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

NCT02519192 | Withdrawn DMC

• 1 other identifier: 15-2133
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fistulae

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

VAC Arm, Vac sponge irrigations

EXPERIMENTAL

For patients who fall under the VAC arm, a physician will do the initial placement of the wound VAC (V.A.C.Ulta™ Negative Pressure Wound Therapy System) at the patient's bedside. An information sheet will be provided to the patient, and the patient will be taught how to irrigate the sponge system independently. While inpatient, nursing will perform VAC sponge irrigation.

Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System; Procedure: Vac sponge irrigations

NonVac, ostomy bag, wet to dry dressings

ACTIVE COMPARATOR

For patients who fall under the non-VAC arm, a physician or wound care nurse will perform the initial application of the ostomy bag or wet to dry dressing change. An information sheet will be provided to the patient. While inpatient, members from the nursing or physician team will perform ostomy bag application and ostomy dressing changes.

Procedure: ostomy bag; Procedure: wet to dry dressings

Interventions

V.A.C.Ulta™ Negative Pressure Wound Therapy System DEVICE

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) .

VAC Arm, Vac sponge irrigations

Vac sponge irrigations PROCEDURE

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) .

VAC Arm, Vac sponge irrigations

ostomy bag PROCEDURE

Non Vac Arm will receive ostomy bag applications.

NonVac, ostomy bag, wet to dry dressings

wet to dry dressings PROCEDURE

Non Vac arm will receive wet to dry dressing changes.

NonVac, ostomy bag, wet to dry dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• KCI USA, Inc: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Study Officials

• Fredric M Pieracci, MD MPH

  Denver Health Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 10, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)