Open WoundEarly Phase 1MNBNCT05169814
Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds
A Early Phase 1 study testing Micro/nanobubble (MNB) - Irrigation, 0.9% Normal Saline - Irrigation and Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi) in people with Open Wound and Wound Heal, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of Micro/nanobubbles (MNB's) for the healing of acute and chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Wound, Wound Heal
- What is being tested?
- Micro/nanobubble (MNB) - Irrigation, 0.9% Normal Saline - Irrigation and Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2021to 1 Jun 2027
- Phase
- Early Phase 1
- 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
- are above the age of 18.
- 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
Who cannot join
- have infected wounds.
- have wounds with exposed vital structures such as nerves, arteries, and/or veins.
- have wounds associated with malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCI Medical Center
Orange, California, 92868
Leonardo Alaniz, MD, 602-318-7118, alanizl1@hs.uci.edu
Lohrasb R Sayadi, MD, (949) 209-7267, rsayadi@uci.edu
About this study
Official title: Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds
The purpose of this study is to assess the safety and efficacy of Micro/nanobubbles (MNB's) for the healing of acute and chronic wounds.
Read the detailed description
Oxygen delivery is one of the primary factors in wound healing. Micro/nanobubbles (MNBs) can be used to increase the oxygen dissolved in solution and increase oxygen delivery to a wound. The purpose of this research study is to determine if MNBs applied to a wound improve wound healing.
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
- Open Wound, Wound Heal
- Being tested
- Micro/nanobubble (MNB) - Irrigation, 0.9% Normal Saline - Irrigation, Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi), 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)
- Keywords
- acute wounds, chronic wounds, MNB solution, MNB, Micro/nanobubbles, Micronanobubbles, negative pressure wound therapy with instillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro/nanobubble (MNB) - IrrigationDrug
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 - IrrigationOther
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)Drug
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Wounds - Control | Placebo comparator | This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline. Receives: Other: 0.9% Normal Saline - Irrigation |
| Acute Wounds - Experimental | Experimental | This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline. Receives: Drug: Micro/nanobubble (MNB) - Irrigation |
| Chronic Wounds - Control | Placebo comparator | This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline. Receives: Other: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi) |
| Chronic Wounds - Experimental | 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. Receives: Drug: Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound total oxygen saturation level
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxygenation saturation levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen saturation measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.
Measured: 2-4 weeks
Wound Size/ Surface Area (cm^2)
Daily photographs taken before initiation of treatment and during treatment.
Measured: 2-4 weeks
Analysis of wound pH
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups, and a pH strip will be used to measure the pH.
Measured: 2-4 weeks
Wound oxyhemoglobin concentration level
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.
Measured: 2-4 weeks
Wound deoxyhemoglobin concentration level
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound deoxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.
Measured: 2-4 weeks
Analysis of wound GM-CSF concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GM-CSF concentration levels.
Measured: 2-4 weeks
Analysis of wound interferon concentration levels
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interferon concentration levels: IFN alpha, IFN gamma.
*These levels will be reported in the same units of measure.
Measured: 2-4 weeks
Analysis of wound interleukin (IL) concentration levels
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interleukin concentration levels: IL-1 alpha, IL-1 beta, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A (CTLA-8), IL-18, IL-21, IL-22, IL-23, IL-27, IL-31.
*These levels will be reported in the same units of measure.
Measured: 2-4 weeks
Analysis of wound tumor necrosis factor (TNF) concentration levels
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following TNF concentration levels: TNF alpha, TNF beta.
*These levels will be reported in the same units of measure.
Measured: 2-4 weeks
Analysis of wound Eotaxin (CCL11) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess Eotaxin (CCL11) concentration levels.
Measured: 2-4 weeks
Analysis of wound GRO alpha (CXCL1) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GRO alpha (CXCL1) concentration levels.
Measured: 2-4 weeks
Analysis of wound IP-10 (CXCL10) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess IP-10 (CXCL10) concentration levels.
Measured: 2-4 weeks
Analysis of wound MCP-1 (CCL2) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MCP-1 (CCL2) concentration levels.
Measured: 2-4 weeks
Analysis of wound MIP-1 alpha (CCL3) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 alpha (CCL3) concentration levels.
Measured: 2-4 weeks
Analysis of wound MIP-1 beta (CCL4) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 beta (CCL4) concentration levels.
Measured: 2-4 weeks
Analysis of wound RANTES (CCL5) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess RANTES (CCL5) concentration levels.
Measured: 2-4 weeks
Analysis of wound SDF-1 alpha concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess SDF-1 alpha concentration levels.
Measured: 2-4 weeks
Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP1 concentration level.
Measured: 2-4 weeks
Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP8 concentration level.
Measured: 2-4 weeks
Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP 13 concentration level.
Measured: 2-4 weeks
Secondary outcomes (3)
Hospital Length of Stay (LOS)
Days of hospital admission
Measured: 2-4 weeks
Number of participants that return to the operating room
Qualifying individuals include participants that return to the operating room for a procedure (e.g. surgical debridement) on the same wound being treated by the study investigators.
Measured: 2-4 weeks
Number of participants readmitted to the hospital for same wound after discharge
Qualifying individuals include participants that are readmitted to the hospital for the same wound that was treated by the study investigators.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start9 Oct 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Open WoundStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot study that consists of 4 arms: * 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raj Vyas, University of California, Irvine
- Investigators
- Raj Vyas, MD, Principal investigator, University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169814
- Sponsor's protocol ID
- 5901
- Other IDs
- 154138
- Acronym
- MNB
- Status last verified
- Jun 2025
- First submitted
- 4 Nov 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD with other researchers outside this study.
