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FAQ
HOW DO I PREPARE THE ULCER BEFORE APPLYING THE 3C PATCH®?
Before the first treatment, it is recommended to perform a thorough sharp debridement (with curette or scalpel to fresh tissue and bleeding) and to remove necrotic tissue.
After debriding, rinse, and/or swab until any 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 the 3C Patch® is placed on the wound.
WHAT SIZE OF ULCER CAN I TREAT?
There is no minimum size. Each device produces a 5cm² patch. The patch can be cut to size to treat smaller wounds.
HOW MANY 3C PATCH® TREATMENTS ARE NEEDED?
This varies from patient to patient and from wound to wound. In general, you can expect to see an effect after 2-3 applications.
Data from our 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.
Data from the RCT study gave a mean treatment time of 10 weeks to healing, so 6-8 or more applications are not unusual to create new granulation tissue.
IS THERE A MAXIMUM NUMBER OF APPLICATIONS?
If you have seen no effect after 6 weeks of treatment, we recommend pausing or stopping the 3C Patch® treatment.
We recommend continuing the 3C Patch® treatment as long as you can see an effect from the 3C Patch® treatment every week.
We recommend continuing the 3C Patch® treatment as long as you can see an effect from the 3C Patch® treatment every week.
CAN THE 3C PATCH® COME INTO CONTACT WITH INTACT SKIN?
Yes, no problem. 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 contact with the wound bed.
WHAT DO I DO IF THE 3C PATCH® IS VERY MOIST?
Place the 3C Patch® with the active cell layer facing upwards on an absorbent sterile layer before placing it in the wound.
WHAT DO I DO IF THE 3C PATCH® IS VERY THICK?
Check if the filter is right at the top of the device, if not, repeat the second centrifugation in the two dots mark position before removing the lid.
WHAT DO I DO IF THE 3C PATCH® IS VERY THIN?
A thin patch can be used without any issues. It is caused by lower fibrin levels, which vary from person to person.
CAN I TREAT DEEP ULCERS, INTERDIGITAL ULCERS OR ULCERS WITH EXPOSED TENDONS OR BONE CONTACT?
Yes, just be sure that the 3C Patch® is placed on a clean well-debrided wound bed, and no osteomyelitis is present. You can also place a part of the patch at the bottom of the wound with the rest of the 3C Patch® up the sides. It is important to stimulate the growth of the ulcer from the bottom.
CAN I USE SEVERAL LAYERS OF 3C PATCH® ON TOP OF EACH OTHