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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Next Science TM
• Collaborators: Jacksonville Center For Clinical Research; Jacksonville Clinical Research Center; Mayo Clinic
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Bacitracin; Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination; Neomycin; Polymyxin B

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