GEL-FLOW� NT
absorbable gelatin powder
Hemostatic Matrix for flowable applications (6 mL)
DESCRIPTION
The GEL-FLOW NT device consists of 550 mg of GELFOAM�
Sterile Powder
(absorbable gelatin powder from absorbable gelatin sponge, USP), a syringe delivery
system and two applicator tips for delivery of the flowable mixture to deep and
narrow administration sites. The components of the GEL-FLOW NT sterile flowable
delivery system are provided in an inner sterile pouch. GEL-FLOW NT is a medical
device intended for application to bleeding surfaces as a hemostatic. It is a waterinsoluble, off-white, nonelastic, porous, pliable product prepared from purified
porcine Skin Gelatin USP Granules and Water for Injection, USP and is able to
absorb and hold within its interstices, up to 45 times its weight of whole blood4
and
other fluids. The GELFOAM Sterile Powder used in GEL-FLOW NT is a fine, dry,
gamma sterilized light powder prepared by milling absorbable gelatin sponge.
ACTION
GEL-FLOW NT has hemostatic properties. While its mode of action is not fully
understood, its effect appears to be more physical than the result of altering the blood
clotting mechanism.
When not used in excessive amounts, GEL-FLOW NT is absorbed completely, with
little tissue reaction. This absorption is dependent on several factors, including the
amount used, degree of saturation with blood or other fluids, and the site of use. When
placed in soft tissues, GEL-FLOW NT is usually absorbed completely in four to six
weeks, without inducing excessive scar tissue. When applied to bleeding nasal, rectal
or vaginal mucosa, it liquefies within two to five days.
INDICATIONS
Hemostasis: GEL-FLOW NT is indicated in surgical procedures, including those
involving cancellous bone bleeding, as a hemostatic device, when control of capillary,
venous, and arteriolar bleeding by pressure, ligature, and other conventional
procedures is either ineffective or impractical. Although not necessary,
GEL-FLOW NT can be used either with or without thrombin to obtain hemostasis.
DIRECTIONS FOR USE
GEL-FLOW NT must be saturated with sterile, isotonic sodium chloride solution
(sterile saline) or a sterile solution of thrombin*
, before use as an adjunct to
hemostasis.
GEL-FLOW NT is provided as 550 mg Gelfoam Sterile Powder pre-packaged in a
10 mL syringe for hydration.
*
Prepare thrombin solution per instructions in product prescribing information.
Before Use:
Inspect the GEL-FLOW NT package for signs of damage. If the package is torn or
punctured, GEL-FLOW NT should not be used. To prevent contamination, employ
aseptic procedure in opening package and removing the GEL-FLOW NT syringe.
Preparing GEL-FLOW NT:
NOTE: GEL-FLOW NT may be prepared to desired consistency (by adjusting the
volume of saline used for hydration) up to 3 hours prior to application using standard
sterile technique. Following the instructions below will yield an average of 7 mL of
uniform mixture within the syringe, with a measured minimum delivery volume of
6 mL.
Using sterile technique:
1. Draw up 5 mL of sterile, isotonic sodium chloride solution (sterile saline) or a
solution of thrombin into an empty 10 mL sterile syringe with luer lock
(diluent and syringe not included).
2. Connect the GEL-FLOW NT syringe to the sterile saline or thrombin solution
syringe with the pre-attached connecting luer.
3. Begin mixing by pushing the sterile saline/thrombin solution into the
GEL-FLOW NT syringe. Wait briefly (10-15 seconds) to allow the Gelfoam
Sterile Powder to become saturated with the sterile saline/thrombin solution.
4. Push the hydrated gelatin back into the sterile saline/thrombin solution
syringe. Continue exchanging the solution between syringes until all
components are thoroughly mixed (approximately 10 exchanges) and the
consistency is even. If at any point the mixture does not appear uniform,
perform additional exchanges between syringes to ensure contents are
adequately mixed and the resulting mixture looks homogenous.
5. Disconnect the mixing syringe containing the hydrated gelatin. Remove
connecting luer and attach an applicator tip, if desired. Two applicator tips
(one white malleable and one clear trimmable) with retainer clip are provided.
The clear trimmable applicator tip should be cut at a square angle to avoid
creating a sharp tip. GEL-FLOW NT may also be dispensed directly from the
syringe.
