TAWT Instructions for Use
The following is based on the package insert for the TAWT™ Skin-Protecting Bolster Plate. Also see the Wittmann Patch use instructions.
Description
The TAWT skin protecting bolster plate is an overlapping, foam-padded, semirigid plastic strip designed to provide for external fixation and skin protection when using the Wittmann Patch™ as a temporary underlay abdominal closure. The bolster plate has a series of holes that allow for the passage of suture for external attachment of the bolster plates to the Wittmann Patch.
Indications For Use
The TAWT device aids in application of traction during staged closure of the abdominal wall by providing fixation of a Wittmann Patch temporary closure device to the inner surface of the abdominal wall.
Contraindications
The skin protecting bolster plates are for external use only.
Contents
Four bolster plates per package. Contents are sterile unless the enclosed package has been opened or damaged.
Warnings
FOR SINGLE PATIENT 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.
Adverse Reactions
Patients with severe abdominal trauma and/or abdominal compartment syndrome have a high mortality rate. Careful attention is required.
Precautions
Excessive bolster pressure may cause skin necrosis.
Care should be taken to avoid the vascular bundle within the rectus muscle when placing suture to secure the Wittmann Patch to the bolster plate.
When using the Wittmann Patch with the bolster plate, continuous monitoring of clinical parameters should be performed as indicated. If intra-abdominal pressure exceeds acceptable clinical limits, the Wittmann Patch should be opened. If this does not resolve the situation, the TAWT device should be removed.
This device should be used in accordance with institutional standards for the critical care patient. Institutional standards typically include, but are not limited to, patient monitoring, pain control, and antibiotic therapy.
Instructions for use
A Wittmann Patch—20 cm × 40 cm loop sheet, "fuzzy" side facing up, and 10 cm × 40 cm hook sheet, "rough side" facing down—is placed into the abdomen as a temporary underlay between the peritoneal surface of the abdominal wall and an underlying visceral organ protective layer (KCI Abdominal VAC® or AbThera™, Smith & Nephew Renaysis™).
Two bolster plates are positioned on each side of the abdominal wound. The plates are positioned over the lateral rectus sheath and approximate the contour of the open wound. Hydrocolloid dressings are applied to the skin beneath the bolster plates to provide additional skin protection and padding. For shorter length wound openings, the bolster plate may be trimmed, taking care to round any sharp edges of the plastic strip and allowing extra foam padding to extend beyond the edges of the bolster plate.
The Wittmann Patch hook and loop sheets are firmly fixed to the underside of the abdominal wall with a large needle braided polyester suture (#5 Ethibond Excel® or Covidien TiCron™) passing first through a bolster plate hole, through skin and all tissue layers lateral to the vascular bundle at the lateral rectus sheath, through the underlay hook sheet, and then exiting back out the hook sheet through all tissue layers, skin, and through the adjacent hole in the bolster plate. A knot is tied between the two bolster plate holes firmly securing the underlay sheet to the peritoneal underside of the abdominal wall. The process is repeated for the other bolster plate on the same side and then for the bolster plates and loop sheet on the other side. In this way the abdominal wall is essentially sandwiched between the hook and loop sheets and the padded bolster plates. In a typical application a bolster plate hole may be skipped between sutures.
Note: Making the hook and loop sheet entry and exit hole distance less than the 1" bolster plate hole distance helps prevent hook and loop sheet wrinkling when the knot is tied over the bolster plate.
Note: In the obese patient, tissue layers may be too thick to allow for suture needle passage. An endoscopic needle may facilitate suture passage.
The negative pressure dressing is applied. As clinical circumstances allow approximately every 48 hours, the Wittmann Patch sheets are opened and gradually pulled closer together. Excess hook sheet material is trimmed.
When the fascial edges of the abdominal wall are approximated, the sutures securing the bolster plate to the Wittmann Patch are cut, the Wittmann Patch is removed, and the abdominal wall is suture closed.