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

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.

Study Overview

• Status: Completed
• Conditions: Wound Chronic Draining
• Intervention / Treatment: Drug: Triple Antibiotic Ointment Neosporin; Device: Next Science Wound Gel

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
    • Jacksonville, Florida, United States, 32256
      • Jacksonville Center for Clinical Research - RCCR location

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound Size Reduction	2, 4, 8 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Wound Closure	2, 4, 8 and 12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Reduction of bacterial species types and amounts	0 and 4 weeks

Collaborators and Investigators

• Sponsor: Next Science TM
• Collaborators: Mayo Clinic; Jacksonville Center For Clinical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
• Other Study ID Numbers: CSP-001