Back to resultsEfficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
Primary Purpose
Pressure Ulcers
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Quantum Negative Pressure Wound Therapy Device
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers focused on measuring Negative Pressure Wound Therapy, Irrigation Therapy, Pressure Ulcers, Sacral Ulcers
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.
Sites / Locations
- Henry Ford Hospital System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Standard of Care - Wound Care
Quantum NPWT
Quantum NPWT with Irrigation
Arm Description
Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement.
Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.
NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01734109
First Posted
November 21, 2012
Last Updated
November 27, 2012
Sponsor
Innovative Therapies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01734109
Brief Title
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovative Therapies, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Negative Pressure Wound Therapy, Irrigation Therapy, Pressure Ulcers, Sacral Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care - Wound Care
Arm Type
Placebo Comparator
Arm Description
Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement.
Arm Title
Quantum NPWT
Arm Type
Active Comparator
Arm Description
Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.
Arm Title
Quantum NPWT with Irrigation
Arm Type
Active Comparator
Arm Description
NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.
Intervention Type
Device
Intervention Name(s)
Quantum Negative Pressure Wound Therapy Device
Other Intervention Name(s)
Quantum NPWT
Intervention Description
To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.
Primary Outcome Measure Information:
Title
Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
Description
Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation
Description
Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Pain
Description
Weekly assessment of pain using standard VAS.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Moquin, MD
Phone
734-301-1083
Email
kmoquin1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Obeid, MD
Phone
248-709-0067
Email
nobeid1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra J Berriman, Ph.D.
Organizational Affiliation
Innovative Therapies, Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth Moquin, MD
Organizational Affiliation
Henry Ford Hospital System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Moquin, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.
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