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

University of California Irvine (UCI)

Status and phase: Enrolling; Early Phase 1

Conditions: Open Wound; Wound Heal

Treatments: Other: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi); Drug: Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi); Drug: Micro/nanobubble (MNB) - Irrigation; Other: 0.9% Normal Saline - Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05169814

154138 (Other Identifier)

5901

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Acute Wounds - Control

Placebo Comparator group

Description:

This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.

Treatment:

Other: 0.9% Normal Saline - Irrigation

Acute Wounds - Experimental

Experimental group

Description:

This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline.

Treatment:

Drug: Micro/nanobubble (MNB) - Irrigation

Chronic Wounds - Control

Placebo Comparator group

Description:

This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline.

Treatment:

Other: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)

Chronic Wounds - Experimental

Experimental group

Description:

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.

Treatment:

Drug: Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi)