Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

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

Official Title
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Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.

Conditions
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Dehisced Surgical Wounds

Intervention / Treatment
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* Drug: NanoDOX 1% doxycycline monohydrate Hydrogel
* Drug: placebo hydrogel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NanoDOX Hydrogel<br> | Drug: NanoDOX 1% doxycycline monohydrate Hydrogel<br>* 1% doxycycline monohydrate hydrogel<br>|
| Placebo Comparator: Placebo Hydrogel<br> | Drug: placebo hydrogel<br>* placebo hydrogel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |