Chronic Lower Leg Ulcer, Diabetic Lower Extremity Ulcers, Pressure Injuries, Surgical Wounds, Traumatic Wounds and Injuries
Conditions
Keywords
Chronic Wounds, Debridement, Negative Pressure Wound Therapy, NPWT, Acute Wounds, Diabetic Ulcers, Venous Ulcers, Wounds
Brief summary
Use of a motorized waterjet to debride wounds to improve healing outcomes.
Detailed description
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.
Interventions
DEVICEMotion NPWT
Negative Pressure application
Sponsors
West Boca Center for Wound Healing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any chronic lower extremity wound greater than 30 days duration.
Exclusion criteria
* Active infection or previous tissue grafting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Area Reduction of Wound Size | 28 days | PAR reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| "Graft Ready State" | Within 28 days | Time to achieve target wound to a Graft-ready status |
| Number of Negative Pressure Dressing Applications | 28 days | Actual number of times the NPWT dressing was changed prior to discontinuation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric J Lullove, DPM
West Boca Center for Wound Healing
Outcome results
None listed