Publications
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.
PubMed 29314626Khan 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.
PubMed 30200336Lalezari 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.
PubMed 27681204Back 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.
PubMed 24251842Jarbrink 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.
PubMed 28118847
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT05169814
- Acronym / sponsor ID
- MNB / 5901
- Conditions
- Open Wound, Wound Heal
- Keywords
- acute wounds, chronic wounds, MNB solution, MNB, Micro/nanobubbles, Micronanobubbles, negative pressure wound therapy with instillation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Dec 2021 (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.
The purpose of this study is to assess the safety and efficacy of Micro/nanobubbles (MNB's) for the healing of acute and chronic wounds.
Detailed description
Oxygen delivery is one of the primary factors in wound healing. Micro/nanobubbles (MNBs) can be used to increase the oxygen dissolved in solution and increase oxygen delivery to a wound. The purpose of this research study is to determine if MNBs applied to a wound improve wound healing.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a pilot study that consists of 4 arms: * 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)
| Arm | Type | Receives |
|---|---|---|
| Acute Wounds - Control | Placebo comparator | Other: 0.9% Normal Saline - IrrigationThis arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline. |
| Acute Wounds - Experimental | Experimental | Drug: Micro/nanobubble (MNB) - IrrigationThis arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline. |
| Chronic Wounds - Control | Placebo comparator | Other: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline. |
| Chronic Wounds - Experimental | Experimental | Drug: Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are above the age of 18.
- 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.
Key exclusion criteria (3 listed)
- have infected wounds.
- have wounds with exposed vital structures such as nerves, arteries, and/or veins.
- have wounds associated with malignancy.
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 |
|---|---|---|
| Micro/nanobubble (MNB) - IrrigationAn 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. | Drug | Acute Wounds - Experimental |
| 0.9% Normal Saline - IrrigationA 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. | Other | Acute Wounds - Control |
| 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. | Drug | Chronic Wounds - Experimental |
| 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. | Other | Chronic Wounds - Control |
Primary outcome
Wound total oxygen saturation level
Time frame: 2-4 weeks
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxygenation saturation levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen saturation measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.
Wound Size/ Surface Area (cm^2)
Time frame: 2-4 weeks
Daily photographs taken before initiation of treatment and during treatment.
Analysis of wound pH
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups, and a pH strip will be used to measure the pH.
Wound oxyhemoglobin concentration level
Time frame: 2-4 weeks
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.
Wound deoxyhemoglobin concentration level
Time frame: 2-4 weeks
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound deoxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.
Analysis of wound GM-CSF concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GM-CSF concentration levels.
Analysis of wound interferon concentration levels
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interferon concentration levels: IFN alpha, IFN gamma. *These levels will be reported in the same units of measure.
Analysis of wound interleukin (IL) concentration levels
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interleukin concentration levels: IL-1 alpha, IL-1 beta, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A (CTLA-8), IL-18, IL-21, IL-22, IL-23, IL-27, IL-31. *These levels will be reported in the same units of measure.
Analysis of wound tumor necrosis factor (TNF) concentration levels
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following TNF concentration levels: TNF alpha, TNF beta. *These levels will be reported in the same units of measure.
Analysis of wound Eotaxin (CCL11) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess Eotaxin (CCL11) concentration levels.
Analysis of wound GRO alpha (CXCL1) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GRO alpha (CXCL1) concentration levels.
Analysis of wound IP-10 (CXCL10) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess IP-10 (CXCL10) concentration levels.
Analysis of wound MCP-1 (CCL2) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MCP-1 (CCL2) concentration levels.
Analysis of wound MIP-1 alpha (CCL3) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 alpha (CCL3) concentration levels.
Analysis of wound MIP-1 beta (CCL4) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 beta (CCL4) concentration levels.
Analysis of wound RANTES (CCL5) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess RANTES (CCL5) concentration levels.
Analysis of wound SDF-1 alpha concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess SDF-1 alpha concentration levels.
Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP1 concentration level.
Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP8 concentration level.
Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level
Time frame: 2-4 weeks
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP 13 concentration level.
3 secondary outcomes
Hospital Length of Stay (LOS)
Time frame: 2-4 weeks
Number of participants that return to the operating room
Time frame: 2-4 weeks
Number of participants readmitted to the hospital for same wound after discharge
Time frame: 4-8 weeks
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 2 Oct 2025.
- BackgroundTsuge H. Micro- and Nanobubbles: Fundamentals and Applications. Boca Raton: CRC Press; 2014.
- BackgroundMatiasek 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.
- Results publication: PubMed 29314626Sayadi 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.
- Results publication: PubMed 30200336Khan 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.
- Results publication: PubMed 27681204Lalezari 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.
- Results publication: PubMed 24251842Back 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.
- Results publication: PubMed 28118847Jarbrink 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers outside this study.
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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.
Raj Vyas, MD principal investigator
University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Micro/nanobubble (MNB) - Irrigation, 0.9% Normal Saline - Irrigation and Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi) in people with Open Wound and Wound Heal, run by University of California, Irvine at 1 site in United States.
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 6 inclusion and 3 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 2 Oct 2025. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Leonardo Alaniz, BBA (602-318-7118, alanizl1@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound total oxygen saturation level (time frame: 2-4 weeks). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169814, which also lists 7 linked publications.
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 2 Oct 2025.