Trial Outcomes & Findings for Safety Study of MotifMESH (cPTFE) in Abdominal Surgery (NCT NCT01364233)
NCT ID: NCT01364233
Last Updated: 2019-02-26
Results Overview
Hernia occurrence at one year after surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 year
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
MotifMesh
Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh
MotifMESH: Surgical mesh
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
MotifMesh
Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh
MotifMESH: Surgical mesh
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
Baseline characteristics by cohort
| Measure |
MotifMesh
n=10 Participants
Participants received Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearHernia occurrence at one year after surgery
Outcome measures
| Measure |
Hernia Occurrence at One Year After Surgery
n=9 Participants
Number of subjects who had an additional hernia occur following surgery with Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh post 1 year after initial surgery.
|
|---|---|
|
Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh
|
0 participants
|
Adverse Events
MotifMesh
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 |
MotifMesh
n=10 participants at risk
Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh
MotifMESH: Surgical mesh
|
|---|---|
|
Injury, poisoning and procedural complications
Hematoma
|
10.0%
1/10 • Number of events 1 • 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place