Dehisced Surgical WoundsNCT01547325
Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds
A study testing NanoDOX 1% doxycycline monohydrate Hydrogel in people with Dehisced Surgical Wounds, run by NanoSHIFT LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dehisced Surgical Wounds
- What is being tested?
- NanoDOX 1% doxycycline monohydrate Hydrogel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: 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.
- Conditions
- Dehisced Surgical Wounds
- Being tested
- NanoDOX 1% doxycycline monohydrate Hydrogel, placebo hydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoDOX 1% doxycycline monohydrate HydrogelDrug
1% doxycycline monohydrate hydrogel
placebo hydrogelDrug
placebo hydrogel
| Study group | Role | What they receive |
|---|---|---|
| NanoDOX Hydrogel | Experimental | Not described Receives: Drug: NanoDOX 1% doxycycline monohydrate Hydrogel |
| Placebo Hydrogel | Placebo comparator | Not described Receives: Drug: placebo hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 100% wound closure during the 8-week study
Measured: subjects will be followed during their participation in the study for an average of 8 weeks
Secondary outcomes (1)
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
Measured: subjects will be followed during their participatoni in the study for an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehisced Surgical WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoSHIFT LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547325
- Sponsor's protocol ID
- 2008-DOX-NT/005
- Status last verified
- Mar 2017
- First submitted
- 24 Feb 2012
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Single-Site, Pilot Study of NanoDOX Hydrogel Versus Placebo Hydrogel for Dehisced Surgical Wounds.
- ClinicalTrials.gov ID
- NCT01547325
- Acronym / sponsor ID
- 2008-DOX-NT/005
- Conditions
- Dehisced Surgical Wounds
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NanoSHIFT LLCIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoDOX Hydrogel | Experimental | Drug: NanoDOX 1% doxycycline monohydrate Hydrogel |
| Placebo Hydrogel | Placebo comparator | Drug: placebo hydrogel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoDOX 1% doxycycline monohydrate Hydrogel1% doxycycline monohydrate hydrogel | Drug | NanoDOX Hydrogel |
| placebo hydrogelplacebo hydrogel | Drug | Placebo Hydrogel |
Primary outcome
The rate of 100% wound closure during the 8-week study
Time frame: subjects will be followed during their participation in the study for an average of 8 weeks
1 secondary outcome
Safety endpoint
Time frame: subjects will be followed during their participatoni in the study for an average of 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NanoDOX 1% doxycycline monohydrate Hydrogel in people with Dehisced Surgical Wounds, run by NanoSHIFT LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of 100% wound closure during the 8-week study (time frame: subjects will be followed during their participation in the study for an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.