Frequently Asked Questions about BioSeal ADVANCED
and BioSeal CVC Topical Powders
For Medical Use
What is BioSeal Powder and how does it work?
BioSeal Powder is a topical powder that stops bleeding and forms a seal/scab over a wound. The powder is made of a
hydrophilic polymer and a potassium ferrate. The mechanism of action is a simultaneous two step action:
1. The polymer rapidly dehydrates the blood, stacking up the solid components. 2. The ferrate component agglomerates
the solid components creating an occlusive barrier. The powder is not biologically derived and not metabolized by the
body.
On what type of wounds can I apply BioSeal Powder?
BioSeal Powder is intended for use as a topical dressing for bleeding control associated with
wounds such as:
• External wounds that have blood, such as cuts, skin tears and avulsions
• Anterior epistaxis
• Cancerous lesions, diabetic ulcers and fungating tumors
BioSeal Powder is also indicated for control of minor external bleeding and exudate from
sutures or surgical procedures such as:
• Vascular access procedures (forms a seal providing extra-luminal protection over the insertion site and around
the line)
• Dermatological procedures, including punch biopsies, shaves, excisions and even Mohs Micrographic Surgery
Does BioSeal Powder work by cauterization or vasoconstriction?
No. BioSeal is a topical powder wound dressing. Unlike vasoconstrictors that only temporarily stop minor bleeding, or
cautery that has limited effectiveness and can damage tissue, BioSeal Powder works by forming a protective seal that
stops the flow of blood and prevents microbes from entering the wound.
Can BioSeal Powder cause allergic reactions?
The product is hypoallergenic. No allergic reactions have been reported.
Does BioSeal interact with any other medications?
BioSeal has passed all FDA-required safety and biocompatibility tests and there are no known interactions with other
medication.
Will BioSeal Powder work for people who bleed easily?
Yes. BioSeal Powder does not depend on the blood’s natural clotting mechanisms to be effective, so it will work for
people with blood disorders and those on anticoagulants/antiplatelet drugs, aspirin therapy, or other blood thinners. We
recommend patients consult their doctor as to whether these medications can be continued prior to a planned
procedure.
How much BioSeal Powder should I apply?
Apply as much BioSeal Powder as it takes to completely cover the wound and any blood around it. Ensure there is a
layer of dry powder on top of the wound before applying pressure.
Is there any discomfort with the use of BioSeal Powder?
For wounds with ample blood present there should be no discomfort felt at all. However, for wounds like abrasions,
where there is little blood present, a temporary warming sensation might be felt depending on the location and severity
of the wound.
Should BioSeal Powder be washed off after the blood flow has stopped?
No, it is important to keep the protective scab clean and dry until it has hardened (usually in one to two hours). Once the
seal/scab has hardened, the treated area can get wet or submerged in water (i.e., showering or swimming.)
Does the protective scab need to be removed?
No, the protective scab will fall off naturally.
After applying BioSeal Powder, do I need to cover a wound to protect it?
You can cover the wound if desired, however the scab will allow nothing into the wound, including germs, irritation and
dirt.
Can BioSeal Powder be applied along with other creams or ointments?
No, it is recommended to apply BioSeal Powder without the use of creams or ointments.
Will the BioSeal Powder stain or scar the skin?
Unlike other products on the market, BioSeal Powder does not stain or scar the skin.
Does BioSeal have a shelf life?
BioSeal has a shelf life of 2 1/2 years from the date of packaging. The expiration date is listed on each unit/package.
Do you have clinical or laboratory studies to prove that BioSeal Powder is safe and it works?
Yes. Biolife has conducted many studies on the Powder. You can view these studies here.
Can BioSeal get into the bloodstream?
No, BioSeal does not enter the bloodstream or migrate into a vessel.
Is there a risk of infection with the use of BioSeal?
No infections have been reported with the use of BioSeal. BioSeal Powder has passed all FDA-required safety and
toxicity testing. Recent in-vitro studies show that BioSeal Powder forms a seal that provides a microbial barrier over the
wound site such that nothing goes in and nothing comes out. On the distal side of the seal, pH is low, creating a hostile
environment against colonizing microbes. This testing also showed that PRO QR Powder killed common microbes for 7
days with a daily rechallenge.
How long should you hold manual pressure for when using BioSeal Powder to achieve
hemostasis?
Holding times are dependent on the type of procedure. We recommend that when you first use BioSeal Powder, you
follow your standard protocol for manual compression. As you become more accustomed to applying BioSeal Powder,
you may be able to decrease your holding times. On average, we recommend hold times of at least 30 seconds for
minor cuts and anterior epistaxis. For holding times for vascular access procedures, please see the chart below.
What are the post care instructions?
The seal should be left on until it falls off naturally. If the seal needs to be removed, soak the seal with sterile saline and
remove with gloved fingers or a tongue depressor.
Will the BioSeal Powder stain or scar the skin?
Unlike other products on the market, BioSeal Powder does not stain, scar or burn the skin.
Is it being used instead of wound closure, i.e. steri-strips, or just instead of band-aids?
BioSeal can be used on top of steri-strips for continued oozing after steri-strips have been used to approximate the
wound edges. On smaller wounds that do not look like they would require sutures, BioSeal is safe to use by itself.
Vascular Access
For vascular access procedures, how long should you hold manual pressure for when using
BioSeal Powder to achieve hemostasis?
Holding times are dependent on the type of procedure. We recommend that when you first use BioSeal Powder, you
follow your standard protocol for manual compression. As you become more accustomed to applying BioSeal Powder,
you may be able to decrease your holding times.
Common holding times for various procedures are shown in the table below. Note that
patients with compromised blood may require longer holding times.
Is there a risk of complications using BioSeal on a vascular access site?
Data from a clinical study published in the Journal of Vascular and Interventional Radiology (link) shows no increased
complications as compared to a leading hemostatic pad. In this study, there were no infections or adverse events and
there was no difference in hematoma rate (3% hematoma). As with any other method used to achieve hemostasis, the
patient should be monitored post sheath/catheter removal for bleeding/hematoma. The standard department post
procedure protocols used should be followed after the use of BioSeal. The patient should also know the signs and
symptoms of complications to look for when they leave the hospital. This is included in the product’s Patient Discharge
Instructions.
Does BioSeal have any effect on catheters?
No. BioSeal will not have any negative effects on polyurethane lines. The ingredients of the powder will not break down
plastic.
Can I use BioSeal Powder with Biopatch®?
BioSeal Powder and the Biopatch® should not be used at the same time. BioSeal Powder creates a seal that stops
bleeding and oozing, provides a microbial barrier, and can extend the initial dressing change to 7 days. Many hospitals
use BioSeal Powder up until the first dressing change (7 days) to and then use Biopatch® following this dressing
change.
Can BioSeal replace sutures for a port placement?
No, BioSeal is not for suture replacement. BioSeal stops bleeding from vascular access sites and external wounds.
BioSeal can be used on a port placement or removal site if it continues to bleed after sutures are placed. BioSeal
Powder can be placed directly on top of the sutures.
Can BioSeal be placed in a tunneled access tract to stop bleeding?
This would be considered off label use. BioSeal is not approved for internal use. BioSeal has been effective at stopping
bleeding when applied around the tunneled access site.
Nosebleed
Can I use PRO QR for Nosebleeds for a posterior nosebleed?
PRO QR Powder for Nosebleeds (with applicator) is indicated for anterior nosebleeds, which represent the 90% of
nosebleeds that take place in the lower, two-thirds of the nose. Nosebleeds that occur in the upper posterior require
other treatment approaches as directed by a medical professional. PRO QR Powder is currently not indicated for
posterior nosebleeds.
What is the applicator included with PRO QR for Nosebleeds made of?
