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

NCT02246608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-09-27

Study results available
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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.

Conditions

  • Open Wound Abdominal Wall
  • Wound Non Healing

Interventions

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.

Sponsors & Collaborators

  • Kettering Health Network

    lead OTHER

Principal Investigators

  • Richard Simman, MD · Kettering Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-04-30
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246608 on ClinicalTrials.gov