GEL-FLOW NT can be used saturated with sterile, isotonic sodium chloride solution
(sterile saline) or a solution of thrombin, as an adjunct to hemostasis. The resulting
mixture may be smeared, filled, or pressed against the bleeding surface to control
bleeding. When bleeding stops, the excess GEL-FLOW NT should be removed.
Use only the minimum amount of GEL-FLOW NT necessary to produce hemostasis.
The GEL-FLOW NT may be left in place at the bleeding site, when necessary. Since
GEL-FLOW NT causes little more cellular reaction than does the blood clot, the
wound may be closed over it. GEL-FLOW NT may be left in place when applied to
mucosal surfaces until it liquefies. For use with thrombin, consult the thrombin insert
for complete prescribing information and proper sample preparation.
CONTRAINDICATIONS
GEL-FLOW NT should not be used in closure of skin incisions because it may
interfere with healing of the skin edges. This is due to mechanical interposition of
gelatin and is not secondary to intrinsic interference with wound healing.
GEL-FLOW NT should not be placed in intravascular compartments, because of the
risk of embolization.
Do not use GEL-FLOW NT in patients with known allergies to porcine collagen.
WARNINGS
GEL-FLOW NT is not intended as a substitute for meticulous surgical technique and
the proper application of ligatures, or other conventional procedures for hemostasis.
GEL-FLOW NT is supplied as a sterile product and cannot be resterilized. Unused,
opened GEL-FLOW NT syringes or packs should be discarded.
To prevent contamination, employ aseptic procedure in opening the GEL-FLOW NT
package and removing the GEL-FLOW NT syringe. If the package is torn or
punctured, the contained Gelfoam Sterile Powder should not be used.
Only the minimum amount of GEL-FLOW NT necessary to achieve hemostasis
should be used. Once hemostasis is attained, excess GEL-FLOW NT should be
carefully removed.
The use of GEL-FLOW NT is not recommended in the presence of infection.
GEL-FLOW NT should be used with caution in contaminated areas of the body. If
signs of infection or abscess develop where GEL-FLOW NT has been positioned,
reoperation may be necessary in order to remove the infected material and allow
drainage.
Although the safety and efficacy of the combined use of GEL-FLOW NTwith other
agents such as topical thrombin has not been evaluated in controlled clinical trials, if
in the physician's judgment concurrent use of other agents is medically advisable, the
product literature for that agent should be consulted for complete prescribing
information.
While packing a cavity for hemostasis is sometimes surgically indicated,
GEL-FLOW NT should not be used in this manner unless excess product not needed
to maintain hemostasis is removed.
Whenever possible, GEL-FLOW NT should be removed after use in laminectomy
procedures and from foramina in bone, once hemostasis is achieved. This is because
GEL-FLOW NT may swell on absorbing fluids, and produce nerve damage by
pressure within confined bony spaces.
The packing of GEL-FLOW NT, particularly within bony cavities, should be avoided,
since swelling may interfere with normal function and/or possibly result in
compression necrosis of surrounding tissues.
PRECAUTIONS
The minimum amount of GEL-FLOW NTneeded for hemostasis should be applied
together with pressure until the bleeding stops. The excess should then be removed.
GEL-FLOW NT should not be used for controlling postpartum hemorrhage or
menorrhagia.
It has been demonstrated that fragments of another hemostatic agent, microfibrillar
collagen, pass through the 40μm transfusion filters of blood scavenging systems.
GEL-FLOW NT should not be used in conjunction with autologous blood salvage
circuits since the safety of this use has not been evaluated in controlled clinical trials.
Microfibrillar collagen has been reported to reduce the strength of methylmethacrylate
adhesives used to attach prosthetic devices to bone surfaces. As a precaution,
GEL-FLOW NT should not be used in conjunction with such adhesives.
GEL-FLOW NT is not recommended for the primary treatment of coagulation
disorders.
It is not recommended that GEL-FLOW NT be saturated with an antibiotic solution or
dusted with antibiotic powder.
Positioning of the patient resulting in negative peripheral venous pressure during a
procedure has been reported to be a contributing factor resulting in life-threatening
thromboembolic events.
