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Trial record 48 of 61 for:    Neomycin sulfate

Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care

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ClinicalTrials.gov Identifier: NCT02138994
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : March 28, 2017
Sponsor:
Collaborators:
Mayo Clinic
Jacksonville Center For Clinical Research
Information provided by (Responsible Party):
Next Science TM

Brief 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 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.

Condition or disease Intervention/treatment Phase
Wound Chronic Draining Device: Next Science Wound Gel Drug: Triple Antibiotic Ointment Neosporin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : September 2016

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Arm Intervention/treatment
Active Comparator: Triple Antibiotic Ointment Neosporin
Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.
Drug: Triple Antibiotic Ointment Neosporin

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

Experimental: Next Science Wound Gel
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.
Device: Next Science Wound Gel



Primary Outcome Measures :
  1. Wound Size Reduction [ Time Frame: 2, 4, 8 and 12 weeks ]

Secondary Outcome Measures :
  1. Wound Closure [ Time Frame: 2, 4, 8 and 12 weeks ]

Other Outcome Measures:
  1. Reduction of bacterial species types and amounts [ Time Frame: 0 and 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138994


Locations
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United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Jacksonville Center for Clinical Research - RCCR location
Jacksonville, Florida, United States, 32256
Sponsors and Collaborators
Next Science TM
Mayo Clinic
Jacksonville Center For Clinical Research

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Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT02138994     History of Changes
Other Study ID Numbers: CSP-001
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Neomycin
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Wounds and Injuries
Anti-Bacterial Agents
Bacitracin
Polymyxin B
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action