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The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae (ECF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519192
Recruitment Status : Withdrawn (Research personal no longer available)
First Posted : August 10, 2015
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
KCI USA, Inc.
Information provided by (Responsible Party):
Denver Health and Hospital Authority

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.

Condition or disease Intervention/treatment Phase
Fistulae Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System Procedure: Vac sponge irrigations Procedure: ostomy bag Procedure: wet to dry dressings Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae: A Randomized Controlled Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: VAC Arm, Vac sponge irrigations
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
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) .

Active Comparator: NonVac, ostomy bag, wet to dry dressings
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
Non Vac Arm will receive ostomy bag applications.

Procedure: wet to dry dressings
Non Vac arm will receive wet to dry dressing changes.




Primary Outcome Measures :
  1. primary endpoint of time to fistula closure [ Time Frame: Expected average of 6-8 weeks ]
    Study subjects will be followed until closure of the enterocutaneous fistula, an expected average of 6-8 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519192


Locations
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United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
KCI USA, Inc.
Investigators
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Principal Investigator: Fredric M Pieracci, MD MPH Denver Health Medical Center
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Responsible Party: Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02519192    
Other Study ID Numbers: 15-2133
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Intestinal Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases