Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds
- Conditions
- Dehisced Surgical Wounds
- Interventions
- Drug: placebo hydrogel
- Registration Number
- NCT01547325
- Lead Sponsor
- NanoSHIFT LLC
- Brief Summary
The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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Be 18 years of age or older
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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
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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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Hydrogel placebo hydrogel - NanoDOX Hydrogel NanoDOX 1% doxycycline monohydrate Hydrogel -
- Primary Outcome Measures
Name Time Method The rate of 100% wound closure during the 8-week study subjects will be followed during their participation in the study for an average of 8 weeks
- Secondary Outcome Measures
Name Time Method Safety endpoint subjects will be followed during their participatoni in the study for an average of 8 weeks 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
Trial Locations
- Locations (1)
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States