Trial Outcomes & Findings for Comparative Study of Biologic Mesh Versus Repair With Component Separation. (NCT NCT01295125)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

two years after surgery date

Results posted on

2023-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	XenMATRIX Use of XenMATRIX mesh to repair hernia XenMATRIX mesh: Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
Overall Study STARTED	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	XenMATRIX Use of XenMATRIX mesh to repair hernia XenMATRIX mesh: Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
Overall Study Study stopped prematurely	9

Baseline Characteristics

Comparative Study of Biologic Mesh Versus Repair With Component Separation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XenMATRIX n=9 Participants Use of XenMATRIX mesh to repair hernia XenMATRIX mesh: Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: two years after surgery date

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years after surgery date

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Number of days up to 1 week

Population: No data collected

Participants will be followed for the duration of the hospital stay, an expected average of 1 week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years after surgery date

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years after surgery date

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years after surgery date

Population: No data collected

Outcome measures

Outcome data not reported

Adverse Events

XenMATRIX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Rosen

University Hosptials Cleveland Medical Center

Phone: 216-396-9937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place