Trial Outcomes & Findings for The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series (NCT NCT04041037)

NCT ID: NCT04041037

Last Updated: 2021-04-20

Results Overview

The study was terminated by Sponsor; no outcome measure data analyses were conducted.

• Recruitment status: TERMINATED
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to 3 month visit
• Results posted on: 2021-04-20

Participant Flow

Participant milestones

Measure	All Participants Participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series

Baseline characteristics by cohort

Measure	All Participants n=2 Participants All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to Negative Pressure Wound Therapy on their pilonidal wounds.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

The study was terminated by Sponsor; no outcome measure data analyses were conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

The study was terminated by Sponsor; no outcome measure data analyses were conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

The study was terminated by Sponsor; no outcome measure data analyses were conducted.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=2 participants at risk All participants received MicroMatrix and Cytal Wound Matrix 2-layer in addition to standard of care Negative Pressure Wound Therapy on their pilonidal wounds.
Infections and infestations Bacterial Infection	50.0% 1/2 • Number of events 1 • 5 months

Additional Information

Allison Matthews

Integra LifeSciences

Phone: 443-766-3869

Email: allison.matthews@integralife.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place