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

NCT02138994 | Completed

• 1 other identifier: CSP-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Wound Chronic Draining

Outcome Measures

Primary Outcomes (1)

• Wound Size Reduction

  2, 4, 8 and 12 weeks

Secondary Outcomes (1)

• Wound Closure

  2, 4, 8 and 12 weeks

Other Outcomes (1)

• Reduction of bacterial species types and amounts

  0 and 4 weeks

Study Arms (2)

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.

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.

Device: Next Science Wound Gel

Interventions

Next Science Wound Gel DEVICE

Next Science Wound Gel

Triple Antibiotic Ointment Neosporin DRUG

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

Triple Antibiotic Ointment Neosporin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Next Science TM: lead
• Mayo Clinic: collaborator
• Jacksonville Center For Clinical Research: collaborator

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Jacksonville Center for Clinical Research - RCCR location

Jacksonville, Florida, 32256, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 15, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (2)