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

NCT07501897 | Recruiting

• 1 other identifier: 202507066DIPA
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Extracorporeal Life Support; cold atmospheric plasma

Outcome Measures

Primary Outcomes (1)

• 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.

  From Extracorporeal Life Support (ECLS) cannulation to wound closure or hospital discharge, whichever occurs first (up to 28 days)

Study Arms (2)

Cold Atmospheric Plasma (CAP) + Standard Wound Care

EXPERIMENTAL

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

Standard Wound Care

PLACEBO COMPARATOR

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

Interventions

Cold Atmospheric Plasma (CAP) Therapy DEVICE

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.

Cold Atmospheric Plasma (CAP) + Standard Wound Care

Standard wound care DEVICE

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.

Cold Atmospheric Plasma (CAP) + Standard Wound Care; Standard Wound Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Wound Infection; Surgical Wound Infection

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

CHIH-YANG CHAN

CONTACT

+886-975810806; chanchihyang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 30, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)