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

Not Applicable

Completed

• Conditions: Wound Chronic Draining
• Interventions: Drug: Triple Antibiotic Ointment Neosporin; Device: Next Science Wound Gel

• Registration Number: NCT02138994
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Study Start: 2014-07
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triple Antibiotic Ointment Neosporin	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.
Next Science Wound Gel	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.

Primary Outcome Measures

Name	Time	Method
Wound Size Reduction	2, 4, 8 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Wound Closure	2, 4, 8 and 12 weeks

Trial Locations

Locations (2)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Jacksonville Center for Clinical Research - RCCR location; 🇺🇸 Jacksonville, Florida, United States