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Recruiting NCT05169814

Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds

Early Phase I Interventional Open Wound Wound Heal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Open Wound, Wound Heal. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds

Overview

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.

Interventions

  • Drug 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.
  • Other 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.
  • Drug 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.
  • Other 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.

Primary outcome measures

  • Wound total oxygen saturation level [Time frame: 2-4 weeks]
  • Wound Size/ Surface Area (cm^2) [Time frame: 2-4 weeks]
  • Analysis of wound pH [Time frame: 2-4 weeks]
  • Wound oxyhemoglobin concentration level [Time frame: 2-4 weeks]
  • Wound deoxyhemoglobin concentration level [Time frame: 2-4 weeks]
  • Analysis of wound GM-CSF concentration level [Time frame: 2-4 weeks]
  • Analysis of wound interferon concentration levels [Time frame: 2-4 weeks]
  • Analysis of wound interleukin (IL) concentration levels [Time frame: 2-4 weeks]
  • Analysis of wound tumor necrosis factor (TNF) concentration levels [Time frame: 2-4 weeks]
  • Analysis of wound Eotaxin (CCL11) concentration level [Time frame: 2-4 weeks]
Secondary outcome measures (3)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCI Medical Center — Orange

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. PMID 29314626
  • 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. PMID 30200336
  • 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. PMID 27681204
  • 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. PMID 24251842
  • 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. PMID 28118847

Identifiers

NCT: NCT05169814 · 5901 · 154138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