N/A
Completed N=84
Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
hernia · Hernia, Abdominal · Hernia, Incisional
Source: ClinicalTrials.gov NCT02720042 ↗
Enrolled (actual)
84
Serious AEs
47.6%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure — 22 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure |
22 | — |
| SECONDARY Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure |
22 | — |
| SECONDARY Number of Participants With a Hernia Recurrence |
8 | — |
| SECONDARY Number of Participants With One or More Surgical Site Infection |
12 | — |
| SECONDARY 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 |
-0.7 | — |
| SECONDARY Number of Participants With One or More Device-related Adverse Event |
16 | — |
| SECONDARY Number of Participants Requiring Reoperation Due to Index Hernia Repair |
13 | — |
| SECONDARY 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 |
0.6; 0.5; 0.3; 0.3 | — |
| SECONDARY Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure |
0.11 | — |
| SECONDARY Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure |
198 | — |
| SECONDARY Mean Time Until Participants Were Able to Return to Work |
101.3 | — |
| SECONDARY Mean Length of Hospital Stay Related to Index Procedure |
10.9; 1.0; 0.3; 9.5 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02720042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.