Next Science Wound Gel Efficacy in Chronic Wound Versus Standard of Care
Information source: Next Science TM
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Wound Chronic Draining
Intervention: Next Science Wound Gel (Device); Triple Antibiotic Ointment Neosporin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Next Science TM Overall contact:
Valerie Hayes, PhD, Phone: 904-864-7579, Email: vhayes.phd@gmail.com
Summary
This is a 3 to 4 months, single 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).
Clinical Details
Official title: Clinical Assessment of the Next Science Wound Gel Efficacy in Chronic Wound Compared to Standard of Care
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Wound Size Reduction
Secondary outcome: Wound Closure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Valerie Hayes, PhD, Phone: 904-864-7579, Email: vhayes.phd@gmail.com
Mayo Clinic Florida, Jacksonville, Florida 32224, United States; Recruiting
Mauricia Buchanan, RN, Phone: 904-953-2255, Email: Buchanan.Mauricia@mayo.edu
Albert Hakaim, MD, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: December 16, 2014
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