RecruitingEarly Phase 1NCT05169814

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

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

Sponsor

University of California, Irvine

Enrollment

40 participants

Start Date

Oct 9, 2021

Study Type

INTERVENTIONAL

Conditions

Wound Heal Open Wound

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria3

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

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Interventions

DRUGMicro/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.

OTHER0.9% 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.

DRUGMicro/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.

OTHER0.9% 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.