Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

NCT ID: NCT01547325

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-08-31

Brief Summary

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

Conditions

Dehisced Surgical Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NanoDOX Hydrogel

Group Type: EXPERIMENTAL

NanoDOX 1% doxycycline monohydrate Hydrogel

Intervention Type: DRUG

1% doxycycline monohydrate hydrogel

Placebo Hydrogel

Group Type: PLACEBO_COMPARATOR

placebo hydrogel

Intervention Type: DRUG

placebo hydrogel

Interventions

NanoDOX 1% doxycycline monohydrate Hydrogel

1% doxycycline monohydrate hydrogel

Intervention Type: DRUG

placebo hydrogel

placebo hydrogel

Intervention Type: DRUG

Eligibility 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, 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

NanoSHIFT LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

2008-DOX-NT/005

Identifier Type: -

Identifier Source: org_study_id