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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01518491
First received: January 18, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Orthopedic Trauma Wounds
Drug: NanoDOX Hydrogel
Other: VAC Alone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open Label Trial of NanoDOX™ Hydrogel Plus Vacuum Assisted Closure Therapy Versus Vacuum Assisted Closure Therapy Alone in Orthopedic Trauma Wounds.

Resource links provided by NLM:


Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:
  • Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy. [ Time Frame: participants will be followed for up to eight weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds [ Time Frame: participants will have three visits per week for up to eight weeks ] [ Designated as safety issue: Yes ]
    Analyze the molecular changes in proinflammatory cytokine levels and bioburden (quantitative bacteriology and qRT-PCR for 16S rDNA) that occur in traumatic orthopedic and soft tissue wounds as a function of healing rate in the presence/absence of NanoDOX™ Hydrogel.


Enrollment: 0
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NanoDOX Hydrogel plus VAC
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
NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy
Active Comparator: VAC Alone
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
Patients will receive VAC therapy three time weekly for eight weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518491

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Missouri
Univeristy of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
Nanotherapeutics, Inc.
Investigators
Study Director: John Abernethy, MD Nanotherapeutics, Inc.
  More Information

No publications provided

Responsible Party: Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01518491     History of Changes
Other Study ID Numbers: 2009-DOX-NT/009
Study First Received: January 18, 2012
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014