Primary Outcome Measures:
- Close belly button or umbilical hernia [ Time Frame: After surgery, subjects will be followed at intervals of one month and six months from date of surgery. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- At follow up if the hernia has not closed, another surgery may be required to close the umbilical hernia. [ Time Frame: Seven or more months after initial surgery. ] [ Designated as safety issue: No ]
All patients will undergo general anesthesia for their primary procedure, i.e. inguinal hernia repair. Once under general anesthesia, the abdomen will be prepped and draped in the usual sterile surgical fashion. The edge of the umbilical hernia defect will be palpated and in case there are any contents of the hernia present, they will be pushed into the abdominal cavity. Adequate relaxation, again, will be assured. A 24 gauge needle will be used to inject 1cc of Deflux ("Study Product") into each quadrant at the junction between the preperitoneal space and the inner palpable rim of the fascial defect. The surgeon's index finger stays in the center of the hernia defect, protecting the hernia sac contents from re-herniating. Closure of the umbilical defect will be confirmed by palpation immediately after injection. A sterile wound dressing will be applied and the primary surgical procedure will be performed afterwards.
Definition of Primary and Secondary Outcomes/Endpoints:
The endpoint of this study is closure of the umbilical hernia.
Data Collection Methods, Assessments, and Schedule (what assessments performed, how often): A data collection file is started at the time of enrollment in the study. Data collection includes patient age, gender, and weight at the time of operation, inner diameter of the umbilical hernia defect at the time of operation, description of the immediate postoperative results and follow-up exams at two weeks, one month, and six months.