Orthopedic Trauma Wounds Clinical Trial
Official title:
A Prospective, Randomized, Open Label Trial of NanoDOX™ Hydrogel Plus Vacuum Assisted Closure Therapy Versus Vacuum Assisted Closure Therapy Alone in Orthopedic Trauma Wounds.
| Verified date | June 2017 |
| Source | NanoSHIFT LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| United States | Univeristy of Missouri | Columbia | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| NanoSHIFT LLC | United States Department of Defense |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the effect of NanoDOX Hydrogel on the healing rates of open traumatic orthopedic wounds with and without vacuum assisted closure therapy. | 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. | participants will be followed for up to eight weeks | |
| Secondary | Analyze the molecular changes in proinflammatory cytokine levels and bioburden that occur in traumatic orthopedic and soft tissue wounds | Analyze the molecular changes in proinflammatory cytokine levels and bioburden (quantitative bacteriology and qRT-PCR for 16S rDNA) that occur in traumatic orthopedic and soft tissue wounds as a function of healing rate in the presence/absence of NanoDOX™ Hydrogel. | participants will have three visits per week for up to eight weeks |