Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds
University of California, Irvine
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.
Description
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 patien…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * have infected wounds. * have wounds with exposed vital structures such as nerves, arteries, and/or veins. * have wounds associated with malignancy.
Interventions
- DrugMicro/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.
- Other0.9% 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.
- DrugMicro/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.
- Other0.9% 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.
Location
- UCI Medical CenterOrange, California