PORCINE COLLAGEN COMPOSITIONS AND METHODS OF USE THEREOF
The present disclosure provides compositions and methods related to wound management. The compositions include a micronized extracellular matrix and in some instances one or more antimicrobial agents. In some embodiments, the extracellular matrix is comprised of a porcine purified collagen wound matrix (CWM) and polyhexamethylene biguanide (PHMB). The composition is formulated as a powder and may be applied to a wound as a powder, or hydrated and applied to a wounds as a paste or a slurry.
1 .- 34 . (canceled)
35 . A paste comprising sterilized micronized particles of a Collagen Wound Matrix (CWM) having a micronized average particle size of 100 to 1000 micrometers (μm) in diameter, wherein the micronized particles comprise greater than 95% (w/w) native porcine Type I collagen, and wherein the paste is for application to a wound or site of injury.
36 . The paste of claim 35 , wherein the paste is a water-based paste.
37 . The paste of claim 35 , wherein the paste is a non-aqueous paste.
38 . The paste of claim 36 , wherein the water-based paste is an isotonic paste.
39 . The paste of claim 38 , wherein the isotonic paste has a salt concentration of about 0.15 molar (M).
40 . The paste of claim 38 , wherein the isotonic paste comprises phosphate buffered saline (PBS).
41 . The paste of claim 35 , wherein the paste has a viscosity of at least 1.5 pascal-second (P·s).
42 . The paste of claim 41 , wherein the paste has a viscosity of at least 10 P·s.
43 . The paste of claim 35 , wherein the paste further comprises whole blood or platelet-rich plasma.
44 . The paste of claim 35 , wherein the sterilized micronized collagen particles have been sterilized by gamma irradiation.
45 . The paste of claim 35 , wherein the native porcine Type I collagen is free of cells and cell remnants.
46 . The paste of claim 35 , wherein the paste further comprises an antimicrobial agent, optionally wherein the antimicrobial agent is a cationic antimicrobial agent selected from the group consisting of a quaternary ammonium compound, a bisbiguanide, and a polymeric biguanide.
47 . A method of manufacturing a micronized collagen composition comprising micronized particles of a Collagen Wound Matrix (CWM), the method comprising the steps of:
generating intestinal collagen layers (ICLs) from the small intestine of a pig;
chemically cleaning the ICLs to produce chemically-cleaned ICLs;
drying the chemically-cleaned ICLs to produce dried, chemically-cleaned ICLs;
and milling the dried, chemically-cleaned ICLs to produce a micronized collagen composition comprising micronized particles of a CWM,
wherein the micronized particles have a micronized average particle size of 100 to 1000 micrometers (μm) in diameter, wherein the micronized particles comprise greater than 95% (w/w) native porcine Type I collagen, and wherein the micronized collagen composition is for application to a wound or site of injury.
48 . The method of claim 47 , further comprising irradiating the micronized collagen composition with gamma rays.
49 . The method of claim 47 , wherein the generating ICLs comprises trimming the small intestine into intestinal sheets; and mechanically removing inner and outer mucosal layers from the intestinal sheets to form the intestinal collagen layers (ICLs).
50 . The method of claim 47 , wherein the chemically cleaning comprises incubating the intestinal collagen layers (ICLs) at a pH of 11 to 12, followed by incubating at a pH of 0 to 1, followed by incubating at a pH of 7 to 7.4 in phosphate buffered saline (PBS).
51 . The method of claim 47 , further comprising packaging the micronized collagen composition into one or more single-use packages.
52 . The method of claim 51 , wherein each of the one or more single-use packages contains 100 milligrams (mg), 500 mg, or 1000 mg of the micronized collagen composition.
53 . The method of claim 47 , further comprising mixing the micronized collagen composition with phosphate buffered saline (PBS) to form a paste.