The Comparison of Negative Pressure Wound Therapy (NPWT) and Conventional Moist Dressings in the Wound Bed Preparation for Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the time to STSG surgery
研究概览
简要总结
The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.
详细描述
The diabetic foot ulcers (DFUs) are major complications of patients with diabetes mellitus. Split thickness skin graft (STSG) surgery is a cost-effective method for the rapid healing of DFUs. The aim of this study was to compare the efficacy of negative pressure wound therapy (NPWT) using vacuum-assisted closure (VAC) device versus conventional moist dressings (alginates) on the wound bed preparation prior to STSG surgery for patients with chronic DFUs.
This ia a prospective, randomized controlled trial. All the patients were randomly divided into two groups: the NPWT group or the control group. Once the DFUs wound was filled with healthy granulation tissues, STSG surgery was performed. The primary endpoint included the time to STSG surgery (the duration from first surgical debridement to STSG surgery). The secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (NETs) formation, and polarization of M1 or M2 macrophages in the DFUs wounds of the two groups.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DFUs aged 20-80 years.
- •Wagner grade 2 to
- •Chronic DFUs wounds (duration of disease ≥ 2 weeks).
- •Ankle brachial ratio (ABI) 0.5～0.9, wound area 8~20 cm2.
排除标准
- •Patients who were unable to complete the follow-up were not included,
- •Pregnant or nursing mothers were not included.
- •Patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
- •Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
- •Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.
结局指标
主要结局
the time to STSG surgery
时间窗: 3 months post debridement
the duration from first surgical debridement to STSG surgery
次要结局
- the wound blood perfusion(Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).)
- the wound neutrophil extracellular traps (NETs) formation(Before the radical surgical debridement (Day 0), After NPWT or conventional dressing change therapy for 6 days (Day 6).)
研究者
YinWu
attending doctor of Department of Burn and Plastic Surgery,Nanjing First Hospital
Nanjing First Hospital, Nanjing Medical University