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

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/29/2017
Start Date:	July 2014
End Date:	September 2016

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

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.

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

We found this trial at

sites

Mayo Clinic Florida

4500 San Pablo Rd S
Jacksonville, Florida 32224

(904) 953-2000