ABRA Abdominal Closure System in Open Abdomen Management

NCT00754156 | Completed Phase 4 Results

• 1 other identifier: 07-0694-F2L
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Open Abdomen

Keywords

Closure, Wounds

Outcome Measures

Primary Outcomes (3)

• Primary Closure Rate

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

  up to 12 months

• Number of Trips to the Operating Room

  12 Months

• Operating Room Time Utilization

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

  Duration of Hospital Stay less than 6 months

Secondary Outcomes (4)

• Days to Closure

  Duration of Hospital Stay less than 6 months

• ICU Days

  Duration of hospital stay less than 6 months

• Hospital Days

  Duration of Hospital Stay less than 6 months

• Blood Transfused

  Duration of Hospital Stay less than 6 months

Study Arms (2)

1 ABRA plus KCI ABThera or KCI VAC

ACTIVE COMPARATOR

ABRA Abdominal Wound Closure System in combination with KCI ABThera or KCI VAC

Device: V.A.C. Therapy; Device: KCI ABThera

KCI V.A.C. Therapy or ABThera Alone

ACTIVE COMPARATOR

KCI V.A.C. Therapy ABThera Alone

Device: ABRA Abdominal Closure System; Device: V.A.C. Therapy; Device: KCI ABThera

Interventions

ABRA Abdominal Closure System DEVICE

ABRA Abdominal Closure System

KCI V.A.C. Therapy or ABThera Alone

V.A.C. Therapy DEVICE

V.A.C. Therapy Alone

1 ABRA plus KCI ABThera or KCI VAC; KCI V.A.C. Therapy or ABThera Alone

KCI ABThera DEVICE

KCI ABThera

1 ABRA plus KCI ABThera or KCI VAC; KCI V.A.C. Therapy or ABThera Alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anna Rockich: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

1. Limited by small sample size, and lack of closely matched patient groups. 2. Limited by product change from the original VAC to the ABThera system mid study. 3. Limited by a significant learning curve in application and use of the ABRA device.

Results Point of Contact

• Title: Phillip Chang, M.D. PI or Anna Rockich, Pharm.D. GSRP Director
• Organization: University of Kentucky Medical Center

arockich@uky.edu

859-323-6346

Study Officials

• Phillip Chang, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, General Surgery Clinical Research Program

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 17, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 3, 2017
• Results First Posted: March 18, 2014

Record last verified: 2014-02

Locations

US (1)