Clinical trial NCT05169814: Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds
Official title: Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Open Wound
Wound Heal
Keywords: acute wounds
chronic wounds
MNB solution
MNB
Micro/nanobubbles
Micronanobubbles
negative pressure wound therapy with instillation
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* have infected wounds.
* have wounds with exposed vital structures such as nerves, arteries, and/or veins.
* have wounds associated with malignancy.

Primary outcomes:
measure: Wound total oxygen saturation level
timeFrame: 2-4 weeks
measure: Wound Size/ Surface Area (cm^2)
timeFrame: 2-4 weeks
measure: Analysis of wound pH
timeFrame: 2-4 weeks
measure: Wound oxyhemoglobin concentration level
timeFrame: 2-4 weeks
measure: Wound deoxyhemoglobin concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound GM-CSF concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound interferon concentration levels
timeFrame: 2-4 weeks
measure: Analysis of wound interleukin (IL) concentration levels
timeFrame: 2-4 weeks
measure: Analysis of wound tumor necrosis factor (TNF) concentration levels
timeFrame: 2-4 weeks
measure: Analysis of wound Eotaxin (CCL11) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound GRO alpha (CXCL1) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound IP-10 (CXCL10) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound MCP-1 (CCL2) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound MIP-1 alpha (CCL3) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound MIP-1 beta (CCL4) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound RANTES (CCL5) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound SDF-1 alpha concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level
timeFrame: 2-4 weeks
measure: Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level
timeFrame: 2-4 weeks
Secondary outcomes:
measure: Hospital Length of Stay (LOS)
timeFrame: 2-4 weeks
measure: Number of participants that return to the operating room
timeFrame: 2-4 weeks
measure: Number of participants readmitted to the hospital for same wound after discharge
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Medical Center
state: California
Study officials:
affiliation: University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman
name: Raj Vyas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsuge H. Micro- and Nanobubbles: Fundamentals and Applications. Boca Raton: CRC Press; 2014.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.