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MNB Therapy for Wound Healing (MNB Trial)

Phase < 1
Recruiting
Led By Raj Vyas, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with traumatic, surgical, or chronic wounds
Patients with acute ischemic wounds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-8 weeks
Awards & highlights

MNB Trial Summary

This trial will test whether MNBs are effective and safe for healing wounds.

Who is the study for?
This trial is for adults over 18 with various types of wounds, including traumatic, surgical, chronic wounds, pressure ulcers (like diabetic foot or venous ulcers), radiotherapy tissue injury, and burns. It's not for those with infected wounds, exposed vital structures like nerves or arteries in the wound area, or cancer-related wounds.Check my eligibility
What is being tested?
The study tests if Micro/nanobubbles (MNBs) can help heal acute and chronic wounds better than normal saline. Participants will receive either MNB irrigation alone or combined with Negative Pressure Wound Therapy compared to saline treatments.See study design
What are the potential side effects?
Potential side effects are not specified but may include skin irritation at the treatment site, allergic reactions to the solution used in MNBs or saline solutions during irrigation and therapy.

MNB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have wounds from an injury, surgery, or a long-term condition.
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I have fresh wounds caused by poor blood flow.
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I have injuries from burns (heat, chemicals, or electricity).
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I have skin ulcers due to pressure, diabetes, or poor blood flow.
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I have tissue damage from radiation therapy.

MNB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of wound Eotaxin (CCL11) concentration level
Analysis of wound GM-CSF concentration level
Analysis of wound GRO alpha (CXCL1) concentration level
+17 more
Secondary outcome measures
Hospital Length of Stay (LOS)
Number of participants readmitted to the hospital for same wound after discharge
Number of participants that return to the operating room

MNB Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Chronic Wounds - ExperimentalExperimental Treatment1 Intervention
This arm will include patients with chronic wounds and will receive experimental treatment: negative pressure wound therapy with instillation (NPWTi) using micro/nanobubbles (MNB's) in normal saline.
Group II: Acute Wounds - ExperimentalExperimental Treatment1 Intervention
This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline.
Group III: Acute Wounds - ControlPlacebo Group1 Intervention
This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.
Group IV: Chronic Wounds - ControlPlacebo Group1 Intervention
This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline.

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,003 Total Patients Enrolled
1 Trials studying Wound Healing
30 Patients Enrolled for Wound Healing
Raj Vyas, MDPrincipal InvestigatorUniversity of California, Irvine, Dept. of Plastic Surgery; Vice-Chairman

Media Library

Micro/nanobubble (MNB) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05169814 — Phase < 1
Wound Healing Research Study Groups: Acute Wounds - Control, Acute Wounds - Experimental, Chronic Wounds - Control, Chronic Wounds - Experimental
Wound Healing Clinical Trial 2023: Micro/nanobubble (MNB) Highlights & Side Effects. Trial Name: NCT05169814 — Phase < 1
Micro/nanobubble (MNB) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169814 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on participant enrollment for this clinical trial?

"Affirmative. According to details made available on clinicaltrials.gov, this medical research is still in the recruitment phase and was initially announced on October 9th 2021. The last update came on January 29th 2022 and 40 individuals are being sought at a single clinic."

Answered by AI

Are applications being accepted for this experiment at the present time?

"Affirmative, according to the data presented on clinicaltrials.gov, this medical experiment is currently recruiting patients. The trial was first posted on October 9th 2021 and amended as recently as January 29th 2022 - in search of 40 volunteers from a single site."

Answered by AI
Recent research and studies
~10 spots leftby Mar 2025