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

Fistulae Clinical Trial

— ECF  

Official title:

The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02519192
• Other study ID #: 15-2133
• Status: Withdrawn
• Phase: N/A
• First received: July 28, 2015
• Last updated: December 29, 2017
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: December 2017
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 necessary.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• post-laparotomy patient developing a new enterocutaneous fistula

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fistula
• Fistulae
• Intestinal Fistula

Intervention

Device:
• V.A.C.Ulta™ Negative Pressure Wound Therapy System
VAC Arm 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) .

Procedure:
• Vac sponge irrigations
VAC Arm 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) .
• ostomy bag
Non Vac Arm will receive ostomy bag applications.
• wet to dry dressings
Non Vac arm will receive wet to dry dressing changes.

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	KCI USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary endpoint of time to fistula closure	Study subjects will be followed until closure of the enterocutaneous fistula, an expected average of 6-8 weeks.	Expected average of 6-8 weeks