Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

• ClinicalTrials.gov Identifier: NCT01364233
• Recruitment Status: Completed
• First Posted: June 2, 2011
• Results First Posted: December 4, 2018
• Last Update Posted: February 26, 2019
• Sponsor: Medline Industries
• Information provided by (Responsible Party): Medline Industries

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hernia
• Intervention: Device: MotifMESH
• Enrollment: 10

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	MotifMesh
Arm/Group Description	Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh MotifMESH: Surgical mesh
Period Title: Overall Study
Started	10
Completed	9
Not Completed	1
Reason Not Completed
Lost to Follow-up	1

Baseline Characteristics

Arm/Group Title		MotifMesh
Arm/Group Description		Participants received Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
Overall Number of Baseline Participants		10
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	9 90.0%
	>=65 years	1 10.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	10 participants
	Female	4 40.0%
	Male	6 60.0%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh
Description	Hernia occurrence at one year after surgery
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hernia Occurrence at One Year After Surgery
Arm/Group Description:	Number of subjects who had an additional hernia occur following surgery with Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh post 1 year after initial surgery.
Overall Number of Participants Analyzed	9
Measure Type: Number; Unit of Measure: participants
	0

Adverse Events

Time Frame	1 year.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MotifMesh
Arm/Group Description	Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh MotifMESH: Surgical mesh
All-Cause Mortality
	MotifMesh
	Affected / at Risk (%)
Total	0/10 (0.00%)
Serious Adverse Events
	MotifMesh
	Affected / at Risk (%)	# Events
Total	0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	MotifMesh
	Affected / at Risk (%)	# Events
Total	1/10 (10.00%)
Injury, poisoning and procedural complications
Hematoma † 1 [1]	1/10 (10.00%)	1
1 Term from vocabulary, Hematoma; † Indicates events were collected by systematic assessment; [1] Small hematoma located in the lateral incision for performance of a components release, hematoma was drained and resolved.

Limitations and Caveats

[Not Specified]

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.

Results Point of Contact

• Name/Title: Ed Drower
• Organization: Medline Industries, Inc.
• Phone: 847-643-3874
• EMail: edrower@medline.com

• Responsible Party: Medline Industries
• ClinicalTrials.gov Identifier: NCT01364233
• Other Study ID Numbers: PB-NU-2011-01
• First Submitted: May 27, 2011
• First Posted: June 2, 2011
• Results First Submitted: August 29, 2017
• Results First Posted: December 4, 2018
• Last Update Posted: February 26, 2019