Preparation of a skin surface for a surgical procedure

Claim 2

A film forming composition for surgical site preparation on a skin surface comprising: a fugitive solvent; a film forming material soluble in said solvent; an antimicrobial agent soluble in said solvent capable of being releasably retained in said film forming material; means for providing color change indicating an area of the skin surface covered by said composition, said color change further indicating substantial elimination of said fugitive solvent from said composition after said composition is applied to the skin surface; and said film forming material and said antimicrobial agent when applied to the skin surface from said fugitive solvent, forming a substantially water insoluble, substantially tack-free flexible film adherent to the skin surface, said film capable of releasing said antimicrobial agent in a quantity sufficient to substantially inhibit microbial growth on the skin surface.

Claim 3

The composition of claim 1 further comprising a plasticizing agent for increasing the flexibility of said film.

Claim 4

The composition of claim 1 wherein said indicating means comprises at least one compound having a first color for providing a visual indication of the area of skin surface covered and a second color when said fugitive solvent is substantially eliminated, thereby providing a visual indication that said film is dry and the surgical site is ready.

Claim 5

The composition of claim 3 wherein said indicating means comprises orthophenyl phenol, sodium salt, and a quantity of a dye selected from the group consisting of Food Drug and Cosmetic Red No. 40 and Drug and Cosmetic Red No. 17, sufficient to provide a purple color on the skin surface when said fugitive solvent is present and a red color on the skin surface when said fugitive solvent is substantially eliminated.

Claim 6

The composition of claim 1 wherein said antimicrobial agent is present in a quantity sufficient to substantially inhibit microbial growth on the surface of skin, said agent being selected from the group consisting of iodophors, chlorophenols, biguanides, antibiotics and biologically active salts thereof.

Claim 7

The composition of claim 6 wherein said antimicrobial agent is chlorhexidine diacetate present in a quantity ranging between about 0.5 to about 10 parts per one hundred parts (weight/weight).

Claim 8

A film forming composition for surgical site preparation on a skin surface comprising: a fugitive solvent; a film forming material soluble in said solvent; an antimicrobial agent soluble in said solvent capable of being releasably retained in said film forming material; means for indicating an area of the skin surface being covered by said composition and for indicating substantial elimination of said fugitive solvent from said composition afer said composition is applied to the skin surface; and said composition forming a substantially tack-free, substantially water insoluble, flexible film adherent to the skin surface, said film having a first color when said solvent is present thereby indicating the covered area of the skin surface and a second color when said solvent is substantially eliminated, thereby providing an indication that said film is dry and the surgical site is ready.

Claim 9

A film forming composition for surgical site preparation on a skin surface comprising: a fugitive solvent; a film forming material soluble in said solvent; an antimicrobial agent soluble in said solvent capable of being releasably retained in said film forming material; means for indicating an area of the skin surface being covered by said composition and for indicating substantial elimination of said fugitive solvent from said composition afer said composition is applied to the skin surface; and said composition forming a substantially tack-free, substantially water insoluble, flexible film adherent to the skin surface, said film having a first color when said solvent is present thereby indicating the covered area of the skin surface and a second color when said solvent is substantially eliminated, thereby providing an indication that said film is dry and the surgical site is ready.

Claim 10

The composition of claim 7 wherein said fugitive solvent is selected from the group consisting of isopropanol, ethanol, ethylene dichloride, acetone, ethyl acetate and 1,1,2-trichlorotrifluoroethane.

Claim 11

The composition of claim 7 wherein said film forming material is selected from the group consisting of ethyl cellulose, methoxy cellulose, hydroxyethyl cellulose, polyvinyl pyrrolidone, vinyl acetate, and cross linked pyrrolidone.

Claim 12

The composition of claim 7 wherein said film forming material is ethyl cellulose having an ethoxy content between about 45 percent to about 55 percent (weight/weight).

Claim 13

The composition of claim 7 further comprising a plasticizing agent for increasing the flexibility of said film selected from the group consisting of polyethylene glycol, polyoxypropylene glycol, polyoxyethylenepropylene glycol, glycerin, polyoxyethylene-polyoxypropylene block copolymers, cottonseed oil, palm oil, rapeseed oil, sunflower oil, castor oil and poly(tetrahydrofuran).

