Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds
NCT ID: NCT05169814
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
40 participants
INTERVENTIONAL
2021-10-09
2027-06-01
Brief Summary
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Detailed Description
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After being informed about the study and potential risks, all patients will need to provide written informed consent before being included in the study. The characteristics of the wound will be assessed and measurements will be taken before and after treatment. Depending on the patient's wound type, the patient will be treated with MNBs in saline gauze which will be applied to the wound daily (for acute wounds), or MNBs in negative pressure wound therapy with instillation (NPWTi) (for chronic wounds) which will be applied to the wound continuously throughout the day with the wound evaluated and sponge replaced every 3-5 days. This is consistent with the current standard of wound care with gauze or NPWTi. Tissue oxygenation using infrared technology and wound healing will be measured and results collected for analysis.
Participation will last approximately 2-4 weeks or the duration of the inpatient admission. If discharge from the hospital is earlier than 2 weeks, the treatment will be discontinued and results will be submitted for analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Acute wounds: 1 control arm; 1 experimental arm (treated with MNB irrigation)
* Chronic wounds: 1 control arm; 1 experimental arm (treated with Negative pressure wound therapy with MNB instillation)
TREATMENT
DOUBLE
Study Groups
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Acute Wounds - Control
This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.
0.9% Normal Saline - Irrigation
A normal saline solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The normal saline solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.
Acute Wounds - Experimental
This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline.
Micro/nanobubble (MNB) - Irrigation
An MNB solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The MNB solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.
Chronic Wounds - Control
This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline.
0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)
NPWTi with normal saline will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.
Chronic Wounds - Experimental
This arm will include patients with chronic wounds and will receive experimental treatment: negative pressure wound therapy with instillation (NPWTi) using micro/nanobubbles (MNB's) in normal saline.
Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)
NPWTi with MNB will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.
Interventions
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Micro/nanobubble (MNB) - Irrigation
An MNB solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The MNB solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.
0.9% Normal Saline - Irrigation
A normal saline solution will be used as an irrigation solution to improve wound oxygenation in ischemic tissue (e.g. ischemic surgical tissue, traumatic wounds, and failing replants). The normal saline solution will be used in wet-to-dry wound care dressings with daily scheduled dressing changes.
Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)
NPWTi with MNB will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.
0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)
NPWTi with normal saline will be applied to the wound with 20-minute instillation periods every 3 hours (standard instillation settings) with dressing changes every 3-5 days.
Eligibility Criteria
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Inclusion Criteria
* have traumatic, surgical, or chronic wounds.
* have radiotherapy related tissue injury.
* have thermal, chemical, and/or electrical burn injuries.
* have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, and/or neuropathic skin ulcers.
* have acute ischemic wounds
Exclusion Criteria
* have wounds with exposed vital structures such as nerves, arteries, and/or veins.
* have wounds associated with malignancy.
18 Years
ALL
No
Sponsors
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University of California, Irvine
OTHER
Responsible Party
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Raj Vyas
Lead Investigator
Principal Investigators
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Raj Vyas, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman
Locations
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UCI Medical Center
Orange, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Tsuge H. Micro- and Nanobubbles: Fundamentals and Applications. Boca Raton: CRC Press; 2014.
Matiasek J, Djedovic G, Kiehlmann M, Verstappen R, Rieger UM. Negative pressure wound therapy with instillation: effects on healing of category 4 pressure ulcers. Plastic and Aesthetic Research. 2018;5.
Sayadi LR, Banyard DA, Ziegler ME, Obagi Z, Prussak J, Klopfer MJ, Evans GR, Widgerow AD. Topical oxygen therapy & micro/nanobubbles: a new modality for tissue oxygen delivery. Int Wound J. 2018 Jun;15(3):363-374. doi: 10.1111/iwj.12873. Epub 2018 Jan 5.
Khan MS, Hwang J, Lee K, Choi Y, Kim K, Koo HJ, Hong JW, Choi J. Oxygen-Carrying Micro/Nanobubbles: Composition, Synthesis Techniques and Potential Prospects in Photo-Triggered Theranostics. Molecules. 2018 Aug 31;23(9):2210. doi: 10.3390/molecules23092210.
Lalezari S, Lee CJ, Borovikova AA, Banyard DA, Paydar KZ, Wirth GA, Widgerow AD. Deconstructing negative pressure wound therapy. Int Wound J. 2017 Aug;14(4):649-657. doi: 10.1111/iwj.12658. Epub 2016 Sep 29.
Back DA, Scheuermann-Poley C, Willy C. Recommendations on negative pressure wound therapy with instillation and antimicrobial solutions - when, where and how to use: what does the evidence show? Int Wound J. 2013 Dec;10 Suppl 1(Suppl 1):32-42. doi: 10.1111/iwj.12183.
Jarbrink K, Ni G, Sonnergren H, Schmidtchen A, Pang C, Bajpai R, Car J. The humanistic and economic burden of chronic wounds: a protocol for a systematic review. Syst Rev. 2017 Jan 24;6(1):15. doi: 10.1186/s13643-016-0400-8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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154138
Identifier Type: OTHER
Identifier Source: secondary_id
5901
Identifier Type: -
Identifier Source: org_study_id
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