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

Open Wound Abdominal Wall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246608
• Other study ID #: KHN-RSWound-P14-N01
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Open Wound Abdominal Wall
• Wound Non Healing
• Wounds and Injuries

Intervention

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.
• Routine NPWT Standard of Care
Specialized material, often foam, designed to protect the wound and promote healing during NPWT.

Locations

Country	Name	City	State
United States	Kettering Medical Center	Kettering	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kettering Health Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure Rate of Non-healing Wounds	Wound dimensions will be measured weekly and monitored for changes	12 weeks
Secondary	Growth Factors	Fluid collected from the wound will be examined for the presence of growth factors and interleukins.	12 weeks