Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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

• 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

• 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 trauma wound that is between 1.2cm2 and 24cm2 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 wound margin.

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 systemic 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 trauma (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, including the shock wave treatment procedure, 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 < 7 g/dl (males) or < 6.5 (females)