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

NCT05169814 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

  • Open Wound
  • Wound Heal

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.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Raj Vyas, MD · University of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-09
Primary Completion
2026-06-01
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05169814 on ClinicalTrials.gov