The applicator is made of a special microfiber, specifically chenille. It loads and releases eight times more powder than
a standard cotton swab.
and BioSeal CVC Topical Powders
For Medical Use
What is BioSeal Powder and how does it work?
BioSeal Powder is a topical powder that stops bleeding and forms a seal/scab over a wound. The powder is made of a
hydrophilic polymer and a potassium ferrate. The mechanism of action is a simultaneous two step action:
1. The polymer rapidly dehydrates the blood, stacking up the solid components. 2. The ferrate component agglomerates
the solid components creating an occlusive barrier. The powder is not biologically derived and not metabolized by the
body.
On what type of wounds can I apply BioSeal Powder?
BioSeal Powder is intended for use as a topical dressing for bleeding control associated with
wounds such as:
• External wounds that have blood, such as cuts, skin tears and avulsions
• Anterior epistaxis
• Cancerous lesions, diabetic ulcers and fungating tumors
BioSeal Powder is also indicated for control of minor external bleeding and exudate from
sutures or surgical procedures such as:
• Vascular access procedures (forms a seal providing extra-luminal protection over the insertion site and around
the line)
• Dermatological procedures, including punch biopsies, shaves, excisions and even Mohs Micrographic Surgery
Does BioSeal Powder work by cauterization or vasoconstriction?
No. BioSeal is a topical powder wound dressing. Unlike vasoconstrictors that only temporarily stop minor bleeding, or
cautery that has limited effectiveness and can damage tissue, BioSeal Powder works by forming a protective seal that
stops the flow of blood and prevents microbes from entering the wound.
Can BioSeal Powder cause allergic reactions?
The product is hypoallergenic. No allergic reactions have been reported.
Does BioSeal interact with any other medications?
BioSeal has passed all FDA-required safety and biocompatibility tests and there are no known interactions with other
medication.
Will BioSeal Powder work for people who bleed easily?
Yes. BioSeal Powder does not depend on the blood’s natural clotting mechanisms to be effective, so it will work for
people with blood disorders and those on anticoagulants/antiplatelet drugs, aspirin therapy, or other blood thinners. We
recommend patients consult their doctor as to whether these medications can be continued prior to a planned
procedure.
How much BioSeal Powder should I apply?
Apply as much BioSeal Powder as it takes to completely cover the wound and any blood around it. Ensure there is a
layer of dry powder on top of the wound before applying pressure.
Is there any discomfort with the use of BioSeal Powder?
For wounds with ample blood present there should be no discomfort felt at all. However, for wounds like abrasions,
where there is little blood present, a temporary warming sensation might be felt depending on the location and severity
of the wound.
Should BioSeal Powder be washed off after the blood flow has stopped?
No, it is important to keep the protective scab clean and dry until it has hardened (usually in one to two hours). Once the
seal/scab has hardened, the treated area can get wet or submerged in water (i.e., showering or swimming.)
Does the protective scab need to be removed?
No, the protective scab will fall off naturally.
After applying BioSeal Powder, do I need to cover a wound to protect it?
You can cover the wound if desired, however the scab will allow nothing into the wound, including germs, irritation and
dirt.
Can BioSeal Powder be applied along with other creams or ointments?
No, it is recommended to apply BioSeal Powder without the use of creams or ointments.
Will the BioSeal Powder stain or scar the skin?
Unlike other products on the market, BioSeal Powder does not stain or scar the skin.
Does BioSeal have a shelf life?
BioSeal has a shelf life of 2 1/2 years from the date of packaging. The expiration date is listed on each unit/package.
Do you have clinical or laboratory studies to prove that BioSeal Powder is safe and it works?
Yes. Biolife has conducted many studies on the Powder. You can view these studies here.
Can BioSeal get into the bloodstream?
No, BioSeal does not enter the bloodstream or migrate into a vessel.
Is there a risk of infection with the use of BioSeal?
