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

Sponsor

University of California, Irvine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05169814

Collaborator

(none)

Enrollment

Location

Arms

14.7

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Open Wound Wound Heal	Drug: Micro/nanobubble (MNB) - Irrigation Other: 0.9% Normal Saline - Irrigation Drug: Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi) Other: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi)	Early Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a pilot study that consists of 4 arms: Acute wounds: 1 control arm; 1 experimental arm (treated with MNB irrigation) Chronic wounds: 1 control arm; 1 experimental arm (treated with Negative pressure wound therapy with MNB instillation)This is a pilot study that consists of 4 arms:Acute wounds: 1 control arm; 1 experimental arm (treated with MNB irrigation) Chronic wounds: 1 control arm; 1 experimental arm (treated with Negative pressure wound therapy with MNB instillation)

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

This is a double-blind, controlled study. Participants will be selected and matched based on similar wound profiles, pathology mechanisms, comorbidity profiles, and age. They will randomly be assigned to the experimental (MNB) or control (normal saline) group. The randomization ratio between both groups will be 1:1. Measurements of objective datapoints (e.g. StO2), cytokines, proteases, and pH will be taken by blinded research personnel.

Primary Purpose:

Treatment

Official Title:

Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds

Actual Study Start Date :

Oct 9, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Acute Wounds - Control This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.	Other: 0.9% 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.
Experimental: Acute Wounds - Experimental This arm will include patients with acute wounds and will receive experimental treatment: irrigation with micro/nanobubbles (MNB's) in normal saline.	Drug: Micro/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.
Placebo Comparator: Chronic Wounds - Control This arm will include patients with chronic wounds and will receive standard of care: negative pressure wound therapy with instillation (NPWTi) using normal saline.	Other: 0.9% 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.
Experimental: Chronic Wounds - Experimental 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.	Drug: Micro/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.

Outcome Measures

Primary Outcome Measures

Wound total oxygen saturation level [2-4 weeks]
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.
Wound Size/ Surface Area (cm^2) [2-4 weeks]
Daily photographs taken before initiation of treatment and during treatment.
Analysis of wound pH [2-4 weeks]
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.
Wound oxyhemoglobin concentration level [2-4 weeks]
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.
Wound deoxyhemoglobin concentration level [2-4 weeks]
Near Infrared Spectroscopy Imaging (NIRS) (KENT SnapShot https://www.kentimaging.com/product/) will be used to assess wound deoxyhemoglobin 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.
Analysis of wound GM-CSF concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GM-CSF concentration levels.
Analysis of wound interferon concentration levels [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interferon concentration levels: IFN alpha, IFN gamma. *These levels will be reported in the same units of measure.
Analysis of wound interleukin (IL) concentration levels [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following interleukin concentration levels: IL-1 alpha, IL-1 beta, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 (CXCL8), IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A (CTLA-8), IL-18, IL-21, IL-22, IL-23, IL-27, IL-31. *These levels will be reported in the same units of measure.
Analysis of wound tumor necrosis factor (TNF) concentration levels [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess the following TNF concentration levels: TNF alpha, TNF beta. *These levels will be reported in the same units of measure.
Analysis of wound Eotaxin (CCL11) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess Eotaxin (CCL11) concentration levels.
Analysis of wound GRO alpha (CXCL1) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess GRO alpha (CXCL1) concentration levels.
Analysis of wound IP-10 (CXCL10) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess IP-10 (CXCL10) concentration levels.
Analysis of wound MCP-1 (CCL2) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MCP-1 (CCL2) concentration levels.
Analysis of wound MIP-1 alpha (CCL3) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 alpha (CCL3) concentration levels.
Analysis of wound MIP-1 beta (CCL4) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MIP-1 beta (CCL4) concentration levels.
Analysis of wound RANTES (CCL5) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess RANTES (CCL5) concentration levels.
Analysis of wound SDF-1 alpha concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess SDF-1 alpha concentration levels.
Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP1 concentration level.
Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP8 concentration level.
Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level [2-4 weeks]
With each dressing change, a non-traumatic vidal curette will be used to collect wound exudate in both groups. The proteins will then be extracted by standard methods, and ELISA kits will be used to assess MMP 13 concentration level.

Secondary Outcome Measures

Hospital Length of Stay (LOS) [2-4 weeks]
Days of hospital admission
Number of participants that return to the operating room [2-4 weeks]
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.
Number of participants readmitted to the hospital for same wound after discharge [4-8 weeks]
Qualifying individuals include participants that are readmitted to the hospital for the same wound that was treated by the study investigators.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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