Overview

This trial is active, not recruiting.

Condition wound chronic draining
Treatments next science wound gel, triple antibiotic ointment neosporin
Sponsor Next Science TM
Collaborator Mayo Clinic
Start date July 2014
End date March 2016
Trial size 43 participants
Trial identifier NCT02138994, CSP-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.
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
(Experimental)
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.
next science wound gel

Primary Outcomes

Measure
Wound Size Reduction
time frame: 2, 4, 8 and 12 weeks

Secondary Outcomes

Measure
Wound Closure
time frame: 2, 4, 8 and 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Next Science TM.