SOLID DRESSING FOR TREATING WOUNDED TISSUE
Disclosed are solid dressings for treated wounded tissue in mammalian patients, such as a human, comprising a haemostatic layer consisting essentially of fibrinogen and a fibrinogen activator, wherein the fibrinogen is present in an amount between 3.0 mg/cm 2 of the wound facing surface of the dressing and 13.0 mg/cm 2 of the wound facing surface of the dressing. Also disclosed are methods for treating wounded tissue.
1 . A solid dressing for treating wounded tissue m a mammal comprising at least one haemostatic layer consisting essentially of fibrinogen and a fibrinogen activator, wherein said fibrinogen is present in an amount between 3.0 mg/cm 2 of the wound facing surface of said dressing and 13.0 mg/cm 2 of the wound facing surface of said dressing.
2 . The solid dressing of claim 1 , further comprising at least one support layer.
3 . The solid dressing of claim 2 , wherein said support layer comprises a backing material.
4 . The solid dressing of claim 2 , wherein said support layer comprises an internal support material.
5 . The solid dressing of claim 2 , wherein said support layer comprises a resorbable material.
6 . The solid dressing of claim 2 , wherein said support layer comprises a non-resorbable material.
7 . (canceled)
8 . The solid dressing of claim 3 , further comprising at least physiologically acceptable adhesive between said haemostatic layer and said backing layer.
9 - 11 . (canceled)
12 . The solid dressing of claim 1 , wherein said haemostatic layer also contains a fibrin crosslinker and/or a source of calcium ions.
13 . The solid dressing of claim 1 , wherein said haemostatic layer also contains one or more of the following: at least one filler, at least one solubilizing agent, at least one foaming agent and at least one release agent.
14 - 17 . (canceled)
18 . The solid dressing of claim 1 , wherein said haemostatic layer also contains at least one therapeutic supplement selected from the group consisting of antibiotics, anticoagulants, steroids, cardiovascular drugs, growth factors, antibodies (poly and mono), chemoattractants, anesthetics, antiproliferatives/antitumor agents, antivirals, cytokines, colony stimulating factors, antifungals, antiparasitics, antiinflammatories, antiseptics, hormones, vitamins, glycoproteins, fibronectin, peptides, proteins, carbohydrates, proteoglycans, antiangiogenins, antigens, nucleotides, lipids, liposomes, fibrinolysis inhibitors and gene therapy reagents.
19 . The solid dressing of claim 1 , wherein said haemostatic layer is made from a single aqueous solution containing a mixture of said fibrinogen and said fibrinogen activator.
20 . The solid dressing of claim 1 , wherein said haemostatic layer is cast as a single piece.
21 . The solid dressing of claim 1 , wherein said haemostatic layer is substantially homogeneous throughout.
22 . The solid dressing of claim 1 , wherein said haemostatic layer is composed of a plurality of particles, each of said particles consisting essentially of fibrinogen and thrombin.
23 . The solid dressing of claim 22 , wherein said haemostatic layer further contains at least one binding agent in an amount effective to improve the adherence of said particles to one another.
24 . (canceled)
25 . The solid dressing of claim 1 , wherein said haemostatic layer is a monolith.
26 . The solid dressing of claim 1 , wherein said haemostatic layer has been lyophilized.
27 - 37 . (canceled)
38 . The solid dressing of claim 1 , wherein said fibrinogen activator is present in an amount between 2.50 Units/mg of fibrinogen component and 0.025 Units/mg of the fibrinogen.
39 . The solid dressing of claim 18 , wherein said therapeutic supplement is present in an amount equal to or greater than its solubility limit in fibrin.
40 . A method of treating wounded tissue in a mammal, comprising placing a solid dressing of claim 1 to said wounded tissue and applying sufficient pressure to said dressing for a sufficient time for enough fibrin to form to reduce the loss of blood and/or other fluid from said wounded tissue.