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

Kettering Health Network

Status: Completed

Conditions: Open Wound Abdominal Wall; Wound Non Healing

Treatments: Device: Routine NPWT Standard of Care; Device: NPWT Standard of Care plus Oasis wound product

Study type: Interventional

Funder types: Other

Identifiers

NCT02246608

KHN-RSWound-P14-N01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Routine NPWT Standard of Care

Active Comparator group

Description:

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

Treatment:

Device: Routine NPWT Standard of Care

NPWT Standard of Care plus Oasis wound product

Experimental group

Description:

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.

Treatment:

Device: NPWT Standard of Care plus Oasis wound product