Clinical trial NCT01547325: Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds
Official title: Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dehisced Surgical Wounds
Lead sponsor: NanoSHIFT LLC
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2012-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: The rate of 100% wound closure during the 8-week study
timeFrame: subjects will be followed during their participation in the study for an average of 8 weeks
Secondary outcomes:
measure: Safety endpoint
timeFrame: subjects will be followed during their participatoni in the study for an average of 8 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
References: