Clinical Trial

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

Study acronym: PICPAD
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07571408
Lead Sponsor Ursula Werra
Collaborators: neoplas med GmbH, Universitätsklinikum Hamburg-Eppendorf
Conditions Peripheral Occlusive Disease, Wound Healing, Wound Healing Complication, Cold Atmospheric Plasma, Prevention
Enrollment 214 participants
Start Date 2026-11-01
Primary Completion 2029-02-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-06