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

NCT07571408 | Not Yet Recruiting

• 1 other identifier: PICPAD-2026-01
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Occlusive Disease; Wound Healing; Wound Healing Complication; Cold Atmospheric Plasma; Prevention

Keywords

cold atmospheric plasma; prevention; wound healing disorder; vascular surgery; peripheral occlusive disease

Outcome Measures

Primary Outcomes (1)

• Time to revision surgery due to inguinal wound healing complications

  within 3 months postoperatively

Secondary Outcomes (18)

• 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

  within 3 months postoperatively

• course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing

  within 3 months postoperatively

Study Arms (2)

Intervention: Intraoperative application of cold atmospheric plasma

ACTIVE COMPARATOR

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

Control: Intraoperative sham application mimicking cold atmospheric plasma

SHAM COMPARATOR

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

Interventions

Cold atmospheric plasma DEVICE

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

Intervention: Intraoperative application of cold atmospheric plasma

Sham device 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

Control: Intraoperative sham application mimicking cold atmospheric plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ursula Werra: lead
• neoplas med GmbH: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

Department of Vascular and Endovascular Surgery

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

• 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.

  PMID: 41226930 BACKGROUND

Central Study Contacts

Ursula EM Werra, MD

CONTACT

0049+22147830757; ursula.werra@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant vascular surgeon

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)