Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complication… (NCT07571408) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease
Germany214 participantsStarted 2026-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to revision surgery due to inguinal wound healing complications