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)

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 Overview

• Status: Completed
• Conditions: Open Wound Abdominal Wall; Wound Non Healing
• Intervention / Treatment: Device: Routine NPWT Standard of Care; Device: NPWT Standard of Care plus Oasis wound product

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine NPWT Standard of Care; Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.	Device: Routine NPWT Standard of Care; Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Closure Rate of Non-healing Wounds	Wound dimensions will be measured weekly and monitored for changes	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth Factors	Fluid collected from the wound will be examined for the presence of growth factors and interleukins.	12 weeks

Collaborators and Investigators

• Sponsor: Kettering Health Network
• Investigators: Principal Investigator: Richard Simman, MD, Kettering Health Network

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: KHN-RSWound-P14-N01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No