Gelfilm (Absorbable Gelatin Film)

GELFILM®

Pharmacia & Upjohn

Absorbable Gelatin Film

Surgical Implant

Description: Gelfilm Sterile Film and Gelfilm Sterile Ophthalmic Film are absorbable gelatin film approximately 0.075 mm in thickness, designed for use as an absorbable gelatin implant in neurosurgery and thoracic and ocular surgery.

In the dry state absorbable gelatin film has the appearance and texture of cellophane of equivalent thickness; when moistened, it assumes a rubbery consistency and can be cut to desired size and shape and fitted to rounded or irregular surfaces.

Action And Clinical Pharmacology: Rate of absorption of absorbable gelatin after implantation ranges from 1 to 6 months depending on size of the implant and site of implantation. Pleural and muscle implants have been reported to be completely absorbed in eight to 14 days, whereas dural and ocular implants usually require at least 2 to 5 months for absorption. Absence of undue tissue reaction incident to implantation and absorption of absorbable gelatin film, with consequent decreased likelihood of developing adhesions, has been found to be of particular value in dural and ocular implants.

Indications And Clinical Uses: Neurosurgery: Nonconducive to undue inflammatory reaction and absorbable at a rate sufficiently slow to permit dural regeneration and healing of the arachnoid layer, absorbable gelatin favorably meets requisites for a dural substitute. Use in patients undergoing craniotomies has been reported to prevent development of meningocerebral adhesions and thereby reduce risk of postoperative sequelae.

Thoracic Surgery: In repair of pleural defects in connection with thoracotomies, thoracoplasties, and extrapleural procedures, implantation of absorbable gelatin film has been observed to be followed by minimal tissue reaction and closure of the defect by ingrowth of regenerating pleural and fibrous tissue across the gradually resorbed gelatin film implant.

Ocular Surgery: Various ocular surgical procedures in which absorbable gelatin sterile ophthalmic film has been used include glaucoma filtration operations (i.e., iridencleisis and trephination), extraocular muscle surgery, and diathermy or scleral “buckling” operations for retinal detachment. Experimental studies in rabbits and clinical trials in patients have shown a remarkable lack of cellular reaction to absorbable gelatin film implanted subconjunctivally or used as a seton into the anterior chamber. Objective evidence that absorbable gelatin implants aid in preventing formation of adhesions between contiguous ocular structures has been reported as follows: in iridencleisis in which absorbable gelatin was employed as a seton, the resultant filtrating areas were large and there was no postoperative rise in intraocular tension; in extraocular muscle surgery and operations for retinal detachment, insertion of absorbable gelatin implants between contiguous tissue layers was found to enhance the ease of secondary operations.

Contra-Indications: None known.

Precautions: Because the rate of absorption of absorbable gelatin sterile film and absorbable gelatin sterile ophthalmic film is likely to be increased in presence of purulent exudation, it is recommended that absorbable gelatin film not be implanted in grossly contaminated or infected surgical wounds.

Dosage And Administration: Directions for Use: To prepare for use, immerse absorbable gelatin film in sterile saline solution and allow it to soak until it becomes quite pliable; it may then be cut to desired size and shape without difficulty and applied as follows:

For covering dural defects, absorbable gelatin sterile film is placed over the surface of the brain, the edges of the implant tucked beneath the dura and the wound then closed in the usual manner. If desired, the absorbable gelatin film can be sutured loosely to the dura. Care must be exercised, however, because moist film tears easily. For covering pleural defects, absorbable gelatin sterile film is placed over the defect and anchored in place by small interrupted sutures.

For use as a seton in iridencleisis, a small piece of absorbable gelatin sterile ophthalmic film (approximately 4´10 mm) is placed over the prolapsed iris pillar parallel to the limbus; Tenon’s capsule and the conjunctiva are then closed with continuous absorbable sutures spaced to insure tight closure. In diathermy or scleral “buckling” operations, absorbable gelatin sterile ophthalmic film may be placed over the sclera, the muscle and the conjunctiva then sutured over the underlying absorbable gelatin film. In extraocular muscle surgery, absorbable gelatin sterile ophthalmic film may be placed over and beneath the muscle before Tenon’s capsule and the conjunctiva are closed in layers.

Availability And Storage: Sterile Film: For use in neurosurgery and thoracic surgery, approximately 0.075 mm in thickness, size 125 sq cm (10´12.5 cm). Sterile envelopes, cartons of one.

Sterile Ophthalmic Film: For use in ocular surgery, approximately 0.075 mm in thickness, size 12.5 sq cm (2.5´5 cm). Sterile envelopes, cartons of 6.

Store at controlled room temperature 15 to 30°C. Once the envelopes have been opened, contents are subject to contamination. To insure sterility, it is recommended that absorbable gelatin film be used immediately after withdrawal from the envelope.

GELFILM® Pharmacia & Upjohn Absorbable Gelatin Film Surgical Implant Description: Gelfilm Sterile Film and Gelfilm Sterile Ophthalmic Film are absorbable gelatin film approximately 0.075 mm in thickness, designed for use as an absorbable gelatin implant in neurosurgery and thoracic and ocular surgery. In the dry state absorbable gelatin film has the appearance and texture of cellophane of equivalent thickness; when moistened, it assumes a rubbery consistency and can be cut to desired size and shape and fitted to rounded or irregular surfaces.

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