ABRA Abdominal Closure System in Open Abdomen Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Rockich, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00754156
First received: September 16, 2008
Last updated: February 15, 2014
Last verified: February 2014
  Purpose

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.

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.


Condition Intervention Phase
Open Abdomen
Device: ABRA Abdominal Closure System
Device: V.A.C. Therapy
Device: KCI ABThera
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Primary Closure Rate [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    The rate in which the abdomen was closed the first time.

  • Number of Trips to the Operating Room [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Operating Room Time Utilization [ Time Frame: Duration of Hospital Stay less than 6 months ] [ Designated as safety issue: No ]
    The amount of time needed to manage the open abdomen inside the operating room.


Secondary Outcome Measures:
  • Days to Closure [ Time Frame: Duration of Hospital Stay less than 6 months ] [ Designated as safety issue: No ]
  • ICU Days [ Time Frame: Duration of hospital stay less than 6 months ] [ Designated as safety issue: No ]
  • Hospital Days [ Time Frame: Duration of Hospital Stay less than 6 months ] [ Designated as safety issue: No ]
  • Blood Transfused [ Time Frame: Duration of Hospital Stay less than 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 ABRA plus KCI ABThera or KCI VAC
ABRA Abdominal Wound Closure System in combination with KCI ABThera or KCI VAC
Device: V.A.C. Therapy
V.A.C. Therapy Alone
Device: KCI ABThera
KCI ABThera
Active Comparator: KCI V.A.C. Therapy or ABThera Alone
KCI V.A.C. Therapy ABThera Alone
Device: ABRA Abdominal Closure System
ABRA Abdominal Closure System
Device: V.A.C. Therapy
V.A.C. Therapy Alone
Device: KCI ABThera
KCI ABThera

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. High risk for imminent death, as determined by the attending surgeon and PI
  2. Pre-existing large ventral hernia
  3. Significant loss of abdominal wall fascia as a result of trauma or infection
  4. Known Crohn's disease
  5. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754156

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Phillip Chang, M.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Anna Rockich, Director, General Surgery Clinical Research Program, University of Kentucky
ClinicalTrials.gov Identifier: NCT00754156     History of Changes
Other Study ID Numbers: 07-0694-F2L
Study First Received: September 16, 2008
Results First Received: July 15, 2013
Last Updated: February 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Closure, Wounds

ClinicalTrials.gov processed this record on August 21, 2014