Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

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

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

Study Overview

• Status: Withdrawn
• Conditions: Dehisced Surgical Wounds
• Intervention / Treatment: Drug: NanoDOX 1% doxycycline monohydrate Hydrogel; Drug: placebo hydrogel

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NanoDOX Hydrogel	Drug: NanoDOX 1% doxycycline monohydrate Hydrogel; 1% doxycycline monohydrate hydrogel
Placebo Comparator: Placebo Hydrogel	Drug: placebo hydrogel; placebo hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NanoSHIFT LLC
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: 2008-DOX-NT/005