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

National Taiwan University

Status: Enrolling

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

Treatments: Device: Standard wound care; Device: Cold Atmospheric Plasma (CAP) Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07501897

202507066DIPA

Details and patient eligibility

About

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.

Full description

This study is a prospective, randomized controlled trial designed to evaluate the clinical efficacy and safety of cold atmospheric plasma (CAP) as an adjunctive therapy for wound management in patients receiving extracorporeal life support (ECLS). Cannulation site wounds in extracorporeal life support (ECLS) patients are frequently complicated by persistent bacterial colonization, biofilm formation, and impaired healing, which contribute to increased morbidity and healthcare burden.

Participants will be randomly assigned in a 1:1 ratio to receive either standard wound care alone or standard wound care combined with cold atmospheric plasma (CAP) treatment. cold atmospheric plasma (CAP) will be applied directly to the wound surface using an approved medical device at predefined intervals, in accordance with manufacturer guidelines and institutional protocols.

The study will incorporate multimodal assessments to comprehensively evaluate treatment effects. Quantitative bacterial burden will be assessed using fluorescence imaging techniques, supplemented by microbiological cultures. Local wound inflammation and healing responses will be evaluated through cytokine analysis of wound exudates. Clinical wound healing progression will be monitored using validated scoring systems, wound surface measurements, and documentation of time to complete epithelialization. The frequency of surgical debridement and incidence of clinically significant wound infections will also be recorded.

Safety will be closely monitored by documenting any adverse events associated with cold atmospheric plasma (CAP) application, including local skin reactions or discomfort. Outcome assessors will be blinded to treatment allocation where feasible to minimize bias.

This study seeks to determine whether cold atmospheric plasma (CAP) therapy can reduce microbial burden, modulate local inflammatory responses, and accelerate wound healing, thereby providing evidence for its potential integration into routine wound care practices for critically ill patients undergoing Extracorporeal Life Support (ECLS).

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Cold Atmospheric Plasma (CAP) + Standard Wound Care

Experimental group

Description:

Participants in this arm will receive standard. Extracorporeal Life Support(ECLS) wound care in addition to cold atmospheric plasma (CAP) treatment. cold atmospheric plasma (CAP) will be applied directly to the cannulation site wound using a CE/TFDA-approved medical device according to manufacturer guidelines. Treatment will be performed approximately 2-5 times per week, with an application duration of about 60-120 seconds per cm² of wound area. The procedure will be conducted by trained clinical personnel under sterile conditions. Standard wound care will include routine antiseptic dressing changes, maintenance of cannula site sterility, and systemic antibiotic therapy as clinically indicated. The combined approach aims to reduce bacterial burden, disrupt biofilm formation, modulate local inflammation, and promote wound healing.

Treatment:

Device: Cold Atmospheric Plasma (CAP) Therapy

Device: Standard wound care

Standard Wound Care

Placebo Comparator group

Description:

Participants in this arm will receive standard extracorporeal life support (ECLS)E wound care alone without cold atmospheric plasma (CAP) treatment. Standard care will follow institutional wound management protocols and may include routine antiseptic dressing changes, maintenance of sterility around the cannulation site, regular wound assessment, and systemic antibiotic therapy as clinically indicated. This arm serves as the comparator for evaluating the additional effect of cold atmospheric plasma (CAP) on wound infection, microbial burden, inflammation, and healing outcomes.

Treatment:

Device: Standard wound care