Open Label Trial of NanoDOX Hydrogel in Orthopedic Trauma Wounds With and Without Vacuum Assisted Closure Therapy

NanoSHIFT

Status and phase: Withdrawn; Phase 2

Conditions: Orthopedic Trauma Wounds

Treatments: Drug: NanoDOX Hydrogel; Other: VAC Alone

Study type: Interventional

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

Identifiers

NCT01518491

2009-DOX-NT/009

Details and patient eligibility

About

The purpose of this study is to determine the effect of NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on the healing rates of open traumatic orthopedic and soft tissue wounds when compared to a serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

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

• 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

• 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 trauma wound that is between 1.2cm2 and 24cm2 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 wound margin.

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 systemic 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 trauma (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, including the shock wave treatment procedure, 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 < 7 g/dl (males) or < 6.5 (females)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

NanoDOX Hydrogel plus VAC

Experimental group

Description:

NanoDOX™ Hydrogel in conjunction with serial wound debridement and irrigation on open traumatic orthopedic and soft tissue wounds in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

Treatment:

Drug: NanoDOX Hydrogel

VAC Alone

Active Comparator group

Description:

Serial wound debridement and irrigation alone in patients receiving negative pressure wound therapy/vacuum assisted closure (NPWT/VAC) with reticulated open cell foam (ROCF) dressings.

Treatment:

Other: VAC Alone