Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

214

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Enhet: 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
Sham-komparator: 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.
Enhet: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Time to revision surgery due to inguinal wound healing complications
Tidsramme: within 3 months postoperatively
within 3 months postoperatively

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ursula Werra

Samarbeidspartnere

Universitätsklinikum Hamburg-Eppendorf
neoplas med GmbH

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. februar 2029

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PICPAD-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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).

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere