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

NCT ID: NCT02138994

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Triple Antibiotic Ointment Neosporin

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Next Science Wound Gel

Intervention Type: DEVICE

Interventions

Next Science Wound Gel

Intervention Type: DEVICE

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Jacksonville Center For Clinical Research

OTHER

Sponsor Role: collaborator

Next Science TM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research - RCCR location

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

CSP-001

Identifier Type: -

Identifier Source: org_study_id