XTAC

 

XTACInstructions

Description

The XTAC is a soft and flexible, transparent dressing for abdominal wall openings. The XTAC is designed with a pleat that when used as directed, is expandable for swelling.

Indications

The XTACâ„¢ is indicated for the temporary bridging of fascial defects where primary closure is not possible, including, but not limited to abdominal compartment syndrome.

Contraindications

The XTAC is not designed or intended for implantation.

Warnings

FOR SINGLE USE ONLY

Federal law restricts sale of this device to, by, or on the order of a physician.

Use of this device should not otherwise affect the standard of care for the condition being treated.

Pleat expandability to accommodate increased swelling does not eliminate the need to monitor intra-abdominal pressure. Continuous monitoring of clinical parameters should be performed as indicated. Careful attention is required.

The XTAC should be removed as early as clinically feasible, not to exceed five days in length.

Adverse Reactions

Patients with severe abdominal trauma and or abdominal compartment syndrome have a high mortality rate. Careful attention is required.

Contents

The XTAC is supplied as a single unit, double pouched and sterile.

Sterility

Contents are sterile unless the package has been opened or damaged.

Instructions for Use

The XTAC pleat is pushed open, placed over the abdominal viscera, trimmed, and positioned in place by suturing or stapling to the skin. Drain(s) are placed and connected to suction for fluid removal. Pieces of adherent drape are placed around the perimeter to create an air and watertight seal between the XTAC and skin. Alternatively, a slit may be made in the adherent drape the length of the pleat and spread open before applying. Leaving the pleat area uncovered by adherent drape helps preserve space for swelling. Covering the XTAC pleat with adherent drape restricts the amount of space available for swelling.

The XTAC may also be used in a vacuum pack technique. The XTAC pleat is pushed open and placed over the abdominal viscera. The edges are tucked beneath the peritoneun of the abdominal wall. Based on surgeon preference the XTAC may be perforated with a scalpel. Drain(s) are placed and connected to suction for fluid removal. An adherent drape is placed to form an air and watertight seal. Placing the adherent drape loosely helps avoid compression of the expanded pleat volume that is available for swelling. Applying the adherent drape too tightly restricts the amount of space available for swelling.

Precautions

Monitoring of intra-abdominal pressure is important. If intra-abdominal pressure rises above acceptable clinical limits, discontinue use or replace to allow for additional expansion.