Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00754156
Study type Interventional
Source University of Kentucky
Contact
Status Completed
Phase Phase 4
Start date September 2008
Completion date December 2011

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05568238 - Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen N/A
Completed NCT01968811 - Post Market Clinical Follow Up Study of Avance Foam Abdominal Dressing Kit in Open Abdomen N/A
Completed NCT01864590 - Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol N/A
Withdrawn NCT01010464 - An Adhesion Reduction Plan in the Management of the Surgical Open Abdomen N/A
Recruiting NCT06428370 - Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)
Recruiting NCT04283916 - Botulinum Toxin Injection in the Treatment of Open Abdomen
Terminated NCT00834314 - Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment N/A
Recruiting NCT06242925 - Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO) N/A
Completed NCT01016353 - Open Abdomen Study Comparing ABTheraâ„¢ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
Completed NCT01594385 - Seprafilm in Open Abdomens: a Study of Wound and Adhesion Characteristics in Trauma Damage Control Patients N/A
Completed NCT00494793 - Vacuum Assisted Wound Closure (VAWC) and Mesh Mediated Fascial Traction N/A