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.
ACTIONS
Rate of absorption of GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film
after implantation ranges from one to six 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 two to five 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 USAGE
Neurosurgery: Nonconducive to undue inflammatory reaction and absorbable at a
rate sufficiently slow to permit dural regeneration and healing of the arachnoid layer,
GELFILM Sterile Film 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 GELFILM Sterile 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
GELFILM implant.
Ocular Surgery: Various ocular surgical procedures in which GELFILM 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
GELFILM implanted subconjunctivally or used as a seton into the anterior chamber.
Objective evidence that GELFILM implants aid in preventing formation of adhesions
between contiguous ocular structures has been reported as follows: in iridencleisis in
which GELFILM 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 GELFILM implants
between contiguous tissue layers was found to enhance the ease of secondary
operations.
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, GELFILM 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 GELFILM can be sutured loosely to the dura. Care
must be exercised, however, because moist film tears easily. For covering pleural
defects, GELFILM 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 GELFILM Sterile Ophthalmic
Film (approximately 4 x 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, GELFILM Sterile Ophthalmic Film
may be placed over the sclera, the muscle and the conjunctiva then sutured over the
underlying GELFILM.
In extraocular muscle surgery, GELFILM Sterile Ophthalmic Film may be placed
over and beneath the muscle before Tenon's capsule and the conjunctiva are closed in
layers.
CONTRAINDICATIONS
Do not use GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film in patients
with known allergies to porcine collagen.
PRECAUTIONS
Because the rate of absorption of GELFILM Sterile Film and GELFILM 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.
HOW SUPPLIED
GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film are supplied in the
following packages:
GELFILM Sterile Film, for use in neurosurgery and thoracic surgery, sterile
envelopes, one per carton, GTIN 00300090283018 (0009-0283-01).
GELFILM Sterile Ophthalmic Film, for use in ocular surgery, sterile envelopes, six
per carton, GTIN 00300090297039 (0009-0297-03).
STORAGE AND HANDLING
GELFILM Sterile Film and GELFILM Sterile Ophthalmic Film should be stored at
25�C (77�F); excursions permitted to 15-30�C (59-86�F) [see USP Controlled Room
Temperature]. 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.
