Cytal® Wound Matrix and MicroMatrix® Wound Study

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03632954
• Collaborator: Winthrop University Hospital (Other)
• Enrollment: 37
• Location: 1
• Actual Duration (Months): 13.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

Condition or Disease	Intervention/Treatment	Phase
Wounds	Device: ACell Arm

Detailed Description

A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds
• Actual Study Start Date: Dec 11, 2018
• Actual Primary Completion Date: Jan 27, 2020
• Actual Study Completion Date: Jan 27, 2020

Arms and Interventions

Arm

Intervention/Treatment

ACell Arm Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.

Device: ACell Arm; Cytal® Wound Matrix and/or MicroMatrix®

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Completely Healed Wounds [Up to 12 weeks]

   Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.

2. Wound Size Change [Up to 12 weeks]

   Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.

Secondary Outcome Measures

1. Time to Complete Wound Closure [up to 52 week visit (until study completion)]

   Determine time to complete wound closure using Silhouette Star camera system.

2. Wound Characteristics [up to 52 week visit (until study completion)]

   Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.

3. Incidence of Bridging [up to 52 week visit (until study completion)]

   Bridging to definitive closure or transition to cellular therapy

4. Visual Analogue Scale (VAS) for Pain [Up to 52 week visit (until study completion)]

   VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in mm with a higher score (100mm) indicating a greater pain intensity.

5. Wound Quality of Life (W-QOL) [Up to 52 week visit (until study completion)]

   W-QOL is a 17-item Likert style questionnaire that measures 3 subscales in a participant (Body, Psyche, and Everyday to then calculate an overall global score. An overall global score is obtained from averaging all items. Each item is coded with numbers 0 (not at all) to 4 (very much) with a higher score indicating a lower quality of life.

6. Katz Index of Independence in Activities of Daily Living (KATZ ADL) [Up to 52 week visit (until study completion)]

   The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment

7. Complete Wound Management [up to 52 week visit (until study completion)]

   Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.

8. Wound-Related Adverse Events [up to 52 week visit (until study completion)]

   Number and type of wound-related adverse events as recorded on adverse event case report forms.

Other Outcome Measures

1. Direct Product and Care Costs [up to 52 week visit (until study completion)]

   Measures the direct cost of products

2. Indirect Product and Care Costs [up to 52 week visit (until study completion)]

   Measures the total of the indirect and incidental costs

3. Return to Work Status [up to 52 week visit (until study completion)]

   Measures change in "return to work status" and/or "reported work status"

4. Cost Associated With AEs, UADEs and SAEs [up to 52 week visit (until study completion)]

   Measure frequency of wound specific events, capturing incident specific costs per event.

5. Wound Pathology [Up to 12 weeks]

   Measures the effect of treatment through quantitative analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.

2. Subject is at least 21 years of age.

3. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.

4. Subject or legal representative is willing to provide informed consent.

5. For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

Exclusion Criteria:

1. Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.

2. Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.

3. The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.

4. The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).

5. Wound with exposed organs or hardware.

6. Wound with burn etiology.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Winthrop Hospital	Long Island City	New York	United States	11501

Sponsors and Collaborators

• Integra LifeSciences Corporation
• Winthrop University Hospital

Investigators

• Study Chair: Allison Matthews, Integra LifeSciences Corporation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 18, 2019

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT03632954
• Other Study ID Numbers: CR2017-012
• First Posted: Aug 16, 2018
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Integra LifeSciences Corporation: Wounds; ACell; ACell MicroMatrix®; ACell Cytal® Wound Matrix; Extracellular Matrix; Urinary Bladder Matrix
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Period Title: Overall Study
STARTED	37
COMPLETED	3
NOT COMPLETED	34

Baseline Characteristics

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Overall Participants	37
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	22 59.5%
>=65 years	15 40.5%
Sex: Female, Male (Count of Participants)
Female	20 54.1%
Male	17 45.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 10.8%
Not Hispanic or Latino	33 89.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	12 32.4%
White	24 64.9%
More than one race	0 0%
Unknown or Not Reported	1 2.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Completely Healed Wounds
Description	Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

The study was terminated by Sponsor prior to completion, all enrolled subjects did not complete 12 weeks follow-up prior to termination.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	23
Count of Participants [Participants]	4 10.8%

2. Primary Outcome

Title	Wound Size Change
Description	Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

3. Secondary Outcome

Title	Time to Complete Wound Closure
Description	Determine time to complete wound closure using Silhouette Star camera system.
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

4. Secondary Outcome

Title	Wound Characteristics
Description	Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

