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This study has been withdrawn prior to enrollment.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
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
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 21, 2014