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.

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.

Study Overview

• Status: Unknown
• Conditions: Pressure Ulcers
• Intervention / Treatment: Device: Quantum Negative Pressure Wound Therapy Device

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kenneth Moquin, MD; Phone Number: 734-301-1083; Email: kmoquin1@hfhs.org
• Study Contact Backup: Name: Nadia Obeid, MD; Phone Number: 248-709-0067; Email: nobeid1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital System
      • Principal Investigator: Kenneth Moquin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Weekly assessment of pain using standard VAS.	12 weeks

Collaborators and Investigators

• Sponsor: Innovative Therapies, Inc.
• Investigators: Study Director: Sandra J Berriman, Ph.D., Innovative Therapies, Inc.; Principal Investigator: Kenneth Moquin, MD, Henry Ford Hospital System

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Estimate): November 28, 2012
• Last Update Submitted That Met QC Criteria: November 27, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Pressure Ulcers; Negative Pressure Wound Therapy; Irrigation Therapy; Sacral Ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: ITIQ002A