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

Conditions

Micro/nanobubble (MNB) - Irrigation — DRUG
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 — OTHER
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.

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.

Placebo Comparator: Acute Wounds - Control
This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.
Experimental: 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.
Placebo Comparator: 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.
Experimental: 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.

Wound total oxygen saturation level [ Time Frame: 2-4 weeks ]

Facility	City	State	ZIP	Site coordinators
UCI Medical Center	Orange	California	92868	Leonardo Alaniz, MD [email protected] 602-318-7118 Lohrasb R Sayadi, MD [email protected] (949) 209-7267

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