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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Другое 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.
• Препарат 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• Hospital Length of Stay (LOS) [Срок оценки: 2-4 weeks]
• Number of participants that return to the operating room [Срок оценки: 2-4 weeks]
• Number of participants readmitted to the hospital for same wound after discharge [Срок оценки: 4-8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UCI Medical Center — Orange

Публикации

• 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

Идентификаторы

NCT: NCT05169814 · 5901 · 154138

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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