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
Sponsors and collaborators
Ursula Werra
Lead sponsor
University of Cologne
Sponsor institution
neoplas med GmbH
Collaborator
Universitätsklinikum Hamburg-Eppendorf
Collaborator