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.
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedNovember 28, 2012
November 1, 2012
9 months
November 21, 2012
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation
12 weeks
Other Outcomes (1)
Pain
12 weeks
Study Arms (3)
Standard of Care - Wound Care
PLACEBO COMPARATORStandard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement.
Quantum NPWT
ACTIVE COMPARATORIntervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.
Quantum NPWT with Irrigation
ACTIVE COMPARATORNPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.
Interventions
To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Clinical evidence of active, gross infection.
- Patient or patient's guardian refuses consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Hospital System
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandra J Berriman, Ph.D.
Innovative Therapies, Inc.
- PRINCIPAL INVESTIGATOR
Kenneth Moquin, MD
Henry Ford Hospital System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2012
First Posted
November 27, 2012
Study Start
December 1, 2012
Primary Completion
September 1, 2013
Study Completion
March 1, 2014
Last Updated
November 28, 2012
Record last verified: 2012-11