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

NCT01518491 | Withdrawn Phase 2

• 1 other identifier: 2009-DOX-NT/009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy.

  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.

  participants will be followed for up to eight weeks

Secondary Outcomes (1)

• Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds

  participants will have three visits per week for up to eight weeks

Study Arms (2)

NanoDOX Hydrogel plus VAC

EXPERIMENTAL

NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on open traumatic orthopedic and soft tissue wounds in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

Drug: NanoDOX Hydrogel

VAC Alone

ACTIVE COMPARATOR

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.

Other: VAC Alone

Interventions

NanoDOX Hydrogel DRUG

NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy

NanoDOX Hydrogel plus VAC

VAC Alone OTHER

Patients will receive VAC therapy three time weekly for eight weeks

VAC Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older
• Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline
• Agree to use a double-barrier method of contraception during their participation in this study
• condoms (with spermicide) and hormonal contraceptives OR
• condoms (with spermicide) and intrauterine device OR
• intrauterine device and hormonal contraceptives OR
• Abstains from sexual intercourse during their participation in this study
• Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
• Have a full-thickness trauma wound that is between 1.2cm2 and 24cm2 at initial screening
• Be able to apply study drug to their wound, or have a reliable and capable caregiver do it
• Subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (TcpO2) of \>30mmHg recorded over intact epidermis at the wound margin.

You may not qualify if:

• Less than 18 years of age
• Pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
• Allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
• Tested positive for a doxycycline-resistant infection
• Have undergone treatment with systemic corticosteroid or immunosuppressive therapy in the past 2 months
• Currently undergoing dialysis for renal failure
• Have participated in another clinical research trial within the last 30 days
• Subject has wounds resulting from any cause other than trauma (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult)
• Active or previous (within 60 days prior to the study screening visit) chemotherapy
• Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo
• Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits
• The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
• History of sickle cell anemia
• History of infection with Human Immunodeficiency Virus
• History of other immunodeficiency disorders

Sponsors & Collaborators

• NanoSHIFT LLC: lead
• United States Department of Defense: collaborator

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Univeristy of Missouri

Columbia, Missouri, 65212, United States

Location

Study Officials

• John Abernethy, MD

  Alachua Government Services, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 26, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

US (2)