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| Name | Class |
|---|---|
| neoplas med GmbH | UNKNOWN |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Intraoperative application of cold atmospheric plasma | Active Comparator | 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. |
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| Control: Intraoperative sham application mimicking cold atmospheric plasma | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to revision surgery due to inguinal wound healing complications | within 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ursula EM Werra, MD | Contact | 0049+22147830757 | ursula.werra@uk-koeln.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular and Endovascular Surgery | Cologne | North Rhine-Westphalia | 50937 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41226930 | Background | 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. |
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Individual participant data will not be made publicly available. Data will be used solely for the purposes of this study and will be processed in accordance with applicable data protection regulations (GDPR). Statistical analysis will be performed by an independent academic biostatistics institute (Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf).
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| 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 |
|
| 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 | 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). | within 3 months postoperatively |
| course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing | 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 | within 3 months postoperatively |
| course of white blood cell count over the course of wound healing | 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 | within 3 months postoperatively |
| course of C- reaktive protein over the course of wound healing | 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) | within 3 months postoperatively |
| course of procalcitonin over the course of wound healing | 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) | within 3 months postoperatively |
| course of hemoglobin over the course of wound healing | 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 | within 3 months postoperatively |
| course of platelets over the course of wound healing | 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 | within 3 months postoperatively |
| Course of haematocrit over the course of wound healing | 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 (%) | within 3 months postoperatively |
| course of albumin over the course of wound healing | 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) | within 3 months postoperatively |
| course of sodium over the course of wound healing | 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 | within 3 months postoperatively |
| course of potassium over the course of wound healing | 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) | within 3 months postoperatively |
| course of International Normalized Ratio (INR) over the course of wound healing | 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 | within 3 months postoperatively |
| course of partial thromboplastin time over the course of wound healing | 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) | within 3 months postoperatively |
| course of total cholersterol over the course of wound healing | 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) | within 3 months postoperatively |
| course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing | 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 | within 3 months postoperatively |