Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUrsula Werra

About this trial

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.

Eligibility criteria

Qualifiers

Age > 18 years

Written informed consent

Surgical treatment of peripheral arterial occlusive disease (PAOD) with femoral (inguinal) access

Disqualifiers

Pregnancy or breastfeeding

Femoral access for an indication other than PAOD

Preoperative local infection or infectious skin disease

Life expectancy < 3 months

Trial design

Treatments tested in this trial

  • Cold atmospheric plasma
  • Sham device

Treatment groups

214 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ursula Werra

Lead sponsor

University of Cologne

Sponsor institution

neoplas med GmbH

Collaborator

Universitätsklinikum Hamburg-Eppendorf

Collaborator