NCT01518491

Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy

A Prospective, Randomized, Open Label Trial of NanoDOX™ Hydrogel Plus Vacuum Assisted Closure Therapy Versus Vacuum Assisted Closure Therapy Alone in Orthopedic Trauma Wounds.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NanoSHIFT LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

Conditions

• Orthopedic Trauma Wounds

Interventions

Type	Name	Description
DRUG	NanoDOX Hydrogel	NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy
OTHER	VAC Alone	Patients will receive VAC therapy three time weekly for eight weeks

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-01-26
• Last updated: 2017-06-23

Locations

2 sites across 1 country: United States