Wound Chronic DrainingNCT02138994
Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
A study testing Next Science Wound Gel and Triple Antibiotic Ointment Neosporin in people with Wound Chronic Draining, run by Next Science TM at 2 sites in United States.
Trial summary
This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Chronic Draining
- What is being tested?
- Next Science Wound Gel and Triple Antibiotic Ointment Neosporin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Sep 2016
- 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
- Male or female 18 years or older
- Presence of full-thickness wound for more than one month (i.e. chronic)
- Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
- NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
- Willing to comply with all study procedures and be available for the duration of the study
- Provide signed and dated informed consent
Who cannot join
- Subjects unable to provide signed and dated informed consent
- Male or female less than 18 years old
- Presence of a full-thickness wound for less than one month
- A candidate for vascular reconstructive surgery to restore blood flow to the wound
- Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
- Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
- Subject with known allergic reaction to the study products
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Florida
Jacksonville, Florida, 32224
Jacksonville Center for Clinical Research - RCCR location
Jacksonville, Florida, 32256
About this study
Official title: Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.
- Conditions
- Wound Chronic Draining
- Being tested
- Next Science Wound Gel, Triple Antibiotic Ointment Neosporin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Science Wound GelDevice
Triple Antibiotic Ointment NeosporinDrug
Subjects randomized to Neosporin will be required to complete 1 month of treatment comprising a screening/baseline, 2-week and 1-month visits. After 1 month the following may occur based on wound progression and/or the investigator's clinical judgment:
- Subject may continue the application of Neosporin until wound closure or
- Subject may cross over to the treatment group for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Triple Antibiotic Ointment Neosporin | Active comparator | Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider. Receives: Drug: Triple Antibiotic Ointment Neosporin |
| Next Science Wound Gel | Experimental | Daily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider. Receives: Device: Next Science Wound Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Size Reduction
Measured: 2, 4, 8 and 12 weeks
Secondary outcomes (1)
Wound Closure
Measured: 2, 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Chronic DrainingStudies 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
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Jacksonville Center For Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138994
- Sponsor's protocol ID
- CSP-001
- Status last verified
- Mar 2017
- First submitted
- 12 May 2014
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
- ClinicalTrials.gov ID
- NCT02138994
- Acronym / sponsor ID
- CSP-001
- Conditions
- Wound Chronic Draining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic, Jacksonville Center For Clinical Research
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 May 2014 (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.
This is a 3 to 4 months, multi-site, prospective randomized clinical study of patients diagnosed with a chronic wound. The primary objective is to assess changes in healing rate, by measuring differences in wound area when treating chronic wounds with the Next Science Wound Gel compared to the Triple Antibiotic Ointment Neosporin (Standard of Care, SOC). At the end of the study period, patients may continue receiving their assigned study treatment provided they have signed the "Continuation of Treatment Informed Consent" and the rational for continuation is documented by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Antibiotic Ointment Neosporin | Active comparator | Drug: Triple Antibiotic Ointment NeosporinDaily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider. |
| Next Science Wound Gel | Experimental | Device: Next Science Wound GelDaily direct application to the wound, covered with a conventional non-alginate dressing. Dressing should be changed daily or as directed by the health care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female 18 years or older
- Presence of full-thickness wound for more than one month (i.e. chronic)
- Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
- NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (7 listed)
- Subjects unable to provide signed and dated informed consent
- Male or female less than 18 years old
- Presence of a full-thickness wound for less than one month
- A candidate for vascular reconstructive surgery to restore blood flow to the wound
- Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
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 |
|---|---|---|
| Next Science Wound Gel | Device | Next Science Wound Gel |
| Triple Antibiotic Ointment NeosporinSubjects randomized to Neosporin will be required to complete 1 month of treatment comprising a screening/baseline, 2-week and 1-month visits. After 1 month the following may occur based on wound progression and/or the investigator's clinical judgment: * Subject may continue the application of Neosporin until wound closure or * Subject may cross over to the treatment group for 3 months | Drug | Triple Antibiotic Ointment Neosporin |
Primary outcome
Wound Size Reduction
Time frame: 2, 4, 8 and 12 weeks
1 secondary outcome
Wound Closure
Time frame: 2, 4, 8 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Next Science Wound Gel and Triple Antibiotic Ointment Neosporin in people with Wound Chronic Draining, run by Next Science TM at 2 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 28 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 2 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wound Size Reduction (time frame: 2, 4, 8 and 12 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 28 Mar 2017.