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

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ClinicalTrials.gov Identifier: NCT01734109
Recruitment Status : Unknown
Verified November 2012 by Innovative Therapies, Inc..
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2012
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Innovative Therapies, Inc.

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcers Device: Quantum Negative Pressure Wound Therapy Device Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care [ Time Frame: 12-weeks ]
    Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.


Secondary Outcome Measures :
  1. Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation [ Time Frame: 12 weeks ]
    Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.


Other Outcome Measures:
  1. Pain [ Time Frame: 12 weeks ]
    Weekly assessment of pain using standard VAS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734109


Contacts
Contact: Kenneth Moquin, MD 734-301-1083 kmoquin1@hfhs.org
Contact: Nadia Obeid, MD 248-709-0067 nobeid1@hfhs.org

Locations
United States, Michigan
Henry Ford Hospital System Not yet recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Kenneth Moquin, MD         
Sponsors and Collaborators
Innovative Therapies, Inc.
Investigators
Study Director: Sandra J Berriman, Ph.D. Innovative Therapies, Inc.
Principal Investigator: Kenneth Moquin, MD Henry Ford Hospital System

Responsible Party: Innovative Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01734109     History of Changes
Other Study ID Numbers: ITIQ002A
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Innovative Therapies, Inc.:
Negative Pressure Wound Therapy
Irrigation Therapy
Pressure Ulcers
Sacral Ulcers

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases