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Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and promotes granulation tissue and angiogenesis. Despite these known means for facilitation of wound management, further research is needed to examine whether this modality is superior to other currently used options, thus defining clear indications for and benefits of NPWT. This would also help establish the role of combination therapy, using NPWT with simultaneous irrigation or other forms of dressings. This study aims to compare treatment efficacy of NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is comparison of reduction of wound volume between the three treatment arms; and secondary endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care - Wound Care | Placebo Comparator | Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement. | |
| Quantum NPWT | Active Comparator | Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks. |
|
| Quantum NPWT with Irrigation | Active Comparator | NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantum Negative Pressure Wound Therapy Device | Device | To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care | Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation | Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Weekly assessment of pain using standard VAS. | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Moquin, MD | Contact | 734-301-1083 | kmoquin1@hfhs.org | |
| Nadia Obeid, MD | Contact | 248-709-0067 | nobeid1@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Sandra J Berriman, Ph.D. | Innovative Therapies, Inc. | Study Director |
| Kenneth Moquin, MD | Henry Ford Hospital System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital System | Detroit | Michigan | 48202 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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