Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

Hernia Clinical Trial

Official title:

A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364233
• Other study ID #: PB-NU-2011-01
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: March 2014

Study information

• Verified date: February 2019
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

Description:

cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired

Exclusion Criteria:

Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study

Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction

Acceptable state of health and nutrition with pre-albumin levels of = 15 mg/dL (0.15 g/L), serum albumin = 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.

For subjects with Diabetes Mellitus, HbA1C <12%

BMI = 40 kg/m²

Related Conditions & MeSH terms

• Hernia

Intervention

Device:
• MotifMESH
Polytetrafluoroethylene (cPTFE) macroporous mesh

Locations

Country	Name	City	State
United States	Division of Plastic Surgery	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh	Hernia occurrence at one year after surgery	1 year