SAVE Studie- SArcoma Surgery with Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate the Wound Management in Sarcoma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Wound complication
研究概览
简要总结
The aim of this study is to evaluate local complications following sarcoma resection in the groin and thigh regions with regard to the planned wound closure method. To this end, temporary soft tissue coverage using a vacuum-assisted closure (VAC) system and delayed secondary closure with wound sutures and drainage placement will be compared to primary closure with drainage in terms of wound infections, revisions, and seroma formation.
详细描述
The study, "SAVE Study - SArcoma Surgery with Vacuum Enhanced Wound Treatment," is a prospective, ran-domized, controlled clinical trial aimed at comparing the effectiveness of two surgical approaches to optimize wound care following sarcoma resections. The study is designed as a multicenter trial.
The study includes two arms:
- Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.
- Control Group: In this group, wound closure is performed using primary sutures or staples, combined with the placement of a subcutaneous Redon drainage system.
The planned study start date is November 1, 2024. Before enrolling patients, all participating centers must have received approval from their ethics committees.
Initially, potential participants will be assessed for eligibility based on the inclusion and exclusion criteria. They will be educated about the study and provided with a standardized information sheet across all centers. After consent, they will be enrolled in the study.
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 must be over 18 years old.
- •Patients of any gender and background can be included.
- •The largest tumor diameter on imaging must be at least 5 cm. Preoperative imaging is required to assess tumor dimensions.
- •Sarcomas must be located in the lower extremity or groin.
- •Cases must be discussed preoperatively at an interdisciplinary tumor board.
- •Patients must provide informed consent to participate in the study.
排除标准
- •Tumors smaller than 5 cm and superficial masses.
- •Patients with local recurrences or prior wound healing complications in the surgical area.
- •Patients with ulcerating or infected tumors, or those requiring emergency surgery.
- •Other Soft Tissue Tumors such as Kaposi sarcoma.
- •for whom direct closure is not possible during the initial surgery due to the extent of resection.
结局指标
主要结局
Wound complication
时间窗: 3 Months
The primary objective of the study is to compare wound complications after vacuum therapy versus direct closure.
Wound Infection
时间窗: 3 Months
Wound Seroma
时间窗: 3 Months
Seroma in Wound
Lymphatic fistula
时间窗: 3 Months
Lymphatic fistula or Drainage secretion of \>50ml/24h after 5 postoperative days
Wound Dehiscence
时间窗: 3 Months
Wound dehiscence
Revision Surgery or conservative treatment
时间窗: 3 Months
If Revision surgery or antibiotic treatment is required due to a wound infection.
次要结局
- Risk factors for wound complications(3 Months)