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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Innovative Therapies, Inc.
Sponsor:
Information provided by (Responsible Party):
Innovative Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01734109
First received: November 21, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Pressure Ulcers
Device: Quantum Negative Pressure Wound Therapy Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Innovative Therapies, Inc.:

Primary Outcome Measures:
  • Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care [ Time Frame: 12-weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.


Other Outcome Measures:
  • Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Weekly assessment of pain using standard VAS.


Estimated Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Innovative Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01734109     History of Changes
Other Study ID Numbers: ITIQ002A
Study First Received: November 21, 2012
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014