Dehisced Surgical Wounds Clinical Trial
Official title:
Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.
| Verified date | March 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 effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2013 |
| 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, 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| NanoSHIFT LLC | United States Department of Defense |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Safety endpoint | 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 | subjects will be followed during their participatoni in the study for an average of 8 weeks |