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Use of a motorized waterjet to debride wounds to improve healing outcomes.
Hydroprep is a powered waterjet of saline solution used to debride, remove and surgically clean an open wound of any type to improve its ability to heal. The device may also be used to prepare a wound prior to application of a tissue product or a skin graft from the patient. Between treatments, the use of a negative pressure suction portable unit will be used to improve the healing outcome of the wound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Other | Hydroprep and Negative pressure therapy arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motion NPWT | Device | Negative Pressure application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Area Reduction of Wound Size | PAR reduction | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| "Graft Ready State" | Time to achieve target wound to a Graft-ready status | Within 28 days |
| Number of Negative Pressure Dressing Applications | Actual number of times the NPWT dressing was changed prior to discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric J Lullove, DPM | West Boca Center for Wound Healing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Boca Center for Wound Healing | Coconut Creek | Florida | 33073 | United States |
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| Label | URL |
|---|---|
| MedAxis, LLC | View source |
| MIMOSA Oxygen Thermography Device | View source |
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Demographic only: gender, age, race, medical problems, medications and study related treatments and measurements.
At conclusion of study.
Only the PI and Site investigator(s) and affiliated Study-related persons cleared to view materials.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 20, 2026 |
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| 28 days |
| Feb 20, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014947 | Wounds and Injuries |
| D000072836 | Surgical Wound |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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