ABRA Abdominal Closure System in Open Abdomen Management

Open Abdomen Clinical Trial

— ABRA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754156
• Other study ID #: 07-0694-F2L
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: February 15, 2014
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Open Abdomen

Intervention

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

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Closure Rate	The rate in which the abdomen was closed the first time.	up to 12 months	Yes
Primary	Number of Trips to the Operating Room		12 Months	Yes
Primary	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	No
Secondary	Days to Closure		Duration of Hospital Stay less than 6 months	No
Secondary	ICU Days		Duration of hospital stay less than 6 months	No
Secondary	Hospital Days		Duration of Hospital Stay less than 6 months	No
Secondary	Blood Transfused		Duration of Hospital Stay less than 6 months	Yes