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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
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.
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.
UCI Medical Center
Orange, California, United States
RECRUITINGWound 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
Wound Size/ Surface Area (cm^2)
Daily photographs taken before initiation of treatment and during treatment.
Time frame: 2-4 weeks
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
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
Wound deoxyhemoglobin concentration level
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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.
Time frame: 2-4 weeks
Analysis of wound GM-CSF concentration level
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.
Time frame: 2-4 weeks
Analysis of wound interferon concentration levels
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.
Time frame: 2-4 weeks
Analysis of wound interleukin (IL) concentration levels
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.
Time frame: 2-4 weeks
Analysis of wound tumor necrosis factor (TNF) concentration levels
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.
Time frame: 2-4 weeks
Analysis of wound Eotaxin (CCL11) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound GRO alpha (CXCL1) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound IP-10 (CXCL10) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound MCP-1 (CCL2) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound MIP-1 alpha (CCL3) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound MIP-1 beta (CCL4) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound RANTES (CCL5) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound SDF-1 alpha concentration level
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.
Time frame: 2-4 weeks
Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level
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.
Time frame: 2-4 weeks
Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level
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.
Time frame: 2-4 weeks
Hospital Length of Stay (LOS)
Days of hospital admission
Time frame: 2-4 weeks
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
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