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 . A sterilized micronized collagen composition for use in wound management, the composition comprising micronized particles of a Collagen Wound Matrix (CWM) having a micronized average particle size of 100 to 1000 micrometers (um) in diameter, wherein the composition comprises greater than 95% (w/w) native porcine Type I collagen, wherein the micronized particles are flakes, wherein the composition is for application to a wound, wherein the wound is an irregularly shaped wound or a tunneling wound, and wherein the micronized size of the composition allows direct contact to the entirety of the bed of the wound.
2 . The composition of claim 1 , wherein the native porcine Type I collagen is free of cells and cell remnants.
3 . The composition of claim 1 , wherein the CWM has a denaturation temperature determined by differential scanning calorimetry (DSC) of ≥45° C.
4 . The composition of claim 1 , wherein the composition comprises less than 0.7% (w/w) lipids and less than 1.0% (w/w) glycosaminoglycans.
5 . The composition of claim 1 , wherein the composition comprises less than 0.1 nanograms per milliliter (ng/ml) DNA.
6 . The composition of claim 1 , wherein the composition is sterilized by gamma irradiation.
7 . The composition of claim 1 , wherein the CWM is cross-linked.
8 . The composition of claim 1 , wherein the composition further comprises an antimicrobial agent.
9 . The composition of claim 8 , 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.
10 . The composition of claim 9 , wherein the cationic antimicrobial agent is selected from the group consisting of benzalkonium chloride, cetrimide, chlorhexidine, a chlorhexidine salt, polyhexamethylene biguanide (PHMB), a PHMB salt, polyaminopropyl biguanide (PAPB), a PAPB salt, and any combination thereof.
11 . The composition of claim 1 , wherein the micronized particles further comprise a polyaminopropyl biguanide coating.
12 . The composition of claim 11 , wherein the polyaminopropyl biguanide coating comprises polyhexamethylene biguanide (PHMB) present at a concentration selected from the group consisting of less than 0.05% by weight (w/w), between 0.001% and 0.045% (w/w), and between 0.01% and 0.02% (w/w).
13 . The composition of claim 1 , wherein the micronized particles are wet particles, and wherein the composition further comprises a sterile solution.
14 . The composition of claim 1 , wherein the composition comprises less than 25 endotoxin units (EU) per 100 milligrams (mg) of micronized particles.
15 . The composition of claim 1 , wherein the composition further comprises petrolatum or an oil-based carrier.
16 . A method for managing a wound in a subject in need thereof comprising
cleaning the wound of debris and necrotic tissue; and
applying a sterilized micronized collagen composition to the entire area of the wound, wherein the composition comprises micronized particles of a Collagen Wound Matrix (CWM) having a micronized average particle size of 1000 micrometers (um) or less in diameter, wherein the composition comprises greater than 95% (w/w) native porcine Type I collagen, wherein the micronized particles are flakes, wherein the wound is an irregularly shaped wound or a tunneling wound, and wherein the micronized size of the composition allows direct contact to the entirety of the bed of the wound.
17 . The method of claim 16 , further comprising hydrating the composition with sterile saline solution or a biological fluid selected from amniotic suspension, blood, bone marrow aspirate, or platelet rich plasma, to form a paste.
18 . A sterilized micronized collagen composition for use in the manufacture of a medicament for wound management, the composition comprising micronized particles of a Collagen Wound Matrix (CWM) having a micronized average particle size of 100 to 1000 micrometers (μm) in diameter, wherein the composition comprises greater than 95% (w/w) native porcine Type I collagen, less than 0.7% (w/w) lipids, less than 1.0% (w/w) glycosaminoglycans, and less than 0.1 nanograms per milliliter (ng/ml) DNA, wherein the native porcine Type I collagen is free of cells and cell remnants, wherein the micronized particles are flakes, wherein the composition is for application to a wound, wherein the wound is an irregularly shaped wound or a tunneling wound selected from the group consisting of a partial thickness wound, a full-thickness wound, a pressure ulcer, a venous ulcer, a diabetic ulcer, a chronic vascular ulcer, a tunneled wound, an undermined wound, a surgical wound, wound dehiscence, a trauma wound, a second degree burn, and a draining wound, and wherein the micronized size of the composition allows direct contact to the entirety of the bed of the wound.
19 . The method of claim 16 , wherein the irregularly shaped wound or tunneling wound is selected from the group consisting of a partial thickness wound, a full-thickness wound, a pressure ulcer, a venous ulcer, a diabetic ulcer, a chronic vascular ulcer, a tunneled wound, an undermined wound, a surgical wound, wound dehiscence, a trauma wound, a second degree burn, and a draining wound.
20 . The method of claim 16 , wherein the composition is applied to the wound once weekly until the wound has healed.
21 . A sterilized and packaged micronized collagen powder device for use in wound management, the device comprising micronized particles of a Collagen Wound Matrix (CWM) having a micronized average particle size of 100 to 1000 micrometers (μm) in diameter, wherein the device comprises greater than 95% (w/w) native porcine Type I collagen, wherein the micronized particles are flakes, wherein the device is for application to a wound, wherein the wound is an irregularly shaped wound or a tunneling wound, wherein the micronized size of the device allows direct contact to the entirety of the bed of the wound, and wherein the device is situated within one or more packages.
22 . The device of claim 21 , wherein each of the one or more packages is a single use package.
23 . The device of claim 21 , wherein each of the one or more packages comprises 100 milligrams (mg), 500 mg, or 1000 mg of the device.