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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ursula EM Werra, MD
- Número de telefone: 0049+22147830757
- E-mail: ursula.werra@uk-koeln.de
Locais de estudo
-
-
North Rhine-Westphalia
-
Cologne, North Rhine-Westphalia, Alemanha, 50937
- Department of Vascular and Endovascular Surgery
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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.
|
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
|
|
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.
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Time to revision surgery due to inguinal wound healing complications
Prazo: within 3 months postoperatively
|
within 3 months postoperatively
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of wound healing complications not requiring surgical revision
Prazo: within 3 months postoperatively
|
within 3 months postoperatively
|
|
|
Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)
Prazo: within 3 months postoperatively
|
within 3 months postoperatively
|
|
|
Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)
Prazo: within 3 months postoperatively
|
within 3 months postoperatively
|
|
|
course of patients quality of life over the course of wound healing
Prazo: 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). |
within 3 months postoperatively
|
|
course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
|
course of white blood cell count over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
|
course of C- reaktive protein over the course of wound healing
Prazo: 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)
|
within 3 months postoperatively
|
|
course of procalcitonin over the course of wound healing
Prazo: 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)
|
within 3 months postoperatively
|
|
course of hemoglobin over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
|
course of platelets over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
|
Course of haematocrit over the course of wound healing
Prazo: 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 (%)
|
within 3 months postoperatively
|
|
course of albumin over the course of wound healing
Prazo: 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)
|
within 3 months postoperatively
|
|
course of sodium over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
|
course of potassium over the course of wound healing
Prazo: 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)
|
within 3 months postoperatively
|
|
course of International Normalized Ratio (INR) over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
|
course of partial thromboplastin time over the course of wound healing
Prazo: 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)
|
within 3 months postoperatively
|
|
course of total cholersterol over the course of wound healing
Prazo: 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)
|
within 3 months postoperatively
|
|
course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing
Prazo: 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
|
within 3 months postoperatively
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- PICPAD-2026-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .