NCT02138994

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Next Science TM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-03-01
• Completion: 2016-09-01
• First posted: 2014-05-15
• Last updated: 2017-03-28

Locations

2 sites across 1 country: United States