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

Not Applicable

Completed

• Conditions: Open Wound Abdominal Wall; Wound Non Healing
• Interventions: Device: Routine NPWT Standard of Care; Device: NPWT Standard of Care plus Oasis wound product

• Registration Number: NCT02246608
• Lead Sponsor: Kettering Health Network

Brief 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.

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-23
• Primary Completion: 2017-04
• Study Completion: 2018-01
• Results First Submitted: 2018-02-06
• Results First Submitted QC: 2018-07-23
• Status Verified: 2018-08
• Results First Posted: 2018-08-21
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine NPWT Standard of Care	Routine NPWT Standard of Care	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, standard of care dressing will be placed.
NPWT Standard of Care plus Oasis wound product	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.

Primary Outcome Measures

Name	Time	Method
Closure Rate of Non-healing Wounds	12 weeks	Wound dimensions will be measured weekly and monitored for changes

Secondary Outcome Measures

Name	Time	Method
Growth Factors	12 weeks	Fluid collected from the wound will be examined for the presence of growth factors and interleukins.

Trial Locations

Locations (1)

Kettering Medical Center; 🇺🇸 Kettering, Ohio, United States