An interventional study of Cold Atmospheric Plasma (CAP) Therapy and Standard wound care in ExtraCorporeal Life Support (ECLS), Wound Infection and Surgical Site Infection, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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).
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's planned enrollment of 65 is below the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
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.
Device: Cold Atmospheric Plasma (CAP) Therapy · Device: Standard wound care
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.
Device: Standard wound care
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.
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.
Incidence of Extracorporeal Life Support (ECLS) Cannulation Site Wound Infection
The proportion of participants who develop clinically significant wound infection at the Extracorporeal Life Support (ECLS) cannulation site during the study period. Infection will be defined by positive microbiological culture in conjunction with clinical signs and symptoms requiring antimicrobial treatment.
Time frame: From Extracorporeal Life Support (ECLS) cannulation to wound closure or hospital discharge, whichever occurs first (up to 28 days)
Plan to share: No — Individual participant data (IPD) generated from this study will not be publicly shared due to concerns regarding patient privacy, data confidentiality, and institutional regulations. Although all data will be de-identified, the study involves a relatively small and specific patient population, which may increase the risk of re-identification. Additionally, data sharing is subject to approval by the Institutional Review Board (IRB) and applicable data protection policies. Requests for access to limited, de-identified data may be considered on a case-by-case basis for legitimate academic or research purposes, subject to appropriate data use agreements and ethical approvals.
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