ExtraCorporeal Life Support (ECLS)NCT07501897
Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Following Extracorporeal Life Support
A study testing Cold Atmospheric Plasma (CAP) Therapy and Standard wound care in people with ExtraCorporeal Life Support (ECLS) and Wound Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ExtraCorporeal Life Support (ECLS), Wound Infection, Surgical Site Infection
- What is being tested?
- Cold Atmospheric Plasma (CAP) Therapy and Standard wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Receiving extracorporeal life support (ECLS)
- Presence of cannulation site wound requiring wound care
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
CHIH-YANG CHAN, +886-972651147, chanchihyang@gmail.com
About this study
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.
Read more
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.
Read the 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
- Being tested
- Cold Atmospheric Plasma (CAP) Therapy, Standard wound care
- Keywords
- Extracorporeal Life Support, cold atmospheric plasma
- Medical subject headings
- Wound Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Atmospheric Plasma (CAP) TherapyDevice
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 careDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Extracorporeal Life Support (ECLS) cannulation to wound closure or hospital discharge, whichever occurs first (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start12 Mar 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtraCorporeal Life Support (ECLS)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501897
- Sponsor's protocol ID
- 202507066DIPA
- Status last verified
- Nov 2025
- First submitted
- 18 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Cold Atmospheric Plasma Treatment on Wound Healing at Cannulation Sites in Patients Following Extracorporeal Life Support
- ClinicalTrials.gov ID
- NCT07501897
- Acronym / sponsor ID
- 202507066DIPA
- Conditions
- ExtraCorporeal Life Support (ECLS), Wound Infection, Surgical Site Infection, Delayed Wound Healing, Biofilm-Associated Infection
- Keywords
- Extracorporeal Life Support, cold atmospheric plasma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Atmospheric Plasma (CAP) + Standard Wound Care | Experimental | Device: Cold Atmospheric Plasma (CAP) Therapy, Device: Standard wound careParticipants 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. |
| Standard Wound Care | Placebo comparator | Device: Standard wound careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Receiving extracorporeal life support (ECLS)
- Presence of cannulation site wound requiring wound care
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Atmospheric Plasma (CAP) TherapyCold 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 | Cold Atmospheric Plasma (CAP) + Standard Wound Care |
| Standard wound careStandard 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. | Device | Cold Atmospheric Plasma (CAP) + Standard Wound Care, Standard Wound Care |
Primary outcome
Incidence of Extracorporeal Life Support (ECLS) Cannulation Site Wound Infection
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: 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.
Related trials for ExtraCorporeal Life Support (ECLS)
RecruitingPhase 1
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
RecruitingObservational study
Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)
Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication
Active, not recruitingObservational study
ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruiting
Ultraprotective Lung Ventilation With Respiratory Extracorporeal Life Support for ARDS
Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Pharmacokinetic Modelling of Levosimendan in Adults
Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Atmospheric Plasma (CAP) Therapy and Standard wound care in people with ExtraCorporeal Life Support (ECLS) and Wound Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHIH-YANG CHAN (+886-975810806, chanchihyang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Extracorporeal Life Support (ECLS) Cannulation Site Wound Infection (time frame: From Extracorporeal Life Support (ECLS) cannulation to wound closure or hospital discharge, whichever occurs first (up to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.