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

Phase 4

• Conditions: Pressure Ulcers
• Interventions: Device: Quantum Negative Pressure Wound Therapy Device

• Registration Number: NCT01734109
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28
• Study Start: 2012-12
• Primary Completion: 2013-09
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quantum NPWT	Quantum Negative Pressure Wound Therapy Device	Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.
Quantum NPWT with Irrigation	Quantum Negative Pressure Wound Therapy Device	NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.

Primary Outcome Measures

Name	Time	Method
Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care	12-weeks	Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.

Secondary Outcome Measures

Name	Time	Method
Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation	12 weeks	Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.

Trial Locations

Locations (1)

Henry Ford Hospital System; 🇺🇸 Detroit, Michigan, United States