HemCon Bandage 1.5 x.1.5

By: Hemcon  11-11-2011
Keywords: Blood Cells, Antibacterial Barrier

Frequently Asked Questions

For Hemostatic HemCon Product Use in the Cath, IR or EP Labs

What was the impetus for the development of the HemCon Bandage Product Line?

Out of a need to save lives, HemCon Bandages were developed. In 2001, the U.S. Army and the Institute for Surgical Research (ISR) partnered with HemCon Medical Technologies, Inc. to address the needs of soldiers who were having bleeding issues and dying in the field before they could be triaged for surgical intervention. 

How do HemCon Bandages work at the puncture site?

HemCon products are fabricated from chitosan, a naturally occurring, biocompatible polysaccharide. The chitosan has a positive charge, and attracts red blood cells, which have a negative charge. The red blood cells and platelets are drawn towards the bandage through this ionic interaction, a strong seal is formed at the dermal wound site. This supportive, primary seal allows the body to effectively activate its coagulation pathway, initially forming organized platelets.  The platelets and red blood cells continue to be drawn towards the bandage and travel up the access tract to strengthen the initial seal. After hemostasis is achieved, a transparent dressing will keep the HemCon Bandage in place, allowing it to provide an antibacterial barrier.

What are the benefits of using HemCon?

HemCon bandages have an antibacterial barrier, provide quick hemostasis, are effective on anticoagulated patients, and are cost effective.

Why is an antibacterial barrier important?

According to the CDC, infection occurs in femoral access sites 0.5% and happens more often with the use of a vascular closure device. Though not a high percentage, Medicare will stop reimbursing for hospital care given for hospital-acquired staph infections beginning Oct 1, 2007. The HemCon Bandage products are cleared with an antibacterial barrier indication against a wide range of harmful organisms, including the antibiotic-resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), Acinetobacter baumannii and pseudomonas aeruginosa.  Only single strains of species mentioned have been studied.

How do I apply HemCon Bandages on Cath/IR/EP patients?

1.       Remove the sheath following hospital protocol.

2.       Allow a small amount of blood to surround the puncture site. Do not cleanse the puncture site or moisten with saline solution. Blood is required to facilitate the unique adhesion process and bandage will only adhere where blood was present.

3.       With printed side facing up, place the HemCon bandage directly on the puncture site. 

4.       Hold digital pressure across the entire vascular access tract until bleeding is controlled. .

Note: It is important that pressure is held over the puncture in the vessel which is proximal to the puncture site on the skin.

5.       After hemostasis is achieved, secure the HemCon bandage with an appropriate dressing.

6.       Recheck the wound for potential rebleeding as necessary.

The bandage may not have sealed around the wound site if:

·         Adequate blood was not present.
When applying HemCon Bandages, the skin area needs to be dry with the exception of the blood (approx. 25mm diameter) that needs to be present to activate chitosan and create a seal on the wound.

·         There was no/minimal pressure applied, even though the bandage was in contact with blood .
Direct pressure is needed for a minimum of 2 to 5 minutes.

Longer direct pressure is recommended with more complicated patients and procedures.

·         The bandage was lifted, which un-sealed the bandage.  

       -  The bandage may not "reseal" after the bandage is lifted/removed. 

              -     If hemostasis was not achieved, reapply a new bandage and hold 
pressure until bleeding is controlled.

        - If hemostasis has been achieved, hold dressing in place with an 
appropriate dressing to act as an antibacterial barrier.

How long should I hold pressure when using HemCon on cath lab patients?

HemCon is helping many labs reduce their hold times. You should follow your institution’s protocol until you are comfortable reducing hold times. Many cath labs find that with uncompromised patients, 5 minutes holds are adequate. However, this guideline should not supersede clinical judgment based on the medical condition of the individual patient.

When should I ambulate my patients using HemCon?

You should follow your institution’s manual compression protocol for ambulation times. General clinical recommendations are 2-6 hours.

General Recommendations Regarding Post-procedural Hemostasis after Femoral Artery Access Using Manual Compression Only

Following removal of femoral arterial sheath

Recommendation

             ACT

< 175 seconds

             Manual Compression

10-20 minutes (until hemostasis is achieved)

             Ambulation

2-6 hours


ACC/SCA&I Expert Consensus Document on Cath Lab Standards, JACC Vol. 37, No. 8, 2001

Protocol for Madigan Army Medical Center- Ft. Lewis, WA

“These hold times are on the conservative side when using the HemCon adjunct. We have had high success rates with shorter hold times. I would recommend these as a start points and allow personal experience to guide your judgment.”

