NCT07501897

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	Cold 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.
DEVICE	Standard 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.

Timeline

• Start date: 2026-03-12
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Taiwan