Randomised Controlled Study to Evaluate the Efficacy of the Treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) After Surgery by Application of Negative Pressure Wound Therapy (NPWT) in Comparison to Standard Conventional Wound Therapy (SCWT) of the Clinical Routine.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 67
- 主要终点
- Wound closure
研究概览
简要总结
The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW).
详细描述
The aim of the study is the comparison between NPWT and Standard Conventional Wound Therapy (SCWT) under clinical, safety and economic aspects in the treatment of postoperative Iatrogenic Subcutaneous Abdominal Wounds (ISAW). The hypothesis is based on the assumption that the application of NPWT for the treatment of postoperative abdominal wound healing impairments (with intact fascia) results in a decrease of time until achievement of wound closure (with confirmation after 30 consecutive days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.
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
- •Acute subcutaneous abdominal wound-healing impairment after surgical intervention
- •Sizes of wound opening (maximum diameter ≥ 3 cm)
- •Wound surface ≥ 9 qcm
排除标准
- •Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
- •Existence of an open abdominal fascia
- •Acute serious organ failure
- •Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
- •Ongoing / during 3 weeks after chemo therapy
- •Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies
研究组 & 干预措施
Negative Pressure Wound Therapy
Used therapy systems
干预措施: Negative Pressure Wound Therapy (Device)
Standard Conventional Wound Therapy
Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
干预措施: Standard Wound Therapy (Other)
结局指标
主要结局
Wound closure
时间窗: within 42 days of treatment
Time-of-closure (in days) achieved and confirmed wound closures and rate-of-closure (in number). The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. The closure must remain at least for a period of 30 days.
次要结局
- Serious adverse events(within the observation period of 180 days)
- Wound volume(within the observation period of 180 days)
- Wound infections(within the observation period of 180 days)
- Recurrences(wthin observation period of 180 days)
- Quality of Life(within observation period of 180 days)
- Direct costs(within a maximum treatment time of 42 days or until end of therapy)
- Pain(within a maximum treatment time of 42 days)
- Indirect costs(within a maximum treatment time of 42 days or until end of therapy)
- Adverse events(within a maximum treatment time of 42 days)
研究者
Dr. Marcus Redaèlli
Administative and scientific head of staffed offices of Interdisciplinary Centre for Health Services Research
University of Witten/Herdecke