Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.

A 12-week, Single Site, Randomized Controlled Trial to Compare the Efficacy of Quantum NPWT With and Without Simultaneous Irrigation Versus Standard of Care on Reduction of the Volume of Stage III/IV Pressure Ulcers.

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.

Inclusion Criteria:

• Male or Female between the ages of 18 and 70
• Any patient with a stage III/IV pressure ulcer of the size large enough to indicate use of Negative Pressure Treatment.

Exclusion Criteria:

• Clinical evidence of active, gross infection.
• Patient or patient's guardian refuses consent.