Adverse reactions, Instructions – Integra LifeSciences Collagen Wound Dressing, HeliTape, HeliCote, HeliPlug User Manual

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Adverse Reactions

• 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 macrofibrillar forms of collagen

commercially distributed for hemostatic and wound care

applications.

Instructions

1. 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.
2. 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.

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