No infections have been reported with the use of BioSeal. BioSeal Powder has passed all FDA-required safety and
toxicity testing. Recent in-vitro studies show that BioSeal Powder forms a seal that provides a microbial barrier over the
wound site such that nothing goes in and nothing comes out. On the distal side of the seal, pH is low, creating a hostile
environment against colonizing microbes. This testing also showed that PRO QR Powder killed common microbes for 7
days with a daily rechallenge.
How long should you hold manual pressure for when using BioSeal Powder to achieve
hemostasis?
Holding times are dependent on the type of procedure. We recommend that when you first use BioSeal Powder, you
follow your standard protocol for manual compression. As you become more accustomed to applying BioSeal Powder,
you may be able to decrease your holding times. On average, we recommend hold times of at least 30 seconds for
minor cuts and anterior epistaxis. For holding times for vascular access procedures, please see the chart below.
What are the post care instructions?
The seal should be left on until it falls off naturally. If the seal needs to be removed, soak the seal with sterile saline and
remove with gloved fingers or a tongue depressor.
Will the BioSeal Powder stain or scar the skin?
Unlike other products on the market, BioSeal Powder does not stain, scar or burn the skin.
Is it being used instead of wound closure, i.e. steri-strips, or just instead of band-aids?
BioSeal can be used on top of steri-strips for continued oozing after steri-strips have been used to approximate the
wound edges. On smaller wounds that do not look like they would require sutures, BioSeal is safe to use by itself.
Vascular Access
For vascular access procedures, how long should you hold manual pressure for when using
BioSeal Powder to achieve hemostasis?
Holding times are dependent on the type of procedure. We recommend that when you first use BioSeal Powder, you
follow your standard protocol for manual compression. As you become more accustomed to applying BioSeal Powder,
you may be able to decrease your holding times.
Common holding times for various procedures are shown in the table below. Note that
patients with compromised blood may require longer holding times.
Is there a risk of complications using BioSeal on a vascular access site?
Data from a clinical study published in the Journal of Vascular and Interventional Radiology (link) shows no increased
complications as compared to a leading hemostatic pad. In this study, there were no infections or adverse events and
there was no difference in hematoma rate (3% hematoma). As with any other method used to achieve hemostasis, the
patient should be monitored post sheath/catheter removal for bleeding/hematoma. The standard department post
procedure protocols used should be followed after the use of BioSeal. The patient should also know the signs and
symptoms of complications to look for when they leave the hospital. This is included in the product’s Patient Discharge
Instructions.
Does BioSeal have any effect on catheters?
No. BioSeal will not have any negative effects on polyurethane lines. The ingredients of the powder will not break down
plastic.
Can I use BioSeal Powder with Biopatch®?
BioSeal Powder and the Biopatch® should not be used at the same time. BioSeal Powder creates a seal that stops
bleeding and oozing, provides a microbial barrier, and can extend the initial dressing change to 7 days. Many hospitals
use BioSeal Powder up until the first dressing change (7 days) to and then use Biopatch® following this dressing
change.
Can BioSeal replace sutures for a port placement?
No, BioSeal is not for suture replacement. BioSeal stops bleeding from vascular access sites and external wounds.
BioSeal can be used on a port placement or removal site if it continues to bleed after sutures are placed. BioSeal
Powder can be placed directly on top of the sutures.
Can BioSeal be placed in a tunneled access tract to stop bleeding?
This would be considered off label use. BioSeal is not approved for internal use. BioSeal has been effective at stopping
bleeding when applied around the tunneled access site.
Nosebleed
Can I use PRO QR for Nosebleeds for a posterior nosebleed?
PRO QR Powder for Nosebleeds (with applicator) is indicated for anterior nosebleeds, which represent the 90% of
nosebleeds that take place in the lower, two-thirds of the nose. Nosebleeds that occur in the upper posterior require
other treatment approaches as directed by a medical professional. PRO QR Powder is currently not indicated for
posterior nosebleeds.
What is the applicator included with PRO QR for Nosebleeds made of?
The applicator is made of a special microfiber, specifically chenille. It loads and releases eight times more powder than
a standard cotton swab.
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