RecruitingNot ApplicableNCT07501897

Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Following Extracorporeal Life Support

Sponsor

National Taiwan University Hospital

Enrollment

65 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

Surgical Site Infection Wound Infection Delayed Wound Healing ExtraCorporeal Life Support (ECLS)Biofilm-Associated Infection

Summary

This study aims to evaluate a new wound treatment called cold atmospheric plasma (CAP) for patients receiving extracorporeal life support (ECLS). Patients on extracorporeal life support (ECLS) often develop wounds at the sites where tubes are inserted, and these wounds can be difficult to heal and prone to infection. cold atmospheric plasma (CAP) is a gentle, non-heat treatment that can kill bacteria, reduce inflammation, and promote wound healing. In this study, patients will be randomly assigned to receive either standard wound care alone or standard care plus cold atmospheric plasma (CAP) treatment. Researchers will compare both groups to see whether cold atmospheric plasma (CAP) can reduce infection, improve healing speed, and decrease the need for additional procedures. The study will also monitor safety to ensure the treatment is well tolerated. The goal is to find a more effective and safe way to improve wound healing in critically ill patients.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age ≥ 18 years
Receiving extracorporeal life support (ECLS)
Presence of cannulation site wound requiring wound care

Exclusion Criteria4

Pre-existing severe dermatological conditions at the cannulation site
Severe coagulopathy precluding local intervention
Concurrent receipt of other experimental wound treatments
Life expectancy \< 48 hours

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Interventions

DEVICECold Atmospheric Plasma (CAP) Therapy

Cold atmospheric plasma (CAP) therapy is a non-thermal, non-invasive treatment that delivers ionized gas containing reactive oxygen and nitrogen species (RONS), ultraviolet photons, and transient electric fields to the wound surface. In this study, Cold atmospheric plasma (CAP) will be applied directly to extracorporeal life support (ECLS) cannulation site wounds using a CE/TFDA-approved medical device, following manufacturer-recommended parameters (approximately 60-120 seconds per cm² per session, administered 2-5 times per week). The treatment is performed under sterile conditions by trained clinical personnel and is used as an adjunct to standard wound care. Cold atmospheric plasma (CAP) is designed to reduce microbial load, including biofilm-associated organisms, modulate local inflammatory responses, and promote tissue regeneration without causing thermal damage to surrounding healthy tissue.

DEVICEStandard wound care

Standard wound care consists of routine management of extracorporeal life support (ECLS) cannulation site wounds according to institutional protocols. This includes regular antiseptic dressing changes (e.g., chlorhexidine- or povidone-iodine-based solutions), maintenance of a sterile environment around the cannulation site, and careful monitoring for signs of infection or complications. Additional care may include wound cleaning, debridement as clinically indicated, and the use of systemic antibiotics based on clinical judgment and microbiological findings. All procedures are performed by trained healthcare professionals following established clinical guidelines to support wound healing and prevent infection.