Micro/Nanobubbles (MNBs) and Wound Therapy: A Pilot Study Involving a Novel Oxygen Delivery System for Treatment of Acute and Chronic Wounds
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wound Size/ Surface Area (cm^2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are above the age of
- •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
排除标准
- •have infected wounds.
- •have wounds with exposed vital structures such as nerves, arteries, and/or veins.
- •have wounds associated with malignancy.
研究组 & 干预措施
Acute Wounds - Control
This arm will include patients with acute wounds and will receive standard of care: irrigation with normal saline.
干预措施: 0.9% Normal Saline - Irrigation (Other)
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.
干预措施: Micro/nanobubble (MNB) - Irrigation (Drug)
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.
干预措施: 0.9% Normal Saline - Negative Pressure Wound Therapy with Instillation (NPWTi) (Other)
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.
干预措施: Micro/nanobubble (MNB) - Negative Pressure Wound Therapy with Instillation (NPWTi) (Drug)
结局指标
主要结局
Wound Size/ Surface Area (cm^2)
时间窗: 2-4 weeks
Daily photographs taken before initiation of treatment and during treatment.
Analysis of wound GM-CSF concentration level
时间窗: 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 MIP-1 alpha (CCL3) concentration level
时间窗: 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.
Wound total oxygen saturation level
时间窗: 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.
Analysis of wound MIP-1 beta (CCL4) concentration level
时间窗: 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
时间窗: 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 pH
时间窗: 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
时间窗: 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.
Analysis of wound interferon concentration levels
时间窗: 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
时间窗: 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 Eotaxin (CCL11) concentration level
时间窗: 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 MCP-1 (CCL2) concentration level
时间窗: 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 SDF-1 alpha concentration level
时间窗: 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.
Wound deoxyhemoglobin concentration level
时间窗: 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 GRO alpha (CXCL1) concentration level
时间窗: 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 matrix metalloproteinase 13 (MMP13) concentration level
时间窗: 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.
Analysis of wound tumor necrosis factor (TNF) concentration levels
时间窗: 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 IP-10 (CXCL10) concentration level
时间窗: 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 matrix metalloproteinase 8 (MMP8) concentration level
时间窗: 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 1 (MMP1) concentration level
时间窗: 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.
次要结局
- Number of participants readmitted to the hospital for same wound after discharge(4-8 weeks)
- Hospital Length of Stay (LOS)(2-4 weeks)
- Number of participants that return to the operating room(2-4 weeks)
研究者
Raj Vyas
Lead Investigator
University of California, Irvine