Directions for use
The Absorbable Collagen Wound Dressings for Dental Surgery (Heli-
Tape, HeliCote, HeliPlug) are soft, white, pliable, nonfriable sponges.
Because of the coherent sponge structure, application of the dressings
to the wound is easily controlled. The dressings retain their structural integrity
even when wet. Unwanted dispersal from the site is not encountered.
The Absorbable Collagen Wound Dressings for Dental Surgery are
very porous. Greater than 90% of the dressing consists of open pores,
which can fill with fluid. The dressings are highly absorbent, holding many
times their own weight of saline solution. The basic material from which the
Absorbable Collagen Wound Dressings for Dental Surgery are fabricated
is collagen obtained from bovine deep flexor (Achilles) tendon. The tendon
is one of the purest sources of collagen that can be readily obtained and
processed in commercial quantities. Because of the high initial purity and
further processing achieved during manufacture, the sponges are safe and
effective wound dressings that exhibit very consistent behavior. The Absorbable
Collagen Wound Dressings for Dental Surgery are nontoxic and
nonpyrogenic, and each dressing is packaged individually. The sterility of
the dressing is guaranteed unless the package is opened or damaged.
The Absorbable Collagen Wound Dressings for Dental Surgery are indicated
for application to moist or bleeding clean oral wounds created
during dental surgery, to control bleeding and protect the surface of the
wound from further injury. Topical administration of the Absorbable Collagen
Wound Dressings directly over the wound effectively controls bleeding
usually within two to five minutes. The Absorbable Collagen Wound
Dressings for Dental Surgery, are intended for use on moist or bleeding
wounds where a stabilized blood clot can help protect the surface of the
wound from further injury. The Absorbable Collagen Wound Dressings are
indicated during prolonged dental procedures where maintaining a clear
surgical field and ease of use are beneficial factors in treating oral wounds.
In situations where frequent aspiration is required to remove accumulated
blood and exudate, the Absorbable Collagen Wound Dressings can be
used to dress bleeding or oozing wounds and thereby improve patient
comfort. Since the Absorbable Collagen Wound Dressings can be easily
removed without damaging the wound bed, they can be used as temporary
dressings prior to surgical closure.
INFORMATION FOR USE
The Absorbable Collagen Wound Dressings for Dental Surgery have
been shown to have good adherence to moist wounds. The highly porous
sponge structure absorbs blood and wound exudate. An inherent property
of native collagen is the ability to promote hemostasis. In contact with
blood, collagen is known to cause aggregation of platelets, which bind in
large numbers to the collagen fibrils. The aggregated platelets degranulate,
releasing coagulation factors that enable, together with plasma factors,
the formation of Fibrin. The sponge structure of the Absorbable Collagen
Wound Dressings provides a three-dimensional matrix for additional
strengthening of the blood clot. In vivo studies using guinea pigs showed
that the incidence of infection (abscess) of incision sites inoculated with
Staphylococcus aureus was not enhanced by the presence of the Absorbable
Collagen Wound Dressings when compared to another collagen hemostatic
agent. However, extent of wound infection tended to be greater
than control with the Absorbable Collagen Wound Dressings and another
collagen hemostatic agent tested. This tendency is observed with many
foreign substances. The Absorbable Collagen Wound Dressings for Dental
Surgery have been tested for potential allergenic sensitivity and cytotoxicity.
The sponges contain no toxic leachable, do not produce tissue irritation,
and show no contact sensitization upon repeat challenge. Passive hemagglutination,
which is a sensitive test for potential antigenicity, was used
with the Absorbable Collagen Wound Dressings as the antigen. There was
no agglutination observed. The Absorbable Collagen Wound Dressings for
Dental Surgery are tested and certified as nonpyrogenic.
The Absorbable Collagen Wound Dressings for Dental Surgery should not
be used on infected or contaminated wounds. Although the Absorbable
Collagen Wound Dressings will promote hemostasis, they are not intended
for use in treating systemic coagulation disorders. Store the Absorbable
Collagen Wound Dressings in scaled packages at room temperature.
Avoid excessive heat or humidity. Discard all open but unused dressings.
Do not attempt to re-sterilize. The material has not been tested on pregnant
women. The risk to health has not been established. The long-term
effects of leaving the Absorbable Collagen Wound Dressings in situ are
A sufficiently large Absorbable Collagen Wound Dressing should be selected
so as to completely cover the oral wound. The wound should be
rinsed clean and excess fluid removed. The dressing should be applied
over the wound and held in place with moderate pressure. The period of
time necessary to apply pressure will vary with the degree of bleeding. In
general, two to five minutes should be sufficient to achieve hemostasis.
At the end of the procedure, the Absorbable Collagen Wound Dressing
can be removed, replaced or left in situ. If desired, the Absorbable Collagen
Wound Dressing can be covered with a periodontal packing to help
hold the sponge in place. The Absorbable Collagen Wound Dressing may
be left in situ, when necessary. However, the dentist should remove any
excess dressing prior to wound closure.
Adverse reactions reported with another microfibrillar collagen hemostatic
agent that were possibly related to its use were adhesion formation, allergic
reaction, foreign body reaction and subgaleal seroma (report of a
single case). Since the wound dressings are collagen-based products,
adverse reactions experienced with another microfibrillar collagen may be
related. The Absorbable Collagen Wound Dressings for Dental Surgery
differ substantially in source, method of processing, and purity from other
microfibrillar and microfibrillar forms of collagen commercially distributed
for hemostatic and wound care applications.