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FAQ

How should the ulcer be prepared before applying the 3C Patch®?

Before the first treatment, it is recommended to remove necrotic tissue by sharp debridement, using a curette or scalpel, to obtain fresh tissue and bleeding. After debriding, rinse and/or swab until bleeding has stopped.

On subsequent treatments, rinse with water and remove any loose residual 3C Patch®. If the 3C Patch® is integrated into the newly formed granulation tissue, do not remove it.

If the wound area has not changed over a few weeks, it may be necessary to perform another debridement before 3C Patch® is placed on the wound.

How many 3C Patch® treatments are needed?

This varies from patient to patient and from wound to wound and there is no definitive answer.

Data from the Cohort study (Wagner Grade I and II DFU) gave a mean treatment time to healing of 11 weeks (11 weekly treatments) with a range of 3-20 weeks.2

Data from the RCT on hard-to-heal diabetic foot ulcers gave a mean treatment time of 10 weeks to healing.1

Is there a maximum number of applications?

We recommend continuing treatment as long as you can see an effect of 3C Patch® treatment every week. If no effect is observed after 6 weeks of treatment, we recommend discontinuing treatment.

Can the 3C Patch® come into contact with intact skin?

Yes. A 3C Patch® can come into contact with intact skin and will simply dry out in that area during the week. Please be aware that 3C Patch® must have direct contact with the wound bed.

What if the 3C Patch® is very moist?

Gently place the 3C Patch® with the concentrated cells facing upwards on an absorbent sterile layer to remove excess moisture before placing in the wound. Do not place the side of the patch with the concentrated cells in contact with the absorbent pad or you will risk limiting the contents of the patch.

What if the patch appears to be very thick?

Check if the filter is all the way at the top of the device, if not then repeat the second centrifugation in the “two dots” position.

What if the patch is very thin?

A thin patch can be used without any issues.

Can I treat deep ulcers or ulcers with exposed tendons or bone contact?

Yes. However, be sure that the 3C Patch® is placed on a clean well-debrided wound bed.

You can also place a part of the patch in the bottom of the wound with the rest of the 3C Patch® up the sides.

What if the surrounding skin is macerated?

Maceration implies that you need to change the secondary dressing more often to control the moisture balance. The preference is for moist wound healing and not wet wound healing; always refer to your own clinical procedures for moist wound healing.

What is the correct way to place 3C Patch® into the wound?

The side of the 3C Patch® facing the filter is the side that must be facing downwards in contact with the ulcer. This is the side with the concentrated cells.

Can the 3C Patch® be cut into shape so it fits to the ulcer?

Yes. The best way to cut the patch is to place the patch on a sterile absorbent layer with the cells up and cut through this layer and the patch at the same time using sterile scissors. This makes cutting and handling the patch very easy.

How is the primary bandage applied?

Cut the primary (non-adherent) dressing to the right size so that the border is approximately 1 cm around the 3C Patch® and place tape (e.g. micropore tape) around the edges to secure it. This will ensure that the 3C Patch® stays in place in the wound.

Do not cover the entire primary dressing with tape, as wound fluid needs to be able to pass.

Do not remove the primary dressing between the weekly treatments at the hospital/clinic.

It is acceptable to lift the dressing and observe for infection in the wound during the week and of course replace the secondary dressing if needed.

Can silver dressings be used as a primary dressing?

Yes. It is possible to use silver dressings together with the 3C Patch®.

Some nurses have reported that they prefer to use a silver primary dressing because they report that it prevents odour occasionally coming from the wound.

Which secondary dressing can be used with 3C Patch®?

Any secondary moist wound dressing can be used. It is up to each clinician to choose the right dressing for exudate management and ensure good moist wound dressing practice.

How often should the secondary dressing be changed?

The frequency of changing the secondary dressing depends on the amount of exudate and maceration and is at the discretion of the clinician. However, it is important to keep an eye on any changes in exudate levels – and change the secondary dressing accordingly.

Can the patient take a bath between the treatment weeks?

Yes, but be aware that the primary dressing must not become wet.

Instruct the patient that if the dressing gets wet they should contact the nurse at the hospital and ask what to do. If the 3C Patch® has been placed in the wound for 3-4 days then remove the primary dressing and replace it with an appropriate absorbent dressing until the next weekly hospital visit takes place.

Can a compression bandage be combined with 3C Patch®?

Yes, it is possible to use 3C Patch® together with compression therapy. However, it is important to keep an eye on any changes in exudate levels – and change the secondary dressing accordingly.

How often can an ulcer be treated with 3C Patch®?

In the clinical trials the patients were treated weekly, but outside trials the treatment period is up to the clinician.1-3

Can the 3C Patch® be stored or refrigerated?

No the 3C Patch® should not be stored, or refrigerated The 3C Patch® must be stored at room temperature until use and applied within 1 hour.

What is the patient selection criteria for using 3C Patch®?

3C Patch® is cleared by the FDA for the management of exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically debrided wounds.

Can NWPT (negative wound pressure therapy) be combined with 3C Patch®?

Yes. We are aware that some of our users have done this and it is possible, but currently we only have experience from a few cases. Deciding to combine 3C Patch® with NWPT is done at the discretion of the clinician.

No blood is drawn

Ensure that proper vein access has been obtained before. Always follow your clinical procedures for drawing blood.

WHAT HAPPENS IF THE DEVICE IS NOT COMPLETELY FILLED?

If the device has not been completely filled with blood it can cause problems detecting coagulation. The 3CP® Centrifuge sensors estimate coagulation in the upper part of the device during the centrifugation process. If there is no blood in the top of the device the automatic process cannot take place – and the centrifuge will go to manual mode.

