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

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ClinicalTrials.gov Identifier: NCT02246608
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : August 21, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Open Wound Abdominal Wall Wound Non Healing Device: NPWT Standard of Care plus Oasis wound product Device: Routine NPWT Standard of Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy (NPWT)
Actual Study Start Date : August 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Closure Rate of Non-healing Wounds [ Time Frame: 12 weeks ]
    Wound dimensions will be measured weekly and monitored for changes


Secondary Outcome Measures :
  1. Growth Factors [ Time Frame: 12 weeks ]
    Fluid collected from the wound will be examined for the presence of growth factors and interleukins.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246608


Locations
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United States, Ohio
Kettering Medical Center
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Kettering Health Network
Investigators
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Principal Investigator: Richard Simman, MD Kettering Health Network
  Study Documents (Full-Text)

Documents provided by Kettering Health Network:

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Responsible Party: Kettering Health Network
ClinicalTrials.gov Identifier: NCT02246608     History of Changes
Other Study ID Numbers: KHN-RSWound-P14-N01
First Posted: September 23, 2014    Key Record Dates
Results First Posted: August 21, 2018
Last Update Posted: September 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Wounds and Injuries