This study hopes to determine if a negative pressure dressing is superior to a traditional
dressing for speeding fistula closure after laparotomy. This study has a broad variety of
implications. Patient safety is a paramount concern: Investigators hope to identify a
superior method of wound management which minimizes risk for skin breakdown, sepsis, and
morbidity. In addition, patient satisfaction would be improved with a method for faster wound
healing. Finally,implications exist in the realm of a cost-benefit analysis, for example,
although the VAC method is more costly, it may save money if it speeds healing and prevents
the need for reoperation. Alternatively, if the VAC method is not shown to be beneficial,
physicians can avoid using a more costly device with no proven benefit.
Investigators are planning a superiority trial to show that VAC use speeds the closure of
enterocutaneous fistulae over routine gravity drainage. The investigators' design is a
randomized controlled trial with two arms. One of the arms (non-VAC) will include patients
assigned to a system of ECFoutput management which does not involve negative pressure (for
example, an ostomy bag placed over the fistula, wet to dry dressing changes, etc..), and the
second arm (VAC) will consist of a group of patients assigned to VAC negative pressure
therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure
Wound Therapy System) .
The fistula vac is made from standard sponge supplies and negative pressure suction devices.
Initial placement will be by the bedside physician in the intensive care unit, the ward, or
in the clinic. The patient will be taught basic wound care, and as is typical for those
outpatients with wound VACs, a home nursing aide will be arranged. Those randomized to no VAC
therapy will have ostomy bags or wet to dry dressings placed on the skin with no negative
pressure applied. Again, initial application will be performed by the bedside physician or a
wound care nurse. The patient will be taught wound care, with assistance provided as
Once a fistula is noted to have closed (effluent = 0cc/day) the dressings or VAC will be
discontinued, and the date of fistula closure noted.
- post-laparotomy patient developing a new enterocutaneous fistula
- patient with a prior history of abdominal radiation
- patient with a distal obstruction, any entero-atmospheric fistula, or any patient with
a history of intra-abdominal or metastatic cancer.