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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Healing; Prevention; Wound Healing Complication; Peripheral Occlusive Disease; Cold Atmospheric Plasma
• Intervention / Treatment: Device: Cold atmospheric plasma; Device: Sham device

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ursula EM Werra, MD; Phone Number: 0049+22147830757; Email: ursula.werra@uk-koeln.de

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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 Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to revision surgery due to inguinal wound healing complications	within 3 months postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ursula Werra
• Collaborators: Universitätsklinikum Hamburg-Eppendorf; neoplas med GmbH

Publications and helpful links

General Publications

• Werra UEM, Ahmad W, Schoepal M, Trinh TT, Dorweiler B. Intraoperative Application of Cold Atmospheric Plasma Reduces Inguinal Wound Healing Disorders-A Pilot Study. J Clin Med. 2025 Oct 24;14(21):7533. doi: 10.3390/jcm14217533.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: prevention; vascular surgery; wound healing disorder; cold atmospheric plasma; peripheral occlusive disease
• Other Study ID Numbers: PICPAD-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No