ENGINEERED SKIN CONSTRUCT OVERLAY OF AUTOGRAFT
The present disclosure provides methods for treating wounds by applying a meshed autograft and skin substitute overlay wherein the skin substitute is an organotypic human skin equivalent comprising NIKS® cells.
1 . A method for treating a full-thickness wound in a subject, the method comprising applying to the wound an autograft with a mesh ratio of about 2:1 to about 8:1 (“treatment autograft”) and a skin substitute overlay, wherein the skin substitute is an organotypic human skin equivalent comprising NIKS cells.
2 . A method for obtaining closure of a full-thickness wound in a subject, the method comprising applying to the wound an autograft with a mesh ratio of about 2:1 to about 8:1 (“treatment autograft”) and a skin substitute overlay, wherein the skin substitute is an organotypic human skin equivalent comprising NIKS cell and wherein wound closure is about 90% re-epithelialization or greater.
3 . The method of claim 2 , wherein wound closure occurs within about 12 weeks of initial application of the skin substitute.
4 - 6 . (canceled)
7 . The method of claim 2 , wherein wound closure is about 95% re-epithelialization or greater.
8 - 9 . (canceled)
10 . The method of claim 7 , wherein wound closure is complete wound closure.
11 . The method of claim 7 , wherein wound closure is durable wound closure.
12 . The method of claim 2 , wherein the closed wound has comparable or improved vascularity, comparable or improved pigmentation, comparable or decreased thickness, comparable or decreased pain, comparable or increased pliability, comparable or increased scarring surface area, comparable or decreased stiffness, comparable or decreased itching, comparable or improved color, or any combination thereof, as assessed by an observer or by the subject, as compared to a comparable wound treated with autograft alone (“comparator autograft”), wherein the comparator autograft has a mesh ratio that is the same or less than the treatment autograft.
13 . A method for improving an outcome of wound healing in a subject, the method comprising: applying to a full-thickness wound of a subject an autograft with a mesh ratio of about 2:1 to about 8:1 (“treatment autograft”) and a skin substitute overlay, wherein the skin substitute is an organotypic human skin equivalent comprising NIKS cells;
wherein the improved outcome is a reduction in the incidence of autografting, decreased donor skin utilization, decreased pain, an improvement in one or more cosmetic quality of the closed wound, decreased treatment associated adverse events, decreased infection rate, decreased wound-infection related events, decreased donor-site morbidities, reduced health care resource utilization, improved quality of life, or combinations thereof, as measured by an observer or by the subject in comparison to a comparable wound treated with autograft alone (“comparator autograft”), wherein the comparator autograft has a mesh ratio that is the same or less than the treatment autograft.
14 . The method of claim 13 , wherein the improvement is statistically significant.
15 . The method of claim 13 , wherein the comparator autograft has a mesh ratio less than the treatment autograft.
16 . The method of claim 1 , wherein the treatment autograft has a mesh ratio of about 3:1 to about 8:1.
17 - 18 . (canceled)
19 . The method of claim 1 , wherein the treatment autograft has a mesh ratio of about 2:1 to about 6:1.
20 . (canceled)
21 . The method of claim 1 , wherein there is only a single application of the skin substitute to the wound.
22 . The method of claim 1 , wherein there is only a single application of the treatment autograft to the wound.
23 . The method of claim 1 , wherein the wound is a burn wound.
24 . The method of claim 23 , wherein the wound is an electrical burn wound, a chemical burn wound, or a thermal burn wound.
25 . The method of claim 1 , wherein the subject has a total wound area covering up to about 85% total body surface area (TBSA), the total wound area comprising the area of the wound.
26 . The method of claim 25 , wherein the subject has a full thickness % TBSA of about 10% to about 60%.
27 . (canceled)
28 . The method of claim 25 , wherein the method further comprises applying the treatment autograft and the skin substitute overlay to a plurality of wounds.
29 . The method of claim 1 , wherein the skin substitute comprises a dermal equivalent, the dermal equivalent comprising gelled collagen containing normal human dermal fibroblasts.
30 . The method of claim 29 , wherein the collagen present in the dermal equivalent comprises type I murine collagen.
31 . The method of claim 29 , wherein the only collagen in the dermal equivalent is produced by cells of the skin substitute.
32 . The method of claim 1 , wherein the wound is clinically indicated for excision and grafting.
33 - 39 . (canceled)
40 . The method of claim 1 , wherein the treatment autograft and the skin substitute are applied to a surface area of less than 200 cm 2 .
41 . The method of claim 1 , wherein the treatment autograft and the skin substitute are applied to a surface area about 100 cm 2 or greater.
42 - 44 . (canceled)
45 . The method of claim 41 , wherein the treatment autograft and the skin substitute are applied to a surface area of about 100 cm 2 to about 10,000 cm 2 .
46 . (canceled)
47 . The method of claim 1 , wherein the organotypic human skin equivalent comprising NIKS has a mesh ratio of about 1:1.