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Clinical trial

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

ID
Name
20216555
Description
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.
Trial arms
Trial start
2021-10-09
Estimated PCD
2025-06-01
Trial end
2025-06-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Acute Wounds - Experimental
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.
Arms:
Acute Wounds - Control
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.
Arms:
Chronic Wounds - Experimental
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.
Arms:
Chronic Wounds - Control
Size
40
Primary endpoint
Wound total oxygen saturation level
2-4 weeks
Wound Size/ Surface Area (cm^2)
2-4 weeks
Analysis of wound pH
2-4 weeks
Wound oxyhemoglobin concentration level
2-4 weeks
Wound deoxyhemoglobin concentration level
2-4 weeks
Analysis of wound GM-CSF concentration level
2-4 weeks
Analysis of wound interferon concentration levels
2-4 weeks
Analysis of wound interleukin (IL) concentration levels
2-4 weeks
Analysis of wound tumor necrosis factor (TNF) concentration levels
2-4 weeks
Analysis of wound Eotaxin (CCL11) concentration level
2-4 weeks
Analysis of wound GRO alpha (CXCL1) concentration level
2-4 weeks
Analysis of wound IP-10 (CXCL10) concentration level
2-4 weeks
Analysis of wound MCP-1 (CCL2) concentration level
2-4 weeks
Analysis of wound MIP-1 alpha (CCL3) concentration level
2-4 weeks
Analysis of wound MIP-1 beta (CCL4) concentration level
2-4 weeks
Analysis of wound RANTES (CCL5) concentration level
2-4 weeks
Analysis of wound SDF-1 alpha concentration level
2-4 weeks
Analysis of wound matrix metalloproteinase 1 (MMP1) concentration level
2-4 weeks
Analysis of wound matrix metalloproteinase 8 (MMP8) concentration level
2-4 weeks
Analysis of wound matrix metalloproteinase 13 (MMP13) concentration level
2-4 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pilot study that consists of 4 arms:\n\n* Acute wounds: 1 control arm; 1 experimental arm (treated with MNB irrigation)\n* Chronic wounds: 1 control arm; 1 experimental arm (treated with Negative pressure wound therapy with MNB instillation)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

2 products

2 indications

Organization
University of California, Irvine
Product
Micro/nanobubble (MNB)
Indication
Wound
Indication
Wound Healing
Product
Micro/nanobubble