NCT02246608

Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy

Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Kettering Health Network · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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, along with standard of care including NPWT OR 2. Standard foam, applied to the wound prior to activation of NPWT, which is standard care. 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.

Conditions

• Open Wound Abdominal Wall
• Wound Non Healing

Interventions

Type	Name	Description
DEVICE	NPWT Standard of Care plus Oasis wound product	Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.
DEVICE	Routine NPWT Standard of Care	Specialized material, often foam, designed to protect the wound and promote healing during NPWT.

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-04-01
• Completion: 2018-01-01
• First posted: 2014-09-23
• Last updated: 2018-09-27
• Results posted: 2018-08-21

Locations

1 site across 1 country: United States