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Open AbdomenPhase 4ABRANCT00754156

ABRA Abdominal Closure System in Open Abdomen Management

A Phase 4 study testing ABRA Abdominal Closure System, V.A.C. Therapy and KCI ABThera in people with Open Abdomen, run by Anna Rockich at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal compartment syndrome, and critically ill surgical patients with profound acidosis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Open Abdomen
What is being tested?
ABRA Abdominal Closure System, V.A.C. Therapy and KCI ABThera
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
Sep 2008to Dec 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ages of 18 and 70
  • patients deemed not a candidate for primary fascial closure at the second laparotomy.

Who cannot join

  • High risk for imminent death, as determined by the attending surgeon and PI
  • Pre-existing large ventral hernia
  • Significant loss of abdominal wall fascia as a result of trauma or infection
  • Known Crohn's disease
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: A Prospective, Controlled Evaluation of ABRA Abdominal Wall Closure System in Combination With V.A.C. Therapy Compared to V.A.C. Alone in the Management of Open Abdomen

For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal compartment syndrome, and critically ill surgical patients with profound acidosis. While these advances have saved lives, they have also led to a dramatic increase in patients with open abdominal cavities. Various methods have been employed to offer protection to the viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch , and the use of vacuum assisted fascia-closure, including the commercially available system offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an average of 10 days. Unfortunately, there has been no well-designed comparison study available. Some of the best results also require returning to the operating room every 3 to 5 days.

At the University of Kentucky Medical Center, a combination of the vacuum pack dressing described by Barker, the commercially available VAC system (V.A.C.; KCI International, San Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is approximately 50%. It is not standard practice to take patients to the OR every 3-5 days routinely.

Read more

Recently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic reduction of full thickness, severely retracted midline abdominal defects with the goal of maintaining or restoring the primary closure option. This subdermal method uses button anchors and elastomer to gradually pull the wound margins together. Tension can be set and adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound, close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there is only one published case report of the success of this device. We hope to be the first center to prospectively report a series of patients with open abdomen managed with the new ABRA system. In this study, this system will be used in combination with a standard therapy used in abdominal wound closure at the University of Kentucky Medical Center. This system is called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides active exudate management and containment, assists in reducing abdominal volume and adds structural stabilization to adipose tissue.

Although no highly powered study has been done to establish data on performance, individual experiences at several institutions have reached fascial closure rates of higher than 70% using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in combination with the VAC system and has experienced 100% closure rate to date with 12 patients. The purpose of this study is to collect information about the ABRA system in combination with the VAC technique at the University of Kentucky Medical Center. It is our belief that using this system will improve the fascial closure rate and thereby produce less chance of hernia and reduce long periods of open abdominal wounds. The objective of the study is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system combined with the K.C.I. VAC System to KCI VAC System alone.

Conditions
Open Abdomen
Being tested
ABRA Abdominal Closure System, V.A.C. Therapy, KCI ABThera
Keywords
Closure, Wounds
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABRA Abdominal Closure SystemDevice

    ABRA Abdominal Closure System

  • V.A.C. TherapyDevice

    V.A.C. Therapy Alone

  • KCI ABTheraDevice

    KCI ABThera

Study groups in NCT00754156
Study groupRoleWhat they receive
1 ABRA plus KCI ABThera or KCI VACActive comparatorABRA Abdominal Wound Closure System in combination with KCI ABThera or KCI VAC
Receives: Device: V.A.C. Therapy; Device: KCI ABThera
KCI V.A.C. Therapy or ABThera AloneActive comparatorKCI V.A.C. Therapy ABThera Alone
Receives: Device: ABRA Abdominal Closure System; Device: V.A.C. Therapy; Device: KCI ABThera

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Closure Rate

    The rate in which the abdomen was closed the first time.

    Measured: up to 12 months

  2. Number of Trips to the Operating Room

    Measured: 12 Months

  3. Operating Room Time Utilization

    The amount of time needed to manage the open abdomen inside the operating room.

    Measured: Duration of Hospital Stay less than 6 months

Secondary outcomes (4)
  1. Days to Closure

    Measured: Duration of Hospital Stay less than 6 months

  2. ICU Days

    Measured: Duration of hospital stay less than 6 months

  3. Hospital Days

    Measured: Duration of Hospital Stay less than 6 months

  4. Blood Transfused

    Measured: Duration of Hospital Stay less than 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00754156
Sponsor's protocol ID
07-0694-F2L
Acronym
ABRA
Status last verified
Feb 2014
First submitted
16 Sep 2008
Last updated
3 Mar 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ABRA Abdominal Closure System, V.A.C. Therapy and KCI ABThera in people with Open Abdomen, run by Anna Rockich 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Mar 2017. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Closure Rate (time frame: up to 12 months). The study lists 3 primary outcomes in all. 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 Mar 2017.

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