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

Next Science

Status: Completed

Conditions: Wound Chronic Draining

Treatments: Device: Next Science Wound Gel; Drug: Triple Antibiotic Ointment Neosporin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02138994

CSP-001

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Triple Antibiotic Ointment Neosporin

Active Comparator group

Description:

Daily direct application to the wound, covered with conventional dressing. Dressing should be changed daily or as directed by the health care provider.

Treatment:

Drug: Triple Antibiotic Ointment Neosporin

Next Science Wound Gel

Experimental group

Description:

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.

Treatment:

Device: Next Science Wound Gel