In the 3CP® Centrifuge User manual you can find photos demonstrating an acceptable fill level.

WHAT HAPPENS IF THE DEVICE BECOMES SEPARATED FROM THE NEEDLE HOLDER?

If the device has not been properly turned to the locking position in the needle holder it may be pushed out of the needle holder. This may result in less blood being filled into device.

Be certain to lock the device in place when filling the device. It is better to allow more time to fill than to end the filling too soon. The device cannot be overfilled so wait until it stops filling before removing it from the needle holder.

How soon after drawing the blood sample should centrifugation begin?

It is important to start the centrifugation within 5 minutes of drawing the blood – before the coagulation starts to take place. The 3CP® System does not contain additives e.g. no anti-coagulants, therefore, it is very important to separate the cells before the natural coagulation process starts.

The first high-speed centrifugation must take place before coagulation and the final centrifugation takes place after coagulation.

What is the difference between placing the device in the “one dot” or the “two dots” position in the centrifuge cups?

In the “one dot” position in the centrifuge cup, the filter is held in the bottom of the device and in the “two dots” position the filter is allowed to float to the top of the device to compact the fibrin clot and form the 3-layered patch. It is of key importance to start the process by placing the device in the “one dot” position.

What happens if the process is stopped during the first centrifugation spin?

If you stop the process during the first centrifugation spin, ensure that you replace the device into the centrifuge cup at the one dot mark before you restart the centrifugation. It is important to check this, because the centrifuge cup is designed so that the device will automatically turn to the “two dot” position after any centrifugation.

If the device is not positioned in the “one dot” position for the first spin, then the device cannot turn automatically and a patch will not be prepared.

Please also be aware that the STOP button will reset the memory so the process will start from the beginning with an 8-minute spin.

What if the centrifuge gives the message “Imbalance”?

Find the cause for the imbalance message.

The 3CP® Device may have been pressed too hard into the centrifuge cup and may have activated the imbalance sensor. The imbalance sensor is located in the left side and it can be quite sensitive.

If you are only centrifuging one device confirm that you have placed the 3CP® Device and the 3CP® counter balance directly opposite each other.

Check if the 3CP® Device is significantly under-filled and does not weigh the same (+/- 5 g) as the 3CP® counter balance. If this happens, you will need to fill an empty device with the appropriate amount of water to counterbalance the under filled device.

You must turn off the external power supply before the message in the display will disappear. For more information see the 3CP® Centrifuge User Manual.

What if the centrifuge stops immediately after starting?

Check that you have the right balance in the centrifuge. There should be two 3CP® Devices directly opposite each other or one 3CP® Device with a 3CP® counter balance directly opposite it.

Check that blood is filled to the same level in both devices.

What if the 3CP® Device cannot be placed into the “one dot” track?

Check that the inner spring in the centrifuge cup is clicked into the correct position. The correct position is upright and attached to the bottom.

What if the filter has not completely raised to the top of the device during the second centrifugation?

If the filter is not at the top, the devices should be repositioned in the “two dots” position and the centrifuge continued by pressing, “START”.

In rare cases, the 3CP® Centrifuge will fail to detect that the filter is not at the top and it will end the process – in this case the device should be repositioned in the “two dots” position and the centrifuge started by pressing “START”; this will start an 8-minute spin cycle which should be stopped manually after approximately 2 minutes to inspect if the filter comes up.

What if there is no 3C Patch® in the device after processing?

The main reason could be the device has been placed in the “two-dots” position from the beginning and the filter has moved to the top of the device during the first spin e.g. before coagulation took place.

If the filter is at the top of the device but no 3C Patch® is present, the coagulation process did not complete before the second spin and no 3C Patch® will be available. In this situation, to obtain a patch, a new device is needed and the complete process, including a new blood sample, must be repeated.

In rare cases, user inspection is required when the centrifuge is not able to automatically detect coagulation and reads: “Coagulation Not Complete” or “Opaque Plasma.”

Pay attention to coagulation and wait longer with the 3CP® Device in the centrifuge with the lid closed to keep heat in and aid coagulation. Wait as needed and re-check that coagulation has occurred before undertaking the final 2-minute spin.

Does anticoagulant medication affect the coagulation?

Yes, if the INR (International Normalized Ratio (coagulation status)) value is affected this usually means that the coagulation process time is prolonged.

Why does the 3C Patch® appear different from patient to patient?

The 3C Patch® may differ in appearance from patient to patient and from sample to sample but is usable regardless of whether it appears yellow, red or pale.

What if there is a leakage in the centrifuge?

If there is leak from the 3C Patch® Device during the centrifugation steps it is essential to carry out appropriate cleaning and decontamination according to local regulations and as described in the provided centrifuge manual.

The cleaning should include unplugging the power cord, removing the rotor from the centrifuge and cleaning all components and the bowl with a mild cleaning agent followed by disinfection with alcohol based disinfectants and always in accordance with local regulations.

If there is a leakage in the centrifuge, fill out and submit a complaint form, and if you need to send the centrifuge for service you need to fill out a decontamination certificate and attach this to the centrifuge.

What if the lid of the centrifuge will not open?

In case of power failure, or a “Lid Error” message in the display, the centrifuge can be opened using the emergency lid release feature.

Insert the 3 mm Allen key, provided in the tool bag, into the front of the centrifuge (see 3CP Centrifuge User Manual section 5.8) and turn counter-clock wise. This will open the centrifuge.

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