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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)

4 maggio 2026 aggiornato da: Ursula Werra

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

214

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Germania
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germania, 50937
        • Department of Vascular and Endovascular Surgery

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Dispositivo: Cold atmospheric plasma
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
Comparatore fittizio: 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.
Dispositivo: Sham 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Time to revision surgery due to inguinal wound healing complications
Lasso di tempo: within 3 months postoperatively
within 3 months postoperatively

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of wound healing complications not requiring surgical revision
Lasso di tempo: within 3 months postoperatively
within 3 months postoperatively
Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)
Lasso di tempo: within 3 months postoperatively
within 3 months postoperatively
Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)
Lasso di tempo: within 3 months postoperatively
within 3 months postoperatively
course of patients quality of life over the course of wound healing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ursula Werra

Collaboratori

Universitätsklinikum Hamburg-Eppendorf
neoplas med GmbH

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 febbraio 2029

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • PICPAD-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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