Product Insert

Description
Superstat® is a biocompatible agent of collagen origin which has been treated to provide a net positive charge. Superstat® is a modified collagen hemostatic sponge containing calcium chloride. The sponge dissolves while carrying out its hemostatic effect. Superstat® is a sterile, non-pyrogenic, nonantigenic product supplied in 1.5% or 3.0% concentrations

Action
Superstat® in contact with blood activates the coagulation mechanism. Clinical valuation has revealed no evidence of disseminated intra-vascular coagulation or local blood vessel coagulation. Dissolved Superstat® has been shown in vitro to have no effect on activated partial thromboplastin times and has been shown to have no platelet aggregating effects.
Animal studies demonstrate that Superstat® produces no foreign body response when left in situ.

Indications
Superstat® is indicated for use when hemostasis is desired along suture lines in diffusely bleeding sites, incisions, dissections, and around arterial or venous anastomoses. It is not intended to replace surgical ligature. Superstat® is indicated in oozing bleeding, either capillary or venous, in practically all incisions or wounds and as an adjunct to conventional closure techniques.

Contraindications
Superstat® is contraindicated in neurosurgical applications because no investigations on the effect of Superstat® on neurological tissue have been carried out to date. Superstat® is also contraindicated in instances of pumping arterial hemorrhage.

Directions for use
The pad can be used in whole or in part to produce hemostasis at the point of bleeding. Superstat® should be applied dry to the bleeding site and covered with a sterile laparotomy pad or gauze sponge. The material will begin to soften as it is applied. Hemostasis should occur within two or three minutes after application. If hemostasis is not complete, a second application of Superstat® should be used. Superstat® will dissolve at the bleeding site. It is not necessary to remove excess material. Residual clotted blood can be removed without causing further bleeding. Store Superstat® at controlled room temperature.

Precautions
In more profuse bleeding in which complete hemostasis is not observed, use of conventional surgical techniques may be necessary. Superstat® does not replace conventional surgical techniques such a clamping and/or ligation for severe bleeding. The use of Superstat® in patients with coagulopathies has not been fully evaluated. The effect of Superstat® used during pregnancy or its teratogenic potential have not been investigated.

Warning
Superstat® must be kept dry, moisture will cause Superstat® to lose its activity. Do not use Superstat® in instances of pumping arterial hemorrhage. Do not use Superstat® where blood or other fluids have pooled or in cases where the point of hemorrhage is submerged. Superstat® will not act as a tampon or permanent plug in bleeding site nor will it close off an area of blood collecting behind the tampon.

Discard unused portions of Superstat®.

Do not resterilize Superstat®.

Adverse Effects
Superstat® has shown no adverse effects on wound healing. There are no known toxic effects. The incidence rate of adhesion formation has not been investigated.