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

NCT01518491 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-06-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • NanoSHIFT LLC

    lead INDUSTRY

Principal Investigators

  • John Abernethy, MD · Alachua Government Services, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518491 on ClinicalTrials.gov