FistulaeECFNCT02519192
The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae
A study testing V.A.C.Ulta™ Negative Pressure Wound Therapy System, Vac sponge irrigations and ostomy bag in people with Fistulae, run by Denver Health and Hospital Authority at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fistulae
- What is being tested?
- V.A.C.Ulta™ Negative Pressure Wound Therapy System, Vac sponge irrigations and ostomy bag
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post-laparotomy patient developing a new enterocutaneous fistula
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Fistulae
- Being tested
- V.A.C.Ulta™ Negative Pressure Wound Therapy System, Vac sponge irrigations, ostomy bag, wet to dry dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V.A.C.Ulta™ Negative Pressure Wound Therapy SystemDevice
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 sponge irrigationsProcedure or surgery
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 bagProcedure or surgery
Non Vac Arm will receive ostomy bag applications.
wet to dry dressingsProcedure or surgery
Non Vac arm will receive wet to dry dressing changes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: ostomy bag; Procedure: wet to dry dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Expected average of 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Research personal no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FistulaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- KCI USA, Inc
- Responsible party
- Sponsor
- Investigators
- Fredric M Pieracci, MD MPH, Principal investigator, Denver Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519192
- Sponsor's protocol ID
- 15-2133
- Acronym
- ECF
- Status last verified
- Dec 2017
- First submitted
- 28 Jul 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of VAC Therapy Devices in Promoting Closure of Enterocutaneous Fistulae: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02519192
- Acronym / sponsor ID
- ECF / 15-2133
- Conditions
- Fistulae
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research personal no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- KCI USA, Inc
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAC Arm, Vac sponge irrigations | Experimental | Device: V.A.C.Ulta™ Negative Pressure Wound Therapy System, Procedure: Vac sponge irrigationsFor 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. |
| NonVac, ostomy bag, wet to dry dressings | Active comparator | Procedure: ostomy bag, Procedure: wet to dry dressingsFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post-laparotomy patient developing a new enterocutaneous fistula
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V.A.C.Ulta™ Negative Pressure Wound Therapy SystemVAC 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) . | Device | VAC Arm, Vac sponge irrigations |
| Vac sponge irrigationsVAC 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 or surgery | VAC Arm, Vac sponge irrigations |
| ostomy bagNon Vac Arm will receive ostomy bag applications. | Procedure or surgery | NonVac, ostomy bag, wet to dry dressings |
| wet to dry dressingsNon Vac arm will receive wet to dry dressing changes. | Procedure or surgery | NonVac, ostomy bag, wet to dry dressings |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredric M Pieracci, MD MPH principal investigator
Denver Health Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V.A.C.Ulta™ Negative Pressure Wound Therapy System, Vac sponge irrigations and ostomy bag in people with Fistulae, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endpoint of time to fistula closure (time frame: Expected average of 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.