Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease (PICPAD)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ursula EM Werra, MD
- Número de teléfono: 0049+22147830757
- Correo electrónico: ursula.werra@uk-koeln.de
Ubicaciones de estudio
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North Rhine-Westphalia
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Cologne, North Rhine-Westphalia, Alemania, 50937
- Department of Vascular and Endovascular Surgery
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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
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Comparador falso: 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.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Time to revision surgery due to inguinal wound healing complications
Periodo de tiempo: within 3 months postoperatively
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within 3 months postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of wound healing complications not requiring surgical revision
Periodo de tiempo: within 3 months postoperatively
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within 3 months postoperatively
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Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)
Periodo de tiempo: within 3 months postoperatively
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within 3 months postoperatively
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Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)
Periodo de tiempo: within 3 months postoperatively
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within 3 months postoperatively
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course of patients quality of life over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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course of white blood cell count over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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course of C- reaktive protein over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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)
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within 3 months postoperatively
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course of procalcitonin over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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)
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within 3 months postoperatively
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course of hemoglobin over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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course of platelets over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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Course of haematocrit over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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 (%)
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within 3 months postoperatively
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course of albumin over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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)
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within 3 months postoperatively
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course of sodium over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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course of potassium over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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)
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within 3 months postoperatively
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course of International Normalized Ratio (INR) over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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course of partial thromboplastin time over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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)
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within 3 months postoperatively
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course of total cholersterol over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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)
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within 3 months postoperatively
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course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing
Periodo de tiempo: within 3 months postoperatively
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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
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within 3 months postoperatively
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PICPAD-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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