Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Cold atmospheric plasma
  Single intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with cold atmospheric plasma after subcutaneous closure and prior to skin closure
• Устройство Sham device
  Single intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with sham device after subcutaneous closure and prior to skin closure

Первичные конечные точки

• Time to revision surgery due to inguinal wound healing complications [Срок оценки: within 3 months postoperatively]

Вторичные конечные точки (12)

• Number of wound healing complications not requiring surgical revision [Срок оценки: within 3 months postoperatively]
• Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke) [Срок оценки: within 3 months postoperatively]
• Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization) [Срок оценки: within 3 months postoperatively]
• course of patients quality of life over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of white blood cell count over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of C- reaktive protein over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of procalcitonin over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of hemoglobin over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of platelets over the course of wound healing [Срок оценки: within 3 months postoperatively]
• Course of haematocrit over the course of wound healing [Срок оценки: within 3 months postoperatively]
• course of albumin over the course of wound healing [Срок оценки: within 3 months postoperatively]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Германия · 1 центр

• Department of Vascular and Endovascular Surgery — Cologne

Публикации

• Werra UEM, Ahmad W, Schoepal M, Trinh TT, Dorweiler B. Intraoperative Application of Cold Atmospheric Plasma Reduces Inguinal Wound Healing Disorders-A Pilot Study. J Clin Med. 2025 Oct 24;14(21):7533. doi: 10.3390/jcm14217533. PMID 41226930

Идентификаторы

NCT: NCT07571408 · PICPAD-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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