ADVERSE REACTIONS
There have been reports of fever associated with the use of GELFOAM, without
demonstrable infection. GELFOAM may serve as a nidus for infection and abscess
formation1
, and has been reported to potentiate bacterial growth. Giant-cell granuloma
has been reported at the implantation site of absorbable gelatin product in the brain2
,
as has compression of the brain and spinal cord resulting from the accumulation of
sterile fluid.3
Foreign body reactions, "encapsulation" of fluid and hematoma have also been
reported.
When GELFOAM was used in laminectomy operations, multiple neurologic events
were reported, including but not limited to cauda equina syndrome, spinal stenosis,
meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction,
and impotence.
Excessive fibrosis and prolonged fixation of a tendon have been reported when
absorbable gelatin products were used in severed tendon repair.
Toxic shock syndrome has been reported in association with the use of GELFOAM in
nasal surgery.
Fever, failure of absorption, and hearing loss have been reported in association with
the use of GELFOAM during tympanoplasty.
ADVERSE REACTIONS REPORTED FROM UNAPPROVED USES
GELFOAM is not recommended for use other than as an adjunct for hemostasis.
While some adverse medical events following the unapproved use of GELFOAM
have been reported to Pharmacia & Upjohn Company (see ADVERSE
REACTIONS), other hazards associated with such use may not have been reported.
When GELFOAM has been used during intravascular catheterization for the purpose
of producing vessel occlusion, the following adverse events have been reported; fever,
duodenal and pancreatic infarct, embolization of lower extremity vessels, pulmonary
embolization, splenic abscess, necrosis of specific anatomic areas, asterixis, and
death.
The following adverse medical events have been associated with the use of
GELFOAM for repair of dural defects encountered during laminectomy and
craniotomy operations: fever, infection, leg paresthesias, neck and back pain, bladder
and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and
paresis.
ADVERSE EVENTS ASSOCIATED WITH BONE HEMOSTASIS
In a clinical study, 108 patients received GELFOAM Sterile Powder on the cut
surface of the sternum during cardiopulmonary bypass surgery, while 107 patients
received no treatment on the cut surface of the bone. Table 1 is a summary of medical
events reported by at least 1.0% of patients in a treatment group. The most frequently
reported events were atrial fibrillation, perioperative event, and wound infection.
Events occurring in less than 1.0% of the patients were as follows: anaphylaxis,
cardiogenic shock, delirium tremens, infection at the vascular catheter site,
unevaluable reaction, sepsis, angina pectoris, atrial arrhythmia, nodal arrhythmia,
arteriosclerosis, cardiac insufficiency, cardiac tamponade, cardiomyopathy, deep vein
thrombosis, mitral valve disorder, endocarditis, ventricular extrasystoles, heart arrest,
hypotension, mesenteric occlusion, superventricular tachycardia, thrombophlebitis,
thrombosis, gastrointestinal disorder, gastrointestinal bleeding, increased serum
creatinine, dehydration, anemia, thrombocytopenia, abnormal healing, hypovolemia,
hypoxia, metabolic acidosis, cerebral infarction, visual hallucinations, stupor,
aspiration pneumonia, chest congestion, pleural effusion, pulmonary infiltration,
retinal artery occlusion, anuria, UG disorder, abnormal kidney function and
menorrhagia.
Table 1: Summary of Medical Events for GELFOAM Sterile Powder when used
as a Bone Hemostatic Agent During Cardiopulmonary Bypass Surgery
GELFOAM Control Total
Medical Event N=108 N=107 N=215
n % n % n %
Atrial Fibrillation 14 (13) 12 (11) 26 (12)
Wound Infection 6 (6) 1 (0.9) 7 (3.3)
Perioperative Event 4 (4) 5 (4.7) 9 (4.2)
Congestive Heart
Failure
4 (4) 0 (0) 4 (1.9)
Ventricular
Tachycardia
2 (2) 3 (2.8) 5 (2.3)
Atrial Flutter 2 (2) 0 (0) 2 (0.9)
Peripheral Vascular
Disorder
2 (2) 0 (0) 2 (0.9)
Pneumothorax 2 (2) 3 (2.8) 5 (2.3)
Respiratory Failure 2 (2) 2 (1.9) 4 (1.9)
Respiratory Arrest 2 (2) 1 (0.9) 3 (1.4)
Fever 1 (1) 2 (1.9) 3 (1.4)
Heart Block 1 (1) 2 (1.9) 3 (1.4)
Prolonged Wound
Drainage
0 (0) 1 (0.9) 1 (0.5)
Cellulitis 0 (0) 2 (1.9) 2 (0.9)
Dyspnea 0 (0) 2 (1.9) 2 (0.9)
Pneumonia 0 (0) 2 (1.9) 2 (0.9)
In general, the following adverse events have been reported with the use of absorbable
porcine gelatin-based hemostatic agents:
� Gelatin-based hemostatic agents may serve as a nidus for infection and abscess
formation and have been reported to potentiate bacterial growth.
