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RECRUITING
NCT05169814
EARLY_PHASE1

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-10-09

Completion Date

2027-06-01

Last Updated

2025-10-02

Healthy Volunteers

No

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.

Locations (1)

UCI Medical Center

Orange, California, United States