Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Raj Vyas, MD

Description

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

Details

Oxygen delivery is one of the primary factors in wound healing. Micro/nanobubbles (MNBs) can be used to increase the oxygen dissolved in solution and increase oxygen delivery to a wound. The purpose of this research study is to determine if MNBs applied to a wound improve wound healing. After being informed about the study and potential risks, all patients will need to provide written informed consent before being included in the study. The characteristics of the wound will be assessed and measurements will be taken before and after treatment. Depending on the patient's wound type, the patient will be treated with MNBs in saline gauze which will be applied to the wound daily (for acute wounds), or MNBs in negative pressure wound therapy with instillation (NPWTi) (for chronic wounds) which will be applied to the wound continuously throughout the day with the wound evaluated and sponge replaced every 3-5 days. This is consistent with the current standard of wound care with gauze or NPWTi. Tissue oxygenation using infrared technology and wound healing will be measured and results collected for analysis. Participation will last approximately 2-4 weeks or the duration of the inpatient admission. If discharge from the hospital is earlier than 2 weeks, the treatment will be discontinued and results will be submitted for analysis.

Keywords

Open Wound Wound Heal acute wounds chronic wounds MNB solution MNB Micro/nanobubbles Micronanobubbles negative pressure wound therapy with instillation Wounds and Injuries Micro/nanobubble (MNB) - Irrigation 0.9% Normal Saline - Irrigation Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi) 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)

Eligibility

You can join if…

Open to people ages 18 years and up

  • are above the age of 18.
  • have traumatic, surgical, or chronic wounds.
  • have radiotherapy related tissue injury.
  • have thermal, chemical, and/or electrical burn injuries.
  • have pressure ulcers, diabetic foot ulcers, venous ulcers, arterial ulcers, and/or neuropathic skin ulcers.
  • have acute ischemic wounds

You CAN'T join if...

  • have infected wounds.
  • have wounds with exposed vital structures such as nerves, arteries, and/or veins.
  • have wounds associated with malignancy.

Location

  • UCI Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Raj Vyas, MD
    Health Sciences Professor, Plastic Surgery, School of Medicine. Authored (or co-authored) 34 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05169814
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated