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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
Yale-New Haven Medical Center
New Haven, Connecticut, United States
Florida Hospital
Celebration, Florida, United States
Surgical Site Occurrence Rate
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.
Time frame: 45 Days
Surgical Site Occurrence Rate
Number of subjects with Surgical Site Occurrences, 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 3 months.
Time frame: 3 months
Hernia Recurrence Rate
Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.
Time frame: 24 Months
Pain Visual Analog Scale
Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month through follow up. Scores are measured on a 10.0 cm line, scores range from 0 to 10, higher values correspond with higher pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up.
Time frame: 24 Months
Device-related Adverse Event Incidence
Proportion of subjects with Investigator-determined device-related adverse events
Time frame: 24 Months
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Emory University
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Via-Christi Hospital
Wichita, Kansas, United States
Georgetown Community Hospital
Georgetown, Kentucky, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Washington University
St Louis, Missouri, United States
Methodist Hospital
Omaha, Nebraska, United States
...and 6 more locations
Rate of Reoperation Due to Index Hernia Repair
Rate of reoperation due to the index hernia repair
Time frame: 24 Months
Change in Carolinas Comfort Scale
Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties. Absolute values of the Total CCS Score at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported. The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.
Time frame: 24 Months
Change in SF(Short-form)-12
The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Absolute values of the PCS and MCS scores at Baseline, 1-Month follow-up, at 3-Month follow-up, at 6-Month follow-up, at 12-Month follow-up, at 18-Month follow-up, and at 24-Month follow up are reported.
Time frame: 24 Months
Surgical Procedure Time as Measured From Incision to Closure
Surgical procedure time as measured from incision to closure (skin to skin)
Time frame: During Procedure, up to 243 minutes
Length of Hospital Stay
Number of days admitted to the hospital for index surgery
Time frame: 1 month