5. Secondary Outcome

Title	Incidence of Bridging
Description	Bridging to definitive closure or transition to cellular therapy
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

6. Secondary Outcome

Title	Visual Analogue Scale (VAS) for Pain
Description	VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in mm with a higher score (100mm) indicating a greater pain intensity.
Time Frame	Up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

7. Secondary Outcome

Title	Wound Quality of Life (W-QOL)
Description	W-QOL is a 17-item Likert style questionnaire that measures 3 subscales in a participant (Body, Psyche, and Everyday to then calculate an overall global score. An overall global score is obtained from averaging all items. Each item is coded with numbers 0 (not at all) to 4 (very much) with a higher score indicating a lower quality of life.
Time Frame	Up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

8. Secondary Outcome

Title	Katz Index of Independence in Activities of Daily Living (KATZ ADL)
Description	The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment
Time Frame	Up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

9. Secondary Outcome

Title	Complete Wound Management
Description	Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

10. Secondary Outcome

Title	Wound-Related Adverse Events
Description	Number and type of wound-related adverse events as recorded on adverse event case report forms.
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

11. Other Pre-specified Outcome

Title	Direct Product and Care Costs
Description	Measures the direct cost of products
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

12. Other Pre-specified Outcome

Title	Indirect Product and Care Costs
Description	Measures the total of the indirect and incidental costs
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

13. Other Pre-specified Outcome

Title	Return to Work Status
Description	Measures change in "return to work status" and/or "reported work status"
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

14. Other Pre-specified Outcome

Title	Cost Associated With AEs, UADEs and SAEs
Description	Measure frequency of wound specific events, capturing incident specific costs per event.
Time Frame	up to 52 week visit (until study completion)

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

15. Other Pre-specified Outcome

Title	Wound Pathology
Description	Measures the effect of treatment through quantitative analysis
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Data was not collected and outcome measure analysis was not performed.

Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
Measure Participants	0

Adverse Events

Time Frame	52 weeks
Arm/Group Title	ACell Arm
Arm/Group Description	Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. ACell Arm: Cytal® Wound Matrix and/or MicroMatrix®
All Cause Mortality
	ACell Arm
	Affected / at Risk (%)	# Events
Total	1/37 (2.7%)
Serious Adverse Events
	ACell Arm
	Affected / at Risk (%)	# Events
Total	6/37 (16.2%)
General disorders
inpatient wound management	1/37 (2.7%)	1
Infections and infestations
abdominal pain/septic shock	1/37 (2.7%)	1
bacteremia	1/37 (2.7%)	1
discharge at device application site	1/37 (2.7%)	1
urinary tract infection/sepsis	1/37 (2.7%)	1
Musculoskeletal and connective tissue disorders
accidental fall	1/37 (2.7%)	1
Respiratory, thoracic and mediastinal disorders
shortness of breath/cough	1/37 (2.7%)	1
Surgical and medical procedures
scheduled surgery and hospitalization	1/37 (2.7%)	1
Other (Not Including Serious) Adverse Events
	ACell Arm
	Affected / at Risk (%)	# Events
Total	17/37 (45.9%)
Cardiac disorders
atrial fibrillation	1/37 (2.7%)	1
General disorders
bleeding at wound site	1/37 (2.7%)	1
hematoma at device application site	1/37 (2.7%)	1
increase in wound size	6/37 (16.2%)	7
inflammation at device application site	1/37 (2.7%)	1
malaise	1/37 (2.7%)	1
near syncope episode	1/37 (2.7%)	1
pain at application site, discharge at application site	1/37 (2.7%)	1
pain at device application site (excessive or exacerbated)	1/37 (2.7%)	1
Infections and infestations
cellulitis at device application site	1/37 (2.7%)	1
cellulitis, leg	1/37 (2.7%)	1
conjunctivitis	1/37 (2.7%)	1
osteomyelitis at device application site	1/37 (2.7%)	1
urinary tract infection	1/37 (2.7%)	2
Musculoskeletal and connective tissue disorders
wrist injury	1/37 (2.7%)	1
Respiratory, thoracic and mediastinal disorders
pneumonia	1/37 (2.7%)	1
Skin and subcutaneous tissue disorders
burning sensation	1/37 (2.7%)	1
facial rash	1/37 (2.7%)	1
rash	1/37 (2.7%)	1
seroma	3/37 (8.1%)	4
skin maceration	1/37 (2.7%)	1
small maculopapular rash (possible reaction to complex wound dressing)	1/37 (2.7%)	1
wound necrosis	2/37 (5.4%)	2

Limitations/Caveats

Due to early termination, additional primary, secondary, and tertiary endpoint analyses were not performed.

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.