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

Wound Chronic Draining Clinical Trial

Official title:

Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138994
• Other study ID #: CSP-001
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: March 27, 2017
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Next Science TM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Chronic Draining
• Wounds and Injuries

Intervention

Device:
• Next Science Wound Gel

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

Locations

Country	Name	City	State
United States	Jacksonville Center for Clinical Research - RCCR location	Jacksonville	Florida
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Next Science TM	Jacksonville Clinical Research Center, Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduction of bacterial species types and amounts		0 and 4 weeks
Primary	Wound Size Reduction		2, 4, 8 and 12 weeks
Secondary	Wound Closure		2, 4, 8 and 12 weeks