Exploring the Effectiveness of Unpowered Negative Pressure Wound Therapy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- wound healing
研究概览
简要总结
The aim of this study is to investigate the effectiveness of Non-powered Negative Pressure Wound Therapy (NPWT) on the healing of abdominal surgical wounds. It is designed as a randomized controlled trial with an experimental group (using NPWT) and a control group (conventional wound care). The study aims to recruit 160 participants: 80 with acute wounds and 80 with chronic wounds. Participants will be randomly assigned to either the experimental group (40 acute wounds, 40 chronic wounds) or the control group (40 acute wounds, 40 chronic wounds). The study will assess wound healing rates and speed, quality of life, self-perceived health status, pain levels, complications, and wound care costs using indicators. Effectiveness will be analyzed using Generalized Estimating Equations (GEE). The study anticipates that results will contribute to evaluating the effects of Non-powered NPWT on wound healing, quality of life, pain, and cost-effectiveness in patients with acute and chronic wounds.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute wounds (wound duration <4 weeks) or chronic wounds (wound duration ≥4 weeks).
- •Wound depth <2 cm.
- •Age ≥18 years.
- •Patients who have been evaluated and approved for participation by their attending physician.
排除标准
- •Patients with unstable vital signs.
- •Presence of ischemia in the wound or surrounding tissues.
- •Fragile skin around the wound.
- •Severe wound infection or necrotic tissue.
- •Wound size >10 × 20 cm.
研究组 & 干预措施
NPWT
The NPWT group (experimental group) will include 80 participants. Wounds will be cleansed with sterile normal saline, followed by wound assessment and documentation. The Anscare SIMO Negative Pressure Wound Therapy (NPWT) System, a non-powered NPWT dressing, will then be applied.
干预措施: NPWT (Other)
standard care group
Thestandard care group will include 80 participants. Wounds will be cleansed with sterile normal saline and receive routine wound care, followed by wound assessment and documentation.
干预措施: standard care group (Other)
结局指标
主要结局
wound healing
时间窗: 90days
1. Wound size will be measured before and after the intervention, using a ruler and photographic records. 2. The occurrence and time of healing events will be documented. The modified TIME-H score will be used as the evaluation tool. This scoring system includes four main indicators: T (Tissue)、I (Infection)、M (Moisture)、E (Edge)、H (Healing).
次要结局
- Pain Assessment(90days)
- Cost Analysis(90days)
- Complications and Adverse Events(90days)
- Adhesion Issues for Dressing(90days)
- Mortality Events(90days)
- Wound-related Quality of Life(90days)
- Self-reported Health Status(90days)
- Length of Hospital Stay for wound treatment(90days)