Health TrialsbyHealthPanel

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

ConditionsOpen WoundWound Heal
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

have infected wounds.

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

have wounds associated with malignancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Micro/nanobubble (MNB) - Irrigation

    Drug

    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.

  • 0.9% Normal Saline - Irrigation

    Other intervention

    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.

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

    Drug

    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.

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

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Acute Wounds - ControlPlacebo comparator 1 intervention
Group B: Acute Wounds - ExperimentalExperimental treatment 1 intervention
Group C: Chronic Wounds - ControlPlacebo comparator 1 intervention
Group D: Chronic Wounds - ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Wound total oxygen saturation level

Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxygenation saturation levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen saturation measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.

Time frame
2-4 weeks
2

Wound Size/ Surface Area (cm^2)

Daily photographs taken before initiation of treatment and during treatment.

Time frame
2-4 weeks
3

Analysis of wound pH

With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups, and a pH strip will be used to measure the pH.

Time frame
2-4 weeks
4

Wound oxyhemoglobin concentration level

Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound oxyhemoglobin concentration levels prior to the MNB or normal saline application. This will provide the investigators with a baseline oxygen tension measurement. The NIRS KENT SnapShot is an FDA approved non-contact-based imaging modality used to assess wound/tissue oxygenation in the clinical setting and is currently available in the investigators' research laboratory.

Time frame
2-4 weeks

Secondary outcomes

1

Hospital Length of Stay (LOS)

Days of hospital admission

Time frame
2-4 weeks
2

Number of participants that return to the operating room

Qualifying individuals include participants that return to the operating room for a procedure (e.g. surgical debridement) on the same wound being treated by the study investigators.

Time frame
2-4 weeks
3

Number of participants readmitted to the hospital for same wound after discharge

Qualifying individuals include participants that are readmitted to the hospital for the same wound that was treated by the study investigators.

Time frame
4-8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov
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