Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID05169814

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

Led by University of California, Irvine · Updated on 2025-10-02

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of micro/nanobubbles (MNBs) to improve healing in both acute and chronic wounds. The study focuses on how increasing oxygen delivery to wounds using MNBs might enhance the natural healing process. This early phase research aims to provide new insights into wound care by comparing standard treatments with MNB-enhanced methods. Participants with acute wounds will receive either normal saline irrigation or irrigation with MNBs in saline gauze applied daily. Those with chronic wounds will be treated using negative pressure wound therapy with instillation (NPWTi), where either normal saline or MNBs in saline are continuously applied with dressing changes every 3 to 5 days. These treatments follow current standard wound care practices, with the addition of MNBs as the experimental intervention. Participants will be involved for about 2 to 4 weeks or for the duration of their hospital stay if shorter. Wound characteristics and measurements will be taken before and after treatment. Researchers will monitor tissue oxygenation using infrared technology and collect various wound healing measurements, including oxygen saturation, wound size, pH, and levels of specific proteins and markers related to healing. Safety and healing progress will be closely observed, with data analyzed to understand the impact of MNB treatment on wound recovery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 18 years of age or older
  • Have traumatic, surgical, or chronic wounds
  • Have radiotherapy related tissue injury
  • Have thermal, chemical, or electrical burn injuries
  • Have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, or neuropathic skin ulcers
  • Have acute ischemic wounds
Not Eligible

You will not qualify if you...

  • Have infected wounds
  • Have wounds with exposed vital structures such as nerves, arteries, or veins
  • Have wounds associated with malignancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 to 4 weeks or duration of inpatient admission

Participants receive daily wound treatment with micro/nanobubbles (MNBs) in saline gauze for acute wounds or continuous MNB negative pressure wound therapy with instillation (NPWTi) for chronic wounds, with wound evaluations and dressing changes every 3-5 days.

Daily dressing changes for acute wounds; dressing changes every 3-5 days for chronic wounds with regular wound evaluations

Trial Site Locations

Total: 1 location

1

UCI Medical Center

Orange, California, United States, 92868

Actively Recruiting

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Research Team

L

Leonardo Alaniz, BBA

L

Lohrasb R Sayadi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Oxygen-Carrying Micro/Nanobubbles: Composition, Synthesis Techniques and Potential Prospects in Photo-Triggered Theranostics.

Muhammad Saad Khan, Jangsun Hwang, Kyungwoo Lee...

https://pubmed.ncbi.nlm.nih.gov/30200336

Recommendations on negative pressure wound therapy with instillation and antimicrobial solutions - when, where and how to use: what does the evidence show?

David A Back, Catharina Scheuermann-Poley, Christian Willy

https://pubmed.ncbi.nlm.nih.gov/24251842