Biofilm-Associated Infection, Delayed Wound Healing, ExtraCorporeal Life Support (ECLS), Surgical Site Infection, Wound Infection
Conditions
Keywords
Extracorporeal Life Support, cold atmospheric plasma
Brief 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.
Detailed 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).
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Due to the nature of the intervention, participants and treating clinicians will not be blinded to group allocation. However, outcome assessors-including wound care nurses evaluating clinical wound scores, microbiology personnel analyzing bacterial cultures, and laboratory staff measuring cytokine levels-will be blinded to treatment assignment where feasible. In addition, wound photographs and fluorescence imaging data will be assessed using standardized methods by blinded reviewers to minimize assessment bias.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the intervention group (standard wound care plus cold atmospheric plasma \[CAP\] treatment) or the control group (standard wound care alone). Both groups will be treated concurrently throughout the study period, with no crossover between groups. Randomization will be performed using a computer-generated sequence. Outcome assessments will be conducted by personnel blinded to group allocation where feasible to reduce bias.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Extracorporeal Life Support (ECLS) Cannulation Site Wound Infection | From Extracorporeal Life Support (ECLS) cannulation to wound closure or hospital discharge, whichever occurs first (up to 28 days) | 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. |
Countries
Taiwan
Contacts
CONTACTCHIH-YANG CHAN
Outcome results
None listed