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

NCT02246608 | Completed Results

• 1 other identifier: KHN-RSWound-P14-N01
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Wound Abdominal Wall; Wound Non Healing

Outcome Measures

Primary Outcomes (1)

• Closure Rate of Non-healing Wounds

  Wound dimensions will be measured weekly and monitored for changes

  12 weeks

Secondary Outcomes (1)

• Growth Factors

  12 weeks

Study Arms (2)

Routine NPWT Standard of Care

ACTIVE COMPARATOR

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

NPWT Standard of Care plus Oasis wound product

EXPERIMENTAL

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

Interventions

NPWT Standard of Care plus Oasis wound product DEVICE

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.

NPWT Standard of Care plus Oasis wound product

Routine NPWT Standard of Care DEVICE

Specialized material, often foam, designed to protect the wound and promote healing during NPWT.

Routine NPWT Standard of Care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues.
• Patients with Infected wounds.

Sponsors & Collaborators

• Kettering Health Network: lead

Study Sites (1)

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Results Point of Contact

• Title: Manager, Research Operation and Regulatory Compliance
• Organization: Kettering Health Network

innovationcenter@ketteringhealth.org

937-395-8367

Study Officials

• Richard Simman, MD

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 23, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: January 1, 2018
• Last Updated: September 27, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)