Prophylactic Application of Cold Atmospheric Plasma to Reduce Postoperative Wound Healing Disorders in the Inguinal Region in High-risk Patients With Peripheral Arterial Occlusive Disease- Intraoperative Application of Cold Atmospheric Plasma in the Inguinal Region
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Time to revision surgery due to inguinal wound healing complications
研究概览
简要总结
The goal of this clinical trial is to learn if postoperative wound complications in the inguinal region of high-risk patients with peripheral arterial occlusive disease can be prevented by the intraoperative application of cold atmospheric plasma.
The main questions it aims to answer are:
Does the intraoperative application of cold atmospheric plasma reduce the need for surgical revision of inguinal wounds due to wound healing complications within 3 months postoperatively? Does the intraoperative application of cold atmospheric plasma reduce wound healing complications not requiring revision within 3 months postoperatively?
Researchers will compare the application of cold atmospheric plasma to a placebo (a deactivated look-alike device).
Participants will:
Undergo surgical treatment with femoral artery access due to their peripheral arterial occlusive disease, in accordance with the respective vascular surgery department standard of care.
Receive a single application of cold atmospheric plasma or, respectively, placebo in the area of their inguinal access wound during surgery (after subcutaneous closure and prior to skin closure).
Be regularly assessed for wound healing during the first postoperative 14 days as part of routine clinical care and undergo a final evaluation at 3 months. They will also be surveyed regarding their quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age > 18 years
- •Written informed consent
- •Surgical treatment of peripheral arterial occlusive disease (PAOD) with femoral (inguinal) access
- •High-risk patient for wound healing complications:
- •WHD (wound healing disorder) score ≥ 4 points:
- •Diabetes mellitus (2) Immunosuppression/steroid therapy (2) End-stage renal disease (2) Reinterventions (2) Peripheral arterial occlusive disease (1) Nicotine abuse (1) Obesity (BMI > 30) (1) Age > 80 years (1) Duration of surgery > 4 h (1) Blood loss > 1.5 L (1) Local radiotherapy/chemotherapy (1)
排除标准
- •Pregnancy or breastfeeding
- •Femoral access for an indication other than PAOD
- •Preoperative local infection or infectious skin disease
- •Life expectancy < 3 months
- •Active infection of the ipsilateral extremity requiring systemic antibiotic therapy at the time of surgery
- •Systemic antibiotic therapy at the time of surgery
- •Use of coated incisional drapes (e.g., iodine-impregnated)
- •Intraoperative use of anti-infective topical agents (e.g., Gentacoll, doxycycline, etc.)
- •Use of fibrin sealants/thrombogenic adhesive substances above the fascia Planned postoperative prophylactic negative pressure wound therapy (NPWT)
研究组 & 干预措施
Intervention: Intraoperative application of cold atmospheric plasma
During surgery (after subcutaneous closure and prior to skin closure), patients receive a single application of cold atmospheric plasma in the area of their inguinal access wound.
干预措施: Cold atmospheric plasma (Device)
Control: Intraoperative sham application mimicking cold atmospheric plasma
During surgery (after subcutaneous closure and prior to skin closure), patients receive a sham application mimicking cold atmospheric plasma in the area of the inguinal access wound.
干预措施: Sham device (Device)
结局指标
主要结局
Time to revision surgery due to inguinal wound healing complications
时间窗: within 3 months postoperatively
次要结局
- Number of wound healing complications not requiring surgical revision(within 3 months postoperatively)
- Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)(within 3 months postoperatively)
- Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)(within 3 months postoperatively)
- course of patients quality of life over the course of wound healing(within 3 months postoperatively)
- course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing(within 3 months postoperatively)
- course of white blood cell count over the course of wound healing(within 3 months postoperatively)
- course of C- reaktive protein over the course of wound healing(within 3 months postoperatively)
- course of procalcitonin over the course of wound healing(within 3 months postoperatively)
- course of hemoglobin over the course of wound healing(within 3 months postoperatively)
- course of platelets over the course of wound healing(within 3 months postoperatively)
- Course of haematocrit over the course of wound healing(within 3 months postoperatively)
- course of albumin over the course of wound healing(within 3 months postoperatively)
- course of sodium over the course of wound healing(within 3 months postoperatively)
- course of potassium over the course of wound healing(within 3 months postoperatively)
- course of International Normalized Ratio (INR) over the course of wound healing(within 3 months postoperatively)
- course of partial thromboplastin time over the course of wound healing(within 3 months postoperatively)
- course of total cholersterol over the course of wound healing(within 3 months postoperatively)
- course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing(within 3 months postoperatively)
研究者
Ursula Werra
consultant vascular surgeon
University of Cologne