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Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

This study is not yet open for participant recruitment.
Verified April 2012 by Nanotherapeutics, Inc.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01547325
First received: February 24, 2012
Last updated: April 25, 2012
Last verified: April 2012
History of Changes

February 24, 2012
April 25, 2012
May 2012
October 2012   (final data collection date for primary outcome measure)
The rate of 100% wound closure during the 8-week study [ Time Frame: subjects will be followed during their participation in the study for an average of 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01547325 on ClinicalTrials.gov Archive Site
Safety endpoint [ Time Frame: subjects will be followed during their participatoni in the study for an average of 8 weeks ] [ Designated as safety issue: Yes ]
determined by wound score, area of the wound, and the assessment of wound effluent cytokine, chemokine, protease, and patient reported pain and quality of life questionnaires
Same as current
Not Provided
Not Provided
 
Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds
Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.

The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dehisced Surgical Wounds
  • Drug: NanoDOX 1% doxycycline monohydrate Hydrogel
    1% doxycycline monohydrate hydrogel
  • Drug: placebo hydrogel
    placebo hydrogel
  • Experimental: NanoDOX Hydrogel
    Intervention: Drug: NanoDOX 1% doxycycline monohydrate Hydrogel
  • Placebo Comparator: Placebo Hydrogel
    Intervention: Drug: placebo hydrogel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
Not Provided
October 2012   (final data collection date for primary outcome measure)

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, and:

  • 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 OR
    • 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 dehisced surgical wound that is between 1.2cm2 and 4 cm2 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 dehisced surgical wound margin
  • Non-infected (Quantitative bacterial count of < 1.0 x 105 cfu)

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 system 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 surgical intervention (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 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 < 10 g/dL (males) or < 9 g/dL (females)
  • Severe malnutrition (Albumin < 3.0 gm/dl; > 10% weight loss in preceding 6 weeks)
  • Subjects that the Investigators deems unstable and/or require intensive monitoring
Both
18 Years and older
No
Contact: John Aberenthy, MD 386-462-9663 ext 326 jabernethy@nanotherapeutics.com
Contact: Angie Kimbler, CCRP 386-462-9663 ext 313 akimbler@nanotherapeutics.com
United States
 
NCT01547325
2008-DOX-NT/005
No
Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
Department of Defense
Not Provided
Nanotherapeutics, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP