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

• Cold atmospheric plasma (Device): 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
• Sham device (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

Primary outcomes

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

Secondary outcomes

• 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]: Patients will be provided with the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionnaire in order to assess quality of life at the baseline visit as well as follow-up visits 3 and 4 and after 3 months (end of study visit). The EQ-5D-5L will be evaluated by converting responses across its five domains-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-into a single health utility index using a country-specific value set (e.g., German tariff), with possible values typically ranging from below 0 (worse than death) to 1 (full health). Each domain is rated on a 5-level scale, where 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems/unable to perform. In addition, the EQ Visual Analogue Scale (EQ VAS) score will be analyzed separately, ranging from 0 (worst imaginable health) to 100 (best imaginable health).
• course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: eGFR ml/min/1.73m²
• course of white blood cell count over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: white blood cell count 10*9/L
• course of C- reaktive protein over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: C- reaktive protein (mg/L)
• course of procalcitonin over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: procalcitonin (ng/ml)
• course of hemoglobin over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: hemoglobin g/dl
• course of platelets over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: platelets 10*9/L
• Course of haematocrit over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: haematocrit (%)
• course of albumin over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: albumin (g/L)
• course of sodium over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: sodium mmol/L
• course of potassium over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: potassium (mmol/L)
• course of International Normalized Ratio (INR) over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: INR
• course of partial thromboplastin time over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case:partial thromboplastin time (s)
• course of total cholersterol over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: total cholesterol (mg/dl)
• course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing [within 3 months postoperatively]: According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: LDL cholesterol

Sex: All, ages: 18 Years to any

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)

• 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