� Giant cell granulomas have been observed at implant sites when used in the brain.
� Compression of the brain and spinal cord resulting from the accumulation of sterile
fluid has been observed.
� Multiple neurologic events were reported when absorbable gelatin-based hemostatic
agents were used in laminectomy operations, including cauda equina syndrome, spinal
stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel
dysfunction, and impotence and paresis.
� The use of absorbable gelatin-based hemostatic agents have been associated with
paralysis, due to device migration into foramina in the bone around the spinal cord,
and blindness due to device migration in the orbit of the eye, during lobectomy,
laminectomy and repair of a frontal skull fracture and lacerated lobe.
� Foreign body reactions, "encapsulation" of fluid, and hematoma have been observed
at implant sites.
� Excessive fibrosis and prolonged fixation of a tendon have been reported when
absorbable gelatin-based sponges were used in severed tendon repair.
� Toxic shock syndrome was reported in association with the use of absorbable
gelatin-based hemostats in nasal surgery.
� Fever, failure of absorption, and hearing loss have been observed when absorbable
hemostatic agents were used during tympanoplasty.
CLINICAL STUDIES
GELFOAM Sterile Powder is a water-insoluble, hemostatic device prepared from
purified skin gelatin, and capable of absorbing up to 45 times its weight of whole
blood.4
The absorptive capacity of GELFOAM is a function of its physical size,
increasing as the amount of the gelatin powder increases.5
The mechanism of action of surface-mediated hemostatic devices is supportive and
mechanical.5
Surface acting devices, when applied directly to bleeding surfaces, arrest
bleeding by the formation of an artificial clot and by producing a mechanical matrix
that facilitates clotting.6
Jenkins et al 7
have theorized that the clotting effect of
GELFOAM may be due to release of thromboplastin from platelets, occurring when
platelets entering the sponge become damaged by contact with the walls of its myriad
of interstices. Thromboplastin interacts with prothrombin and calcium to produce
thrombin, and this sequence of events initiates the clotting reaction. The authors
suggest that the physiologic formation of thrombin in the sponge is sufficient to
produce formation of a clot, by its action on the fibrinogen in blood.7
The spongy
physical properties of the gelatin sponge hasten clot formation and provide structural
support for the forming clot.6,8
Several investigators have claimed that GELFOAM becomes liquefied within a week
or less and is completely absorbed in four to six weeks, without inducing excessive
scar formation.4,7,9,10,11 Barnes10 reviewed experiences with GELFOAM in
gynecologic surgery. No excessive scar tissue, attributable to the absorption of
GELFOAM, could be palpated at postoperative examination.
Bone Hemostasis Study:
The efficacy of GELFOAM Sterile Powder as a bone hemostatic agent during
cardiopulmonary bypass surgery was evaluated.
Study Design
Two randomized open-label clinical studies were conducted at separate investigative
sites. The objectives were as follows:
� To evaluate the effectiveness of GELFOAM Sterile Powder as a hemostatic agent in
the treatment of sternal bone bleeding during cardiopulmonary bypass surgery.
� To identify any deleterious effects of GELFOAM Sterile Powder on interference
with bone healing.
� To determine any systemic or local wound side effects from leaving GELFOAM
Sterile Powder in situ.
Patients between the ages of 18 to 74 years old undergoing cardiopulmonary bypass
surgery were randomly assigned to either a GELFOAM group or a Control group. The
GELFOAM group (composed of 108 patients) had a paste made up of sterile saline
solution and GELFOAM Sterile Powder applied to the cut sternal surface
immediately following sternotomy. The Control group (composed of 107 patients
received no treatment applied to the cut surface.
