Birth tissue compositions and methods of preparation

1 . A method of treating a wound, the method comprising the step of:

introducing a birth tissue composition on or around the wound,

wherein the birth tissue composition comprises a dehydrated, decellularized porcine placental membrane that is prepared by a method comprising:

(i) a bioburden reduction step comprising contacting unprocessed porcine placental membrane with a 3M sodium chloride solution at about 20 mL per gram of porcine placental membrane for about 30 minutes to about 2 hours to reduce microbial load and form a bioburden reduced porcine placental membrane;

(ii) decanting the sodium chloride solution;

(iii) rinsing the sodium chloride solution from the bioburden reduced porcine placental membrane with water;

(iv) a detergent rinse step comprising contacting the bioburden reduced porcine placental membrane after step (iii) with a detergent solution comprising at least one anionic detergent and at least one protease enzyme, wherein the anionic detergent is present at a concentration of about 0.25% to about 3% w/v, wherein the contacting occurs for about one hour to about three hours, for removal of cellular debris while preserving extracellular matrix integrity; and

(v) decanting the detergent solution to form a detergent rinsed porcine placental membrane;

(vi) rinsing the detergent solution from the detergent rinsed porcine placental membrane with water;

(vii) a viral inactivation step comprising immersing the rinsed porcine placental membrane after step (vi) in a sodium hydroxide solution at a concentration of about 0.25M for about 15 minutes to about 45 minutes to form a viral inactivated porcine placental membrane;

(viii) rinsing the sodium hydroxide solution from the viral inactivated porcine placental membrane with water;

(ix) introducing from about 5 mL to about 50 mL of buffer solution per gram of porcine placental membrane to the rinsed porcine placental membrane after step (viii);

(x) decanting the buffer solution;

(xi) measuring the pH of the porcine placental membrane after step (x);

(xii) repeating steps (ix)-(xi) until the pH of the porcine placental membrane is between about 6.8 and about 7.2;

(xiii) rinsing the buffer solution from the porcine placental membrane after step (xii) with water; and

(xiv) dehydrating the porcine placental membrane after (xiii) to form the dehydrated, decellularized porcine placental membrane,

wherein the dehydrated, decellularized porcine placental membrane exhibits a final pH of between about 6.8 and about 7.2, and

wherein the dehydrated, decellularized porcine placental membrane retains collagen I, collagen IV, elastin, laminin, fibronectin, and hyaluronic acid.

2 . The method of claim 1 , wherein the wound is selected from the group consisting of a burn, cut, abrasion, and ulcer.

3 . The method of claim 1 , wherein the wound is a partial-thickness wound, full-thickness wound, pressure ulcer, venous ulcer, diabetic ulcer, chronic vascular ulcer, tunneled/undermined wound, surgical wound, trauma wound, or draining wound.

4 . The method of claim 3 , wherein the wound is located anywhere in or on a mammalian body.

5 . The method of claim 1 , wherein the birth tissue composition is held in place by one or more sutures or staples.

6 . The method of claim 1 , further comprising the step of hydrating the birth tissue composition after introduction to the wound.

7 . The method of claim 1 , wherein the birth tissue composition further comprises at least one antibiotic, anti-inflammatory agent, growth factor, or a combination thereof.

8 . The method of claim 1 , wherein the birth tissue composition is combined with a substrate.

9 . The method of claim 8 , wherein the substrate comprises at least one sterile gauze, sterile polymer material, biomaterial, or a combination thereof.

10 . The method of claim 1 , wherein the birth tissue composition is held in place by musculature or skin.

11 . The method of claim 1 , wherein the birth tissue composition is placed over an implant or device.

12 . The method of claim 1 , wherein the birth tissue composition covers an implant or other device placed on or within a mammalian body.

13 . The method of claim 1 , wherein step (i) is performed for about one hour.

14 . The method of claim 1 , wherein in step (iv) the detergent solution comprises sodium linear alkylaryl sulfonate, phosphates, carbonates, and at least one protease enzyme.

15 . The method of claim 1 , wherein in step (iv) the anionic detergent is present at a concentration of about 1% w/v.

16 . The method of claim 1 , wherein step (vii) is performed for about 20 minutes.

17 . The method of claim 1 , wherein in step (ix) the buffer solution is phosphate-buffered saline.

18 . The method of claim 1 , wherein step (xiv) comprises contacting the porcine placental membrane with 200 proof ethanol.