The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae

Withdrawn before enrolling · Not applicable

Conditions studied: Fistulae

In brief

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.

Key facts

Study ID

NCT02519192

Run by

Denver Health and Hospital Authority

People needed

0

Starts

2016-01-01

Expected to finish

2017-01-01

Last updated by the study team

2018-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• post-laparotomy patient developing a new enterocutaneous fistula

You may not qualify if…

• 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.

Where it is running

• Denver Health Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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