Clinical trial NCT02720042: Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
Official title: A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Hernia, Abdominal
Hernia, Incisional
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

Detailed description: Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.

Eligibility criteria: Inclusion Criteria:

* Subject must be diagnosed with incisional midline hernia.
* Subject has a VHWG Grade 3 hernia (as defined in the protocol).
* Size of hernia ≥ 10 cm2.
* Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique.

Exclusion Criteria:

* Subject with \> 4 previous repairs of the hernia under observation.
* Body Mass Index (BMI) \> 35 kg/m2.
* The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
* The subject has peritonitis.
* Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
* The subject has cirrhosis of the liver and/or ascites.
* Subject is American Society of Anesthesiology Class 4 or 5.
* Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
* The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
* Subject has intact permanent mesh adjacent to the current hernia to be repaired.
* Subject's hernia repair requires intraabdominal mesh placement.
* Surgical technique requires surgical bridge repair as the sole repair.
* Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
* Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
* Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
* Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature.
* Subject is part of the site personnel directly involved with this study.
* Subject has a life expectancy of less than 2 years at the time of enrollment.
* Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).

Primary outcomes:
measure: Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure
timeFrame: 3 Months
Secondary outcomes:
measure: Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure
timeFrame: 24 Months
measure: Number of Participants With a Hernia Recurrence
timeFrame: 24 Months
measure: Number of Participants With One or More Surgical Site Infection
timeFrame: 24 Months
measure: Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale
timeFrame: 24 Months
measure: Number of Participants With One or More Device-related Adverse Event
timeFrame: 24 Months
measure: Number of Participants Requiring Reoperation Due to Index Hernia Repair
timeFrame: 24 Months
measure: Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure
timeFrame: 24 Months
measure: Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure
timeFrame: 24 Months
measure: Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure
timeFrame: 1 day
measure: Mean Time Until Participants Were Able to Return to Work
timeFrame: 24 Months
measure: Mean Length of Hospital Stay Related to Index Procedure
timeFrame: 1 Month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven (Gasthuisberg)
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Cottbus
country: Germany
facility: Day Surgery and Hernia Center
state: Brandenburg
city: Berlin
country: Germany
facility: Vivantes Hospital
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Capelle Aan Den IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Helmond
country: Netherlands
facility: Elkerliek Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala
city: London
country: United Kingdom
facility: University College London Hospitals NHS Trust
Study officials:
affiliation: Erasmus University Medical Centre Rotterdam
name: Hans Jeekel
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Rooijen MMJ, Tollens T, Jorgensen LN, de Vries Reilingh TS, Piessen G, Kockerling F, Miserez M, Windsor ACJ, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GWM, Koch A, Jeekel J. Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. Hernia. 2022 Feb;26(1):131-138. doi: 10.1007/s10029-021-02453-1. Epub 2021 Jul 19.
citation: van Rooijen MMJ, Jairam AP, Tollens T, Jorgensen LN, de Vries Reilingh TS, Piessen G, Kockerling F, Miserez M, Windsor ACJ, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GWM, Koch A, Kroese LF, Jeekel J. A post-market, prospective, multi-center, single-arm clinical investigation of Phasix mesh for VHWG grade 3 midline incisional hernia repair: a research protocol. BMC Surg. 2018 Nov 20;18(1):104. doi: 10.1186/s12893-018-0439-7.