Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair (PPDS)

A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Parietene DS Composite Mesh

Detailed Description

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lakes Regional Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri - Columbia
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Hernia Center of Excellence LLC
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine and Public Health
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Preoperative Inclusion Criteria

  1. Subject has provided informed consent
  2. Subject is ≥18 years of age (at the time of consent)
  3. Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal mesh placement

Exclusion Criteria:

• Preoperative Exclusion Criteria

  1. BMI > 45 kg/m2
  2. Subject is undergoing emergency surgery
  3. Subject is pregnant or planning to become pregnant during study participation period
  4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
  5. Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
  6. The subject has participated in another investigational drug or device research study within 30 days of enrollment
  7. Subject has a parastomal hernia

• Intra-operative Exclusion Criteria

  1. Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
  2. Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
  3. Surgeon is unable to completely remove existing mesh from prior surgery
  4. Surgeon overlays 2 meshes
  5. Subject receives any mesh other than Parietene™ DS composite mesh

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parietene DS Composite Mesh; Patients treated with Parietene DS Composite Mesh	Device: Parietene DS Composite Mesh; All subjects enrolled will receive the Parietene DS Composite Mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair	12 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hernia Recurrence (From Surgery Timepoint)		from time of surgery up to 24 months post-surgery
Time to Adverse Device Effect Occurrence (From Surgery Timepoint)		from the time of surgery up to 24 months post-surgery
Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair.		operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair		1 month, 3 months, and 24 months post-surgery
Carolinas Comfort Scale™ Quality of Life Questionnaire Completed Pre-operatively and at 1 Month,12 Months and 24 Months Post-operatively	The Carolina Comfort Scale is a validated, disease specific, questionnaire developed for participants to assess quality of life pre- and post- hernia repair with mesh. Each question on the questionnaires is scored on a scale of 0-5 with 0 indicating no symptoms and 5 indicating disabling symptoms. The Carolina Comfort Scale measures severity of pain (Min Score: 0, Max Score: 40), sensation of mesh (post-operative assessment only, Min Score: 0, Max Score: 40), and movement limitations (Min Score: 0, Max Score: 35) in the following eight categories: lying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking up stairs, and exercise. An average of the 8 categories is computed at each timepoint for each of the 3 questionnaires with the best possible score of 0 and the worst possible score of 115. A lower score on the questionnaire would indicate a better outcome.	pre-operatively, 1 month, 12 months and 24 months post-operatively

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Study Director: Sue Kim, Medtronic - Surgical Innovations

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 6, 2022

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: MDT17051PDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No