Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

• Status: Withdrawn
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NanoSHIFT LLC; Nanotherapeutics, Inc.
• Collaborator: United States Department of Defense
• Treatments: Doxycycline

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