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

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

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)