Situation

Recommendation

ACT Level for Sheath Removal

ACT not recorded prior to sheath pull

6 FR Sheath Removal

·    6 FR sheath single stick with HemCon; 5-8 minutes.

·    6 FR sheath single stick without HemCon; 12-15 minutes.

·    6 FR sheath multiple stick attempts to gain access with HemCon hold time 8-12 minutes.

·    6 FR sheath multiple stick attempts to gain access without HemCon 20 minutes.

8 FR Sheath Removal

·    8 FR stick with HemCon - 8-12 minutes.

·    8 FR single stick without Hemcon - 18-24 minutes.

·    8 FR sheath multiple stick attempts to gain access with HemCon -10-15 minutes.

·    8 FR sheath multiple stick attempts to gain access without HemCon - 24-30 minutes.

Ambulation

2-4 hours

Can HemCon Bandages be used on obese patients?

Our products are not contra-indicated for use on obese patients. However, medical professionals should use their clinical judgment and follow department protocols when treating this patient population.  

Will the HemCon’s Bandage or Patch increase hematoma formations?

Is the bandage effective after hemostasis is achieved?

After initial hemostasis is achieved, the bandage can remain in place for up to 48 hours. During this time, the HemCon Patch provides an effective antibacterial barrier against a wide range of microorganisms including MRSA, VRE,  A. baumannii and pseudomonas aeruginosa. This barrier may help prevent the risk of infection. You should follow hospital protocols for ambulation and recheck the wound for re-bleeding due to changing patient conditions.

How long should I leave the HemCon Bandage on?

The HemCon bandage can be left in place for 24-48 hours. 

How are HemCon Bandages removed?  

To remove the bandage, irrigate with sterile water or saline while gently pulling up on the corner of the bandage. Instruct discharged patients to soak the bandage in the shower, and then gently peel off the bandage.

Are there any contraindications for its use?

There are no known contraindications for use of HemCon Bandages. The warning and cautions on our product labels read as follows: 

Do not use if seal is broken and/or contents are wet. Do not apply over eyes. Use promptly after opening. Contains chitosan from shellfish. For external use only, do not implant. Not for consumption, do not eat. Single use only. Do not resterilize.

Are HemCon Bandages absorbent?

HemCon Bandages Are not absorbent and will not absorb moisture. Instead of absorbing, the bandage is designed to effectively seal the wound and stop the bleeding.

From what are HemCon Bandages comprised?

HemCon Bandages are fabricated from of chitosan, a naturally occurring, biocompatible polysaccharide derived from shrimp shells. The shrimp shells are processed and chemically treated. Once in bandage form, they are sterilized.  Pandalus borealis (also called Pandalus eous) is the species of shrimp found in cold parts of the North Atlantic Ocean that is used in our chitosan.

Is there a problem using this product on people with shrimp or shellfish allergies?

There have been no known allergic reactions as a result of using HemCon Bandages since distribution began in 2003, and there have been no adverse effects reported after over one million of our dressings in various sizes have been delivered and used all over the world. 

HemCon has results from a shellfish allergy study conducted by its chitosan supplier which demonstrates that, out of 221 individuals with suspected hypersensitivity, including 8 individuals with known shellfish allergies, none demonstrated any dermal sensitivity when pricked with a chitosan test solution. However, since chitosan is extracted from the shells of shrimp and other shellfish, individuals with known shellfish allergies should exercise caution in the use of products containing chitosan.

Are HemCon Bandages kosher?

HemCon Bandages are made from shellfish, a creature that is considered forbidden from consumption by some religious groups. Although the bandage is not technically consumed, it is not considered kosher.

Is there any effect of hot temperatures on HemCon Bandages?

HemCon Bandages have a long shelf life and are durable in varied temperature because they were originally designed for military use. HemCon Bandages are best stored at room temperature: 52° F (11° C) to 78° F
(26° C).

Keywords: Antibacterial Barrier, Blood Cells,

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