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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Device: Quantum Negative Pressure Wound Therapy Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard of Care - Wound Care<br>Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement. | |
| Active Comparator: Quantum NPWT<br>Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks. | Device: Quantum Negative Pressure Wound Therapy Device<br>* To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.<br>* Other names: Quantum NPWT;|
| Active Comparator: Quantum NPWT with Irrigation<br>NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid. | Device: Quantum Negative Pressure Wound Therapy Device<br>* To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.<br>* Other names: Quantum NPWT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Negative Pressure Wound Therapy, Irrigation Therapy, Pressure Ulcers, Sacral Ulcers