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

Innovative Therapies, Inc.

Status and phase: Unknown; Phase 4

Conditions: Pressure Ulcers

Treatments: Device: Quantum Negative Pressure Wound Therapy Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01734109

ITIQ002A

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Standard of Care - Wound Care

Placebo Comparator group

Description:

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

Quantum NPWT

Active Comparator group

Description:

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

Treatment:

Device: Quantum Negative Pressure Wound Therapy Device

Quantum NPWT with Irrigation

Active Comparator group

Description:

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

Treatment:

Device: Quantum Negative Pressure Wound Therapy Device