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

• Sponsor: Kettering Health Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT02246608
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 41
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Aug 1, 2014
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Closure Rate of Non-healing Wounds [12 weeks]

   Wound dimensions will be measured weekly and monitored for changes

Secondary Outcome Measures

1. Growth Factors [12 weeks]

   Fluid collected from the wound will be examined for the presence of growth factors and interleukins.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kettering Medical Center	Kettering	Ohio	United States	45429

Sponsors and Collaborators

• Kettering Health Network

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 30, 2015

More Information

Publications

None provided.

• Responsible Party: Kettering Health Network
• ClinicalTrials.gov Identifier: NCT02246608
• Other Study ID Numbers: KHN-RSWound-P14-N01
• First Posted: Sep 23, 2014
• Last Update Posted: Sep 27, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	NPWT Standard of Care	NPWT Standard of Care Plus Oasis Wound Product
Arm/Group Description	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT 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.
Period Title: Overall Study
STARTED	22	21
COMPLETED	10	11
NOT COMPLETED	12	10

Baseline Characteristics

Arm/Group Title	NPWT Standard of Care	NPWT Standard of Care Plus Oasis Wound Product	Total
Arm/Group Description	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT 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.	Total of all reporting groups
Overall Participants	10	11	21
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 60%	7 63.6%	13 61.9%
>=65 years	4 40%	4 36.4%	8 38.1%
Sex: Female, Male (Count of Participants)
Female	5 50%	5 45.5%	10 47.6%
Male	5 50%	6 54.5%	11 52.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 10%	0 0%	1 4.8%
White	9 90%	11 100%	20 95.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NPWT Standard of Care	NPWT Standard of Care Plus Oasis Wound Product
Arm/Group Description	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT 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.
Measure Participants	10	11
Mean (Standard Deviation) [percentage of healing]	45.79 (38.72)	89.98 (9.47)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements.

Arm/Group Title	NPWT Standard of Care	NPWT Standard of Care Plus Oasis Wound Product
Arm/Group Description	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT 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.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were collected from time of consent to completion of 12 week study visit.
Adverse Event Reporting Description	The events and effects noted as documented Risks will not be reported unless the event carries a level of severity that is unexpected. Hospitalization due to subject co-morbidities unrelated to Wound Treatment in this at-risk population will not be considered an SAE.
Arm/Group Title	NPWT Standard of Care		NPWT Standard of Care Plus Oasis Wound Product
Arm/Group Description	Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, foam wound product will be applied. Routine NPWT plus foam wound product: Specialized material, often foam, designed to protect the wound and promote healing during NPWT.		Prior to applying and activating the Negative Pressure Wound Treatment (NPWT) pump, Oasis wound product will be applied. Routine NPWT 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.
All Cause Mortality
	NPWT Standard of Care		NPWT Standard of Care Plus Oasis Wound Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Serious Adverse Events
	NPWT Standard of Care		NPWT Standard of Care Plus Oasis Wound Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/10 (20%)		1/11 (9.1%)
Renal and urinary disorders
Abdominal pain	1/10 (10%)	1	0/11 (0%)	0
Vascular disorders
Gangrene	0/10 (0%)	0	1/11 (9.1%)	1
Septic shock	1/10 (10%)	1	0/11 (0%)	0
Other (Not Including Serious) Adverse Events
	NPWT Standard of Care		NPWT Standard of Care Plus Oasis Wound Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.