NCT02712398CompletedNot Applicable
A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair
C. R. Bard32 sites in 1 country120 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 32
- Primary Endpoint
- Surgical Site Occurrence Rate
Study Overview
Brief Summary
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).
Detailed Description
Subjects at high risk are defined as having 1 or more of the following co-morbid conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must be 18 years of age or older
- •Subject must be willing to give written informed consent
- •Subject must be diagnosed with ventral or abdominal incisional hernia
- •Subject must be willing to undergo laparoscopic hernia repair using intraabdominal placement (with or without Component Separation Technique (CST))
- •Surgeon must be able to fully close the hernia defect. Defect closure is defined as complete reapproximation of fascial edges, leaving no gap. Since the safety and effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect should be closed prior to mesh use.
- •Subject is expected to meet the criteria for a Class I wound
- •Subjects must have 1 or more of the following pre-study conditions:
- •Body Mass Index (BMI) between 30-40 kg/m2, inclusive
- •Active smoker (including 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)
- •COPD presence on patient self-report
- •Diabetes mellitus (if yes, diagnosis to be confirmed via medical records or laboratory results according to 2014 Joslin Clinical Guideline for Adults with Diabetes)(Appendix 5)
- •Immunosuppression
- •Coronary Artery Disease
- •Chronic corticosteroid use: greater than 6 months systemic use
- •Serum albumin less than 3.4 g/dL
- •Advanced age: 75 years or older
- •Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL
Exclusion Criteria
- •Subject has had 4 or more previous hernia repairs (of the index hernia)
- •Subject's hernia is > 350 cm2
- •Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible
- •Subject has intact permanent mesh adjacent to the current hernia to be repaired
- •Preperitoneal placement of mesh
- •The subject is known to have a collagen disorder
- •The subject has peritonitis
- •The subject is on or suspected to be placed on chemotherapy medications during any part of the study
- •The subject's Body Mass Index (BMI) is > 40 kg/m2
- •The subject has cirrhosis of the liver and/or ascites
- •Subject is American Society of Anesthesiology Class 4 or 5
- •Subject has a life expectancy of less than 2 years at the time of enrollment
- •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 has a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated)
- •Subject has an active or latent systemic infection
- •Patient has a contraindication to placement of mesh
- •Subject requires surgical bridge repair as the sole repair
- •Subject is pregnant or has plans to become pregnant during the study period
- •Subject has enrolled in another interventional clinical study within the last 30 days
- •Subject is part of the site personnel directly involved with this study
- •Subject has a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).
Outcomes
Primary Outcomes
Surgical Site Occurrence Rate
Time Frame: 45 Days
Proportion of subjects with Surgical Site Occurrences(SSO), which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 45 days.
Secondary Outcomes
- Surgical Site Occurrence Rate(3 months)
- Hernia Recurrence Rate(24 Months)
- Pain Visual Analog Scale(24 Months)
- Device-related Adverse Event Incidence(24 Months)
- Rate of Reoperation Due to Index Hernia Repair(24 Months)
- Change in Carolinas Comfort Scale(24 Months)
- Change in SF(Short-form)-12(24 Months)
- Surgical Procedure Time as Measured From Incision to Closure(During Procedure, up to 243 minutes)
- Length of Hospital Stay(1 month)
Investigators
Study Sites (32)
Loading locations...
Similar Trials
Completed
Not Applicable
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant SystemHearing LossNCT04754477Cochlear20
Active, not recruiting
Phase 3
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With RemibrutinibChronic Spontaneous UrticariaNCT05513001Novartis Pharmaceuticals696
Not yet recruiting
Not Applicable
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD InjAtopic DermatitisNCT04730024Kang Stem Biotech Co., Ltd.102
Completed
Not Applicable
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault ProlapseUrinary Incontinence, StressMixed IncontinenceVaginal Vault ProlapseNCT00223106Medtronic - MITG467
Completed
Phase 2
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)Alagille SyndromeNCT02047318Mirum Pharmaceuticals, Inc.19