Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

NanoSHIFT

Status: Withdrawn

Conditions: Dehisced Surgical Wounds

Treatments: Drug: NanoDOX 1% doxycycline monohydrate Hydrogel; Drug: placebo hydrogel

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01547325

2008-DOX-NT/005

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

NanoDOX Hydrogel

Experimental group

Treatment:

Drug: NanoDOX 1% doxycycline monohydrate Hydrogel

Placebo Hydrogel

Placebo Comparator group

Treatment:

Drug: placebo hydrogel