Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question <Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?> is answered with <yes>

Proportions 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. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question <Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?> is answered with <yes> "

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.

Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections.

Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month follow up. Scores are measured on a 10.0 cm line, lower values correspond with low 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. A negative score means a decrease in pain perception.

Incidence Device-related Adverse Events: number of subjects with one or more possibly or definitely device-related Adverse Event.

Rate of reoperation due to the index hernia repair: the proportion of subjects with post-procedure reoperation due to the index hernia repair.

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 1-Month follow-up, at 3-Month follow-up, at 12-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.

Change in self-reported quality of life measured by EuroQol-5 Dimensions (EQ-5D™). Each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has 3 levels (no problems, some problems and extreme problems). The data is converted into a summary index number between 0 and 1, whereby 1 corresponds with the highest perception of Quality of Life. The outcome measure reports the absolute change from Baseline until 24-months follow up. A positive value corresponds with an increase in Quality of Life.

Surgical procedure time as measured from incision to closure (skin to skin)

The number of days until subject returned to work, calculated as the date when employed subjects were able to fully get back to work minus the date of surgery.

The length of hospital stay for the index procedure is calculated as the date of hospital discharge minus the date of hospital admission. Days in intensive care unit, days in step down unit (medium care) and days in the ward will be summarized as well.