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

Plain Language Summary

Simplified for easier understanding

This study is testing whether tiny bubbles (micro/nanobubbles) dissolved in water can help heal wounds when used as a wash or soak. These special bubbles may increase oxygen delivery to damaged tissue and speed up healing, and researchers want to see how effective this is for different types of wounds. You may be eligible if: - You are 18 years or older - You have a traumatic, surgical, or chronic wound - You have a wound from radiation therapy - You have a burn injury (thermal, chemical, or electrical) - You have a pressure ulcer, diabetic foot ulcer, venous ulcer, arterial ulcer, or neuropathic skin ulcer - You have an acute ischemic wound You may NOT be eligible if: - Your wound is currently infected - Your wound exposes vital structures such as nerves, arteries, or veins - Your wound is associated with a malignancy (cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.