Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01547325
First received: February 24, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.


Condition Intervention
Dehisced Surgical Wounds
Drug: NanoDOX 1% doxycycline monohydrate Hydrogel
Drug: placebo hydrogel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.

Resource links provided by NLM:


Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: May 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NanoDOX Hydrogel Drug: NanoDOX 1% doxycycline monohydrate Hydrogel
1% doxycycline monohydrate hydrogel
Placebo Comparator: Placebo Hydrogel Drug: placebo hydrogel
placebo hydrogel

  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, 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
  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: NCT01547325

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Nanotherapeutics, Inc.
  More Information

No publications provided

Responsible Party: Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01547325     History of Changes
Other Study ID Numbers: 2008-DOX-NT/005
Study First Received: February 24, 2012
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014