Question 1

Why does SealFoam® sometimes stick to gauze, gloves, and forceps?

Accepted Answer

SealFoam® is derived from plant starch and is naturally adhesive when applied to moist surfaces such as human or organ tissue.  Care must be taken to avoid using wet gloves or instruments when applying SealFoam®.
This adhesive property is a significant benefit when applying SealFoam® as it will maintain its’ position and not slip or slide as often experienced with oxidized cellulose or gelatin sponges. Moist gauze may be used to apply pressure when required.

Question 2

Can be SealFoam® used in spinal surgery?

Accepted Answer

Yes, SealFoam® can be used effectively in spine surgery.  See paper from Dr. Biren Desai: SealFoam® Polysaccharide Hemostat – Hemostat in arresting bleeding during spine surgery.(https://845a9235-6ed6-49e8-bafd-bcde8713f99e.filesusr.com/ugd/1c867f_4398b10750d944e4a9840e198b85aa42.pdf)  Cologne, Germany July 1, 2011.

Question 3

Is SealFoam® a gelatin sponge?

Accepted Answer

No, SealFoam® is not a gelatin sponge.  Gelatin sponges are used to attempt to control bleeding and are typically very absorbent. They are developed by partial hydrolysis of collagen derived from skin, white connective tissue, and bones of animals (porcine, bovine and/or equine) and it takes four to six weeks to be completely absorbed in the body.  SealFoam® contains no human or animal components and is absorbed in the body within a few days.

Question 4

Is SealFoam® like Spongostan™?

Accepted Answer

Spongostan™ is a porcine gelatin sponge and represents another version of a gelatin sponge.  (See: Is SealFoam® a gelatin sponge?).  Spongostan™ should not be used in patients with known allergies to porcine collagen.  Patients with religious beliefs surrounding pork or bovine should be consulted prior to usage. Spongostan™ should be removed from the body to avoid the possibility of dislodgement of the device or compression of other nearby anatomic structures.  SealFoam® can be used on patients with porcine allergies as SealFoam® contains no animal components.  SealFoam® can be left in the body and will be absorbed within a few days.

Question 5

What is SealFoam® made from?

Accepted Answer

SealFoam® is derived from purified plant starch, which goes through a proprietary engi­neering process that modifies the plant starch into an ultra-hydrophilic, adhe­sive forming hemostatic material. The material is biocompatible, non-pyrogenic, latex free, absorbable and contains no animal or human components, thereby eliminating risks associated with the transfer of animal and human pathogens.

Question 6

Can either side of SealFoam® be applied to bleeding site?

Accepted Answer

Yes.  Since SealFoam® is composed of one single material, there is no difference between the top and the bottom.  Either side can be applied on the bleeding site with equal effectiveness.  It is import to make sure that excess blood is removed prior to applying SealFoam®.

Question 7

What is the difference between SealFoam® and PerClot®?

Accepted Answer

Both SealFoam® and PerClot® are made from Absorbable Modified Polymer (AMP®) particles. PerClot® is provided in a powder format.  SealFoam® is in solid pad format.  Since the solid format can be cut to various sizes and dimensions it allows for easy application to many types of wound sites. Additionally, it easily accommodates the application of direct pressure on SealFoam® to assist the stoppage of bleeding.  Please note that while RESPONDER® is also made from AMP® particles, it is designed and labeled for topical use, not for surgical use.

Question 8

Is irrigation of SealFoam® necessary after hemostasis is achieved?

Accepted Answer

No, irrigation is optional in most cases.  SealFoam® is absorbed in the body within a few days.   Additionally, SealFoam® has been reported to reduce post-operative fluid drainage.  For more information see Clinical Papers, Dr. Bussone.(https://845a9235-6ed6-49e8-bafd-bcde8713f99e.filesusr.com/ugd/1c867f_e2c9e816ef824615970bf9e4fe410de1.pdf)

Question 9

When SealFoam® is placed how much pressure should be applied?

Accepted Answer

In very minor bleed scenarios it is often not required to apply pressure.  Remember, SealFoam® is naturally adhesive so it is not required to “hold it” in place after application. In moderate bleeding scenarios, gentle pressure should be applied for a minimum of 90 seconds.  Ensure that SealFoam® covers the entire bleeding area and that excess blood is removed immediately prior to applying SealFoam®.  Also consider using 2 or 3 layers of SealFoam® and applying firm pressure in more challenging bleeding scenarios.  Avoid moving SealFoam® once it has been placed

Question 10

How long does SealFoam® stay in the body?

Accepted Answer

SealFoam® will be absorbed in the body within several days.

Question 11

Why does SealFoam® turn into a gel?

Accepted Answer

SealFoam® is ultra-hydrophilic, and has a molecular structure that rapidly absorbs water from blood.  This generates a high concentration of platelets accelerating the coagulation cascade.  As SealFoam® absorbs significant moisture it forms a gelled adhesive matrix that provides a mechanical barrier to further arrest bleeding.

Question 12

What bleeding scenarios are recommended for SealFoam®?

Accepted Answer

SealFoam® is indicated for use in surgical procedures or injuries as an adjunct hemostat when control of bleeding from capillary, venous, or arteriolar vessels by pressure, ligature, and other conventional means is either ineffective or impractical. SealFoam® is ideal in oozing or minor bleeding scenarios.  SealFoam® can also be effective in moderate bleeding scenarios but consider using 2-3 layers of SealFoam® and applying pressure for 90 seconds to 3 minutes. Also, SealFoam® has been reported to be effective in reducing post-operative drainage.

See Clinical Papers, Dr. Bussone.(https://845a9235-6ed6-49e8-bafd-bcde8713f99e.filesusr.com/ugd/1c867f_e2c9e816ef824615970bf9e4fe410de1.pdf) SealFoam® works in most surgical scenarios however is not intended as a substitute for good surgical practice, and in particular, the proper use of conventional procedures (such as ligature) for hemostasis.

Question 13

How much fluid can absorb SealFoam®?

Accepted Answer

SealFoam® is naturally very hydrophilic.  On average, one piece of SealFoam® (PD644) weighs approximately 0.9 grams and will absorb up to 26ml of fluid.