The purpose of the study is to test the use of "Deflux" injections in a minimally invasive
closure of umbilical (belly button) hernias in infants between birth and five years. The
study is designed to demonstrate that the use of this device can safely and effectively close
an umbilical hernia.
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
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.
- Age 1-5 years
- Umbilical hernia>1cm. diameter.
- Undergoing either a general surgical or urologic procedure under general anesthesia
other than umbilical hernia repair.
- No previous umbilical hernia repair.
- Over 5 years
- No umbilical hernia
- No other surgery required
- Previous umbilical hernia repair