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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01734109

Enrollment

Registered

2012-11-27

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2012-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

Keywords

Negative Pressure Wound Therapy, Irrigation Therapy, Pressure Ulcers, Sacral Ulcers

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.

Interventions

DEVICEQuantum Negative Pressure Wound Therapy Device

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

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

Countries

United States

Contacts

Primary ContactKenneth Moquin, MD

kmoquin1@hfhs.org734-301-1083

Backup ContactNadia Obeid, MD

nobeid1@hfhs.org248-709-0067

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026