Blood loss was monitored both during surgery and postoperatively. Blood loss during
surgery was determined by measuring the weight of the powder before and after
application to the cut edge of the sternum. Postoperative blood loss was collected
from the mediastinal drainage tubes. The total blood loss (in milligrams) over
72 hours was determined for each patient.
Study Endpoints
Patients were evaluated upon admission (preoperative), during surgery
(intraoperative), after surgery (postoperative), upon hospital discharge (7 to 10 days
after surgery), and at the 3-month follow-up visit. An additional poststudy follow-up
was required if a patient reported an ongoing medical event at the 3-month follow-up
visit.
Study Results
In both studies, the amount of blood loss was significantly less in the GELFOAM
group than in the Control group. In Study 001, the mean blood loss in the GELFOAM
group was 13727.7 mg while the mean blood loss in the Control group was more than
double at 27712.0 mg. Similar results were found in Study 002, where the mean blood
loss in the GELFOAM group was 9514.8 mg while the mean blood loss in the Control
group was 22687.5 mg.
Table 2: Blood Loss in Sternotomy Patients
Site 001 Site 002
GELFOAM Control GELFOAM Control
Mean Blood Loss (mg) 13727.7 27712.0 9514.8 22687.5
Median Blood Loss (mg) 11561.0 24798.0 6950.0 16900.0
Minimum Blood Loss (mg) 2922.0 10748.0 800.0 900.0
Maximum Blood Loss (mg) 87448.0 61535.0 46000.0 89800.0
Patients in the GELFOAM and Control groups were similar with regard to sternal
bone healing. At hospital discharge, normal bone healing was reported for 105
patients (97%) in the GELFOAM group and 104 patients (97%) in the Control group.
At the 3-month follow-up, 103 patients (95%) in the GELFOAM group and 100
patients (93%) in the Control group were healed.
Few patients in either treatment group had sternotomy infection or other postoperative
infection complications related to sternotomy. At hospital discharge, two patients
treated with GELFOAM had mediastinitis. No Control patients had any infections at
hospital discharge. One patient treated with GELFOAM had a non-infection related
complication.
At the 3-month follow-up, one of the original patients treated with GELFOAM who
had mediastinitis still showed signs of infection. In addition, two additional patients
treated with GELFOAM developed mediastinitis at the 3-month follow-up.
One patient in the Control group experienced sternal osteomyelitis at the 3-month
follow-up but recovered with no residual effects. No patients from the GELFOAM
arm of the study had reported complications of sternal osteomyelitis.
There was a total of four Control patients who had non-infection related
complications.
One Control patient had serous/sanguineous wound drainage from the left leg and
sternum incisions at hospital discharge. This complication was non-infectious and the
patient recovered with no residual side effects.
Three Control patients all experienced chronic pain syndrome, a symptom which can
occur following thoracic/cardiac surgery. Evaluation sternal bone healing at the
3-month follow-up for these patients showed no evidence of non-union of the
sternum. In all three cases, bone healing at the 3-month follow-up was reported as
being normal. A summary of sternotomy infection information is located in Table 3.
Table 3: Summary of Postoperative Infection Complications
Hospital Discharge 3-Month Follow-up
GELFOAM Control GELFOAM Control
N % N % N % N %
Any Infection
yes 1 (1) 0 (0) 5 (5) 0 (0)
no 104 (99) 106 (100) 95 (95) 105 (100)
Superficial Wound
yes 0 (0) 0 (0) 2 (2) 0 (0)
no 105 (100) 106 (100) 98 (98) 105 (100)
Sternal Osteomyelitis
yes 0 (0) 0 (0) 1 (1) 1 (1)
no 105 (100) 106 (100) 99 (99) 105 (99)
Mediastinitis
yes 1 (1) 0 (0) 2 (2) 0 (0)
no 104 (99) 106 (100) 98 (98) 105 (100)
Complication Related to Sternotomy
yes 0 (0) 0 (0) 1 (1) 3 (3)
no 105 (100) 106 (100) 99 (99) 102 (97)
Study Conclusions
These studies demonstrate that a paste made from GELFOAM Sterile Powder is safe
and effective in treating intraoperative bleeding when applied to the cut surface of
cancellous bone and has shown superior hemostasis versus no treatment at all to the
cut bone surface. The benefit to patients is that a reduction in bleeding will make
surgery easier to perform by reducing the time the surgeon needs to revisit cut bone
surfaces to clean up the bleeding. This study also demonstrated that GELFOAM
Sterile Powder could be left in situ without increased risk of bone infection or
non-union of the sternum.
