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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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

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Open Wound Abdominal Wall Wound Non Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Routine NPWT Standard of Care

Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.

Group Type ACTIVE_COMPARATOR

Routine NPWT Standard of Care

Intervention Type DEVICE

Specialized material, often foam, designed to protect the wound and promote healing during NPWT.

NPWT Standard of Care plus Oasis wound product

Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied in addition to standard of care dressing.

Group Type EXPERIMENTAL

NPWT Standard of Care plus Oasis wound product

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Routine NPWT Standard of Care

Specialized material, often foam, designed to protect the wound and promote healing during NPWT.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No