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

Pressure Ulcers Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01734109
• Other study ID #: ITIQ002A
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 21, 2012
• Last updated: November 27, 2012
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2012
• Source: Innovative Therapies, Inc.
• Contact: Kenneth Moquin, MD
• Phone: 734-301-1083
• Email: kmoquin1[@]hfhs.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Device:
• Quantum Negative Pressure Wound Therapy Device
To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.

Locations

Country	Name	City	State
United States	Henry Ford Hospital System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain	Weekly assessment of pain using standard VAS.	12 weeks	No
Primary	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	Yes
Secondary	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	Yes