Claim 14

The composition of claim 7 wherein said antimicrobial agent is present in a quantity sufficient to substantially inhibit microbial growth on the surface of the skin and is selected from the group consisting of iodophors, chlorophenols, biguanides, antibiotics and biologically active salts thereof.

Claim 15

The composition of claim 7 wherein said indicating means comprises orthophenylphenol, sodium salt, and a quantity of a dye selected from the group Food, Drug and Cosmetic Red No. 40 and Drug and Cosmetic Red No. 17, sufficient to provide a purple color on the skin surface when said fugitive solvent is present and a red color on the skin surface when said fugitive solvent is substantially eliminated.

Claim 18

The method of claim 14 further comprising observing a first color indicating the site having said composition applied thereon and observing a second color after said allowing step thereby indicating said substantial elimination of said fugitive solvent.

Claim 19

A film forming composition for preparing skin as a site for a surgical procedure comprising a homogeneous solution of: ______________________________________ Amount (Parts/Hundred, Ingredient {wt./wt.}) ______________________________________ propylene glycol methyl ether about 10 to about 50 ethyl cellulose about 2.5 to about 4.5 polyoxypropylene glycol about 2 to about 4 Drug and Cosmetic red no. 17 about 0.001 to about 0.015 orthophenyl phenol, sodium salt about 0.1 to about 1.0 chlorhexidine diacetate about 0.5 to about 10 isopropyl alcohol quantity sufficient to make 100 parts; ______________________________________ said composition for application to a skin surface from said isopropyl alcohol as a fugitive solvent; said ethyl cellulose, propylene glycol methyl ether and polyoxypropylene glycol forming a skin adherent flexible film capable of releasably containing said chlorhexidine diacetate as an antimicrobial agent, thereby forming a substantially water insoluble, substantially tack-free flexible film; said Drug and Cosmetic red No. 17 and said orthophenyl phenol, sodium salt, providing said composition a first color indicating an area of the skin surface covered and a second color indicating substantial elimination of said fugitive solvent after said composition is applied to the skin surface; and said antimicrobial agent being releaseably retained in said film and capable of being released in a quantity sufficient for substantially inhibiting microbial growth on the skin surface.

Claim 20

A film forming composition for preparing skin as a site for a surgical procedure comprising a homogeneous solution of: ______________________________________ Amount (Parts/Hundred, Ingredient {wt./wt.}) ______________________________________ propylene glycol methyl ether about 10 to about 50 ethyl cellulose about 2.5 to about 4.5 polyoxypropylene glycol about 2 to about 4 Drug and Cosmetic red no. 17 about 0.001 to about 0.015 orthophenyl phenol, sodium salt about 0.1 to about 1.0 chlorhexidine diacetate about 0.5 to about 10 isopropyl alcohol quantity sufficient to make 100 parts; ______________________________________ said composition for application to a skin surface from said isopropyl alcohol as a fugitive solvent; said ethyl cellulose, propylene glycol methyl ether and polyoxypropylene glycol forming a skin adherent flexible film capable of releasably containing said chlorhexidine diacetate as an antimicrobial agent, thereby forming a substantially water insoluble, substantially tack-free flexible film; said Drug and Cosmetic red No. 17 and said orthophenyl phenol, sodium salt, providing said composition a first color indicating an area of the skin surface covered and a second color indicating substantial elimination of said fugitive solvent after said composition is applied to the skin surface; and said antimicrobial agent being releaseably retained in said film and capable of being released in a quantity sufficient for substantially inhibiting microbial growth on the skin surface.

Claim 21

A kit for preparing a skin surface site for a surgical procedure comprising: a sealed unit container for containing the film forming composition of claim 1 means for applying said film forming composition to a skin surface; and a package holding said sealed unit container and said means for applying.

Claim 22

The kit of claim 17 wherein said film forming composition comprises ethyl cellulose, propylene glycol methyl ether, polyoxypropylene glycol, chlorhexidine diacetate and isopropyl alcohol.

Claim 23

The kit of claim 18 wherein said film forming composition further comprises sufficient orthophenyl phenol, sodium salt, and Drug and Cosmetic red no. 17 to provide a purple color on the skin surface when said fugitive solvent is present and a red color on the skin surface when said fugitive solvent is substantially eliminated.

Claim 24

The kit of claim 17 wherein said sealed unit container and said package are non-resealable after opening, thereby providing a single-use procedure kit for surgical site preparation.