Controlled Trials on Negative Pressure Wound Therapy for Skin Grafts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 主要终点
- healing rate (the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements)
研究概览
简要总结
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, poorly healing areas, reduce the success rate of skin-grafting with traditional bolster dressings, increasing morbidity, pain. Negative pressure wound therapy has been advocated as a potential solution to some of these issues. To further test the healing rate and safety of this new method, the investigators propose a prospective randomized controlled trial to compare this method with traditional bolster dressings application in skin-grafting.
详细描述
The repairing of various wounds is always a great challenge in burn surgery and plastic surgery. Skin-grafting is the main therapy. Bolster dressings are traditionally applied to secure the graft to the wound bed, however, there is some evidence to show that irregularly contoured recipient sites, exuding wounds, poorly healing areas, and the presence of shear stress significantly reduce the success rate of skin-grafting with traditional bolster dressings, increasing morbidity, pain, hospital stay, and cost. Negative pressure wound therapy (NPWT) has been advocated as a potential solution to some of these issues. the application of NPWT to skin-grafting may promote blood flow and microcirculation to the graft bed, reduction of edema, exudates, and hematomas, and result in significant qualitative improvement in split skin graft take. To further test the healing rate and safety of this new method, the investigators propose a prospective randomized controlled trial to compare this method with traditional bolster dressings application in skin-grafting.
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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who need to skin graft to repair the wound
- •Subjects signed the informed consent in the day of the age of not more than 85 years old (for minors, legal guardian should be signed)
- •Stable vital signs, regular examination showed that subjects could tolerate surgery
- •Subjects' mental state are good, could follow the doctor's advice, visit on a regular basis
- •Understanding and willing to participate in this clinical trial and signed informed consent
- •All women subjects must agree to take effective contraceptive measures in the six months study period, and without pregnancy before participate in the treatment
- •No other serious diseases conflicts with the trail
排除标准
- •Allergic constitution of negative pressure dressing
- •Severe uncontrolled disease or acute systemic infections and complication with other serious heart, lung disease, encephalopathy and other organs or have a rapid progress or terminal disease
- •Subjects with mental illness
- •Subjects could not cooperate with the clinical trial personnel to finish trials
- •Existing disease (malignant tumor, autoimmune disease) or require the use of drugs (high-dose glucocorticoids, which is defined as accepting 40 mg or more daily prednisone or prednisone amount, period of two weeks or more) will affect the healing of the wound
- •For HIV positive patients, clinical diagnosis of patients with AIDS or the screening phase of neutrophil count (ANC) absolutely < 1000 cells/mm3
- •Subjects could not tolerate surgery
- •Subjects are unlikely to survive in the study period
- •The investigators think that who should not be included
- •Subjects are in or participated in other clinical researchers over the past 12 weeks
- •Subjects are participated in this trial at any time in the past
研究组 & 干预措施
Negative pressure wound therapy
Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.
干预措施: Negative pressure wound therapy (Procedure)
standard pressure bolster dressing
This method is traditional used in skin grafting wound.
干预措施: standard pressure bolster dressing (Procedure)
结局指标
主要结局
healing rate (the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements)
时间窗: postsurgery week 4
the percentage of subjects that achieved complete wound closure, complete wound closure is defined as skin complete reepithelialization without drainage or dressing requirements.
次要结局
- Skin graft survival rate(postsurgery week 2)
- VAS pain grade(postsurgery week 4)
研究者
Zhu Jiayuan
Professor, vice director of surgery
First Affiliated Hospital, Sun Yat-Sen University