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

N/ANot Yet RecruitingNCT07571408

Ursula Werra214 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

214

Conditions

Peripheral Occlusive Disease

Interventions

Cold atmospheric plasmaDEVICE

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 deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)