Pilonidal Disease
Conditions
Keywords
ACell, ACell MicroMatrix®, ACell Cytal® Wound Matrix, Urinary Bladder Matrix
Brief summary
A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.
Detailed description
This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.
Interventions
DEVICEWound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix
Porcine-derived extracellular matrix will be used in powder and 2-Layer wound sheet form in masses up to 1000 mg. Each product is intended for a one-time use only.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has a clinical diagnosis of pilonidal disease. 2. Subject is being scheduled for surgical excision of pilonidal disease. 3. Subject is at least 18 years of age. 4. 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. 5. Subject is willing to provide written informed consent.
Exclusion criteria
1. Subject has a known allergy to porcine-based materials. 2. Subject is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Wound Closure | Up to 3 month visit | The study was terminated by Sponsor; no outcome measure data analyses were conducted. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for Pain | Up to 3 month visit | The study was terminated by Sponsor; no outcome measure data analyses were conducted. |
| Katz Index of Independence in Activities of Daily Living (KATZ ADL) | Up to 3 month visit | The study was terminated by Sponsor; no outcome measure data analyses were conducted. |
| Wound Related Adverse Events | Up to 3 month visit | Number and type of wound related adverse events as recorded on adverse event case report forms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Rate of Wound Closure
The study was terminated by Sponsor; no outcome measure data analyses were conducted.
Time frame: Up to 3 month visit
Population: Data was collected from the two participants in the study however, rate of wound closure was not analyzed due to an extremely small sample size and study termination by Sponsor.
Other Pre-specified
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
The study was terminated by Sponsor; no outcome measure data analyses were conducted.
Time frame: Up to 3 month visit
Population: The study was terminated by sponsor; no outcome measure data analyses were conducted. The Investigator was not able to achieve the enrollment goal to allow for data analyses.
Other Pre-specified
Visual Analogue Scale (VAS) for Pain
The study was terminated by Sponsor; no outcome measure data analyses were conducted.
Time frame: Up to 3 month visit
Population: The study was terminated by sponsor; no outcome measure data analyses were conducted. The Investigator was not able to achieve the enrollment goal to allow for data analyses.
Other Pre-specified
Wound Related Adverse Events
Number and type of wound related adverse events as recorded on adverse event case report forms
Time frame: Up to 3 month visit
Population: The study was terminated by sponsor; no outcome measure data analyses were conducted. The Investigator was not able to achieve the enrollment goal to allow for data analyses.