NON-CLINICAL STUDIES
Thrombin Concentration Study16
In a randomized, controlled, blinded pre-clinical study conducted on a liver lesion
model in swine, an inverse dose related response was observed between the thrombin*
concentration within the GEL-FLOW NT syringe and the visual bleeding scores.
Bleeding was assigned scores according to a visual scale (Adams et al. 2009
15
), with
scores of 0 (no bleeding), 0.5 (ooze), 1 (very slight), 2 (slight), 3 (moderate), and 4
(severe). Scores of 1 and less were considered clinically acceptable. The 770 IU/mL
thrombin concentration provided statistically lower bleeding scores than either
375 IU/mL or 250 IU/mL thrombin concentrations** (Table 4). The results of this
study showed that higher concentrations of thrombin within the GEL-FLOW NT
syringe resulted in improved hemostasis as measured by lower bleeding scores.
*
Thrombin-JMI�
(Thrombin, Topical (Bovine) USP) was used for all thrombin
concentrations tested in this study.
**Per the Thrombin-JMI�
prescribing information,
for routine use THROMBIN-JMI is reconstituted with sterile isotonic saline at a
recommended concentration of 1,000 to 2,000 International Units per mL.
Table 4: Comparison of Effect on Hemostasis of Varying Thrombin
Concentrations in GEL-FLOW NT as Measured by Bleeding Scores in Swine
Liver Lesion Model
Comparison of Effect on Bleeding Scores of Varying
Thrombin Concentrations in GEL-FLOW NT in
Animal Model using Repeated Measures Logistic
Regression
Parameter 250
IU/mL
Mean
(Standard
Error)
375 IU/mL
Mean
(Standard
Error)
770 IU/mL
Mean
(Standard
Error)
3 Minute
Bleeding
Score
1.8 (0.2) 1.6 (0.2) 0.7 (0.2)**
6 Minute
Bleeding
Score
1.7 (0.2) 1.5 (0.2) 0.6 (0.2)**
9 Minute
Bleeding
Score
1.5 (0.2) 1.2 (0.2) 0.5 (0.2)**
12 Minute
Bleeding
Score
1.4 (0.2) 1.0 (0.2)*
0.4 (0.2)**
*
Significantly different from 250 IU/mL at the 0.05 significance level. Tukey adjusted p-value for
multiple comparisons.
**Significantly different from both 250 and 375 IU/mL at <0.001 significance level. Tukey
adjusted p-values for multiple comparisons.
DOSAGE AND ADMINISTRATION
Sterile technique should always be used. The minimum amount of hydrated
GEL-FLOW NT should be applied to the bleeding site (see DIRECTIONS FOR USE)
with pressure until hemostasis is observed. Unused GEL-FLOW NT should always be
discarded.
HOW SUPPLIED
GEL-FLOW NT is provided in an inner sterile pouch which contains 550 mg
GELFOAM Sterile Powder in a 10 mL syringe to yield a minimum delivery volume
of 6 mL GEL-FLOW NT if prepared per instructions, supplied with a connector luer
and two applicator tips (white malleable and clear trimmable) with retainer clip, 2
syringe labels: GTIN 00300091040016.
GEL-FLOW� NT is supplied in the GEL-FLOW� Kit:
GEL-FLOW� Kit (GEL-FLOW� NT Absorbable Gelatin Powder and Thrombin,
Topical (Bovine) U.S.P., THROMBIN-JMI�
, 5,000 IU Syringe Spray Kit).
GTIN 00300092250018.
STORAGE AND HANDLING
GEL-FLOW NT should be stored at 25�C (77�F); excursions permitted to 15-30�C
(59-86�F) [see USP Controlled Room Temperature]. Once the Gelfoam Sterile
Powder in the GEL-FLOW NT is hydrated within the syringe, contents are subject to
contamination. GEL-FLOW NT may be prepared up to 3 hours prior to application
using standard sterile technique. It is recommended that the product be used as soon
as the GEL-FLOW NT is properly hydrated and unused contents be discarded. This
product is prepackaged sterile and intended only for single use. It is not intended
for resterilization or reuse. Reuse can result in transmission of bloodborne
pathogens (including HIV and hepatitis), potentially endangering patients and
health care providers. Adherence to the principles of aseptic technique when using
this product is essential.
Caution: Federal law restricts this device to sale by or on the order of a physician.
ANIMAL PHARMACOLOGY
Surface-acting hemostatic devices, when applied directly to bleeding surfaces, arrest
bleeding by providing a mechanical matrix that facilitates clotting.6,8,13,14 Due to their
bulk, surface-acting hemostatic agents slow the flow of blood, protect the forming
clot, and offer a framework for deposition of the cellular elements of blood.6,7,8,13
MacDonald and Mathews12 studied GELFOAM implants in canine kidneys and
reported that it assisted in healing, with no marked inflammatory or foreign-body
reactions.
Jenkins and Janda13 studied the use of GELFOAM in canine liver resections and
noted that the gelatin sponge appeared to offer a protective cover and provide
structural support for the reparative process.
Correll et al14
studied the histology of GELFOAM Sterile Sponge when implanted in
rat muscle and reported no significant tissue reaction.
REFERENCES
1. Lindstrom PA: Complications from the use of absorbable hemostatic sponges. AMA
Arch Surg 1956;73:133-141.
2. Knowlson GTG: Gelfoam granuloma in the brain. J Neuro Neurosurg Psychiatry
1974;37:971-973.
3. Herndon JH, Grillo HC, Riseborough EJ, et al: Compression of the brain and spinal
cord following use of GELFOAM. Arch Surg 1972;104:107.
4. Council on Pharmacy and Chemistry: Absorbable Gelatin sponge � new and
nonofficial remedies. JAMA 1947;135:921.
5. Goodman LS, Gilman A: Surface-acting drugs, in The Pharmacologic Basis of
Therapeutics, ed 6. New York, MacMillan Publishing Co. 1980, p 955.
6. Guralnick W, Berg L: GELFOAM in oral surgery. Oral Surg 1948;1:629-632.
7. Jenkins HP, Senz EH, Owen H, et al: Present status of gelatin sponge for control of
hemorrhage. JAMA 1946;132:614-619.
8. Jenkins HP, Janda R, Clarke J: Clinical and experimental observations on the use of
gelatin sponge or foam. Surg 1946;20:124-132.
9. Treves N: Prophylaxis of post mammectomy lymphedema by the use of
GELFOAM laminated rolls. Cancer 1952;5:73-83.
10. Barnes AC: The use of gelatin foam sponges in obstetrics and gynecology. Am J
Obstet Gynecol 1963;86:105-107.
11. Rarig HR: Successful use of gelatin foam sponge in surgical restoration of
fertility. Am J Obstet Gynecol 1963;86:136.
12. MacDonald SA, Mathews WH: Fibrin foam and GELFOAM in experimental
kidney wounds. Annual American Urological Association, July 1946.
13. Jenkins HP, Janda R: Studies on the use of gelatin sponge or foam as a hemostatic
agent in experimental liver resections and injuries to large veins. Ann Surg
1946;124:952-961.
14. Correll JT, Prentice HR, Wise EC: Biologic investigations of a new absorbable
sponge. Surg Gynecol Obstet 1945;181:585-589.
15. Adams G, Manson R, Hasselblad V, Shaw L, Lawson J: Acute in-vivo evaluation
of bleeding with Gelfoam� plus saline and Gelfoam plus human thrombin using an
liver square lesion model in swine. J Throm Thrombolysis 2009; 28: 1-5.
16. Morse DC, Silva E, Bartrom J, Young K, Bass EJ, Potter D, Bieber T: Improved
bleeding scores using Gelfoam� Powder with incremental concentrations of bovine
thrombin in a swine liver lesion model. J Throm Thrombolysis 2016; 42(3): 352-359.
This product's label may have been updated. For current full instructions for use,
please visit www.pfizer.com.
DO NOT RE-USE
Method of sterilization using gamma irradiation
Attention, see instructions for use
CONSULT Instructions for Use
DO NOT RESTERILIZE
DO NOT USE IF PACKAGE IS DAMAGED
1-800-438-1985
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LAB-0762-4.0
Revised May 2018
