Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

NCT01547325 | Withdrawn

• 1 other identifier: 2008-DOX-NT/005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety endpoint

  subjects will be followed during their participatoni in the study for an average of 8 weeks

Study Arms (2)

NanoDOX Hydrogel

EXPERIMENTAL

Drug: NanoDOX 1% doxycycline monohydrate Hydrogel

Placebo Hydrogel

PLACEBO COMPARATOR

Drug: placebo hydrogel

Interventions

NanoDOX 1% doxycycline monohydrate Hydrogel DRUG

1% doxycycline monohydrate hydrogel

NanoDOX Hydrogel

placebo hydrogel DRUG

placebo hydrogel

Placebo Hydrogel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NanoSHIFT LLC: lead
• United States Department of Defense: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: March 7, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (1)