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

NCT ID: NCT01734109

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pressure Ulcers

Keywords

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Negative Pressure Wound Therapy Irrigation Therapy Pressure Ulcers Sacral Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care - Wound Care

Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Quantum NPWT

Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.

Group Type ACTIVE_COMPARATOR

Quantum Negative Pressure Wound Therapy Device

Intervention Type DEVICE

To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.

Quantum NPWT with Irrigation

NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.

Group Type ACTIVE_COMPARATOR

Quantum Negative Pressure Wound Therapy Device

Intervention Type DEVICE

To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.

Interventions

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Quantum Negative Pressure Wound Therapy Device

To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.

Intervention Type DEVICE

Other Intervention Names

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Quantum NPWT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra J Berriman, Ph.D.

Role: STUDY_DIRECTOR

Innovative Therapies, Inc.

Kenneth Moquin, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital System

Locations

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Henry Ford Hospital System

Detroit, Michigan, United States

Site Status

Countries

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United States

Central Contacts

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Kenneth Moquin, MD

Role: CONTACT

Phone: 734-301-1083

Email: [email protected]

Nadia Obeid, MD

Role: CONTACT

Phone: 248-709-0067

Email: [email protected]

Other Identifiers

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ITIQ002A

Identifier Type: -

Identifier Source: org_study_id