Kettering, Ohio 45429


Purpose:

This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.


Study summary:

In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either: 1. Oasis® matrix, applied to the wound, OR 2. Standard foam, applied to the wound prior to activation of NPWT. Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis. The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.


Criteria:

Inclusion Criteria: - Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection. - HbA1C < 8 (if patient is diabetic) - Adequate nutrition including albumin above 2.0 and prealbumin above 15. Exclusion Criteria: - Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues. - Patients with Infected wounds.


NCT ID:

NCT02246608


Primary Contact:

Principal Investigator
Richard Simman, MD
Kettering Health Network

Mary Connolly, PhD
Phone: 937-395-8390
Email: Mary.Connolly@ketteringhealth.org


Backup Contact:

Email: gordon.simmons@ketteringhealth.org
Gordon Simmons, BS
Phone: 937-395-8390


Location Contact:

Kettering, Ohio 45429
United States

Mary Connolly, PhD
Phone: 937-395-8390
Email: Mary.Connolly@ketteringhealth.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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