N/A
N=25
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Ventral Hernia · Incisional Hernia
Bottom Line
View on ClinicalTrials.gov: NCT02053168 ↗Enrolled (actual)
25
Serious AEs
24.0%
Results posted
May 2018
Primary outcome: Primary: Number of Participants With Hernia Recurrence — 0; 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resorbable Mesh (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hernia Recurrence |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Device Related Adverse Events |
1 | — |
| SECONDARY Carolinas Comfort Scale (CCS) Total Score - Change From Baseline |
-1.1 | — |
| SECONDARY Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline) |
-5.3 | — |
| SECONDARY Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline) |
-9.4 | — |
| SECONDARY Surgical Procedure Time |
242.5 | — |
| SECONDARY Length of Hospital Stay |
5.0 | — |
| SECONDARY Number of Study Related Post Operative Surgical Procedures |
7 | — |
| SECONDARY Number of Study Related Post Operative New Hospital Admissions |
5 | — |
| SECONDARY Number of Related Post-operative Visits Unrelated to Standard of Care |
8 | — |
| SECONDARY Incidence of Seroma |
1 | — |
Summary
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Eligibility Criteria
Inclusion Criteria
- Subject or subject's legally authorized representative must be willing to give written informed consent
- Subject must be diagnosed with ventral or incisional hernia
- Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Exclusion Criteria
- Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
- Subject's hernia has recurred four or more times.
- Subject's body mass index (BMI) >40 kg/m2.
- Subject has peritonitis.
- Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
- Chronic steroid use or immunosuppression drugs (> 6 months).
- Subject has cirrhosis, and/or ascites.
- Subject is American Society of Anesthesiology Class 4 or 5.
- Subject is pregnant or planning to become pregnant during the course of the study.
- Subject is known to be infected with human immunodeficiency virus (HIV).
- Subject has a life expectancy of less than 2 years at the time of enrollment.
- Subject has been treated with an investigational product in the past 30 days.
- Subject is part of the site personnel directly involved with this study
- Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
- 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
Data sourced from ClinicalTrials.gov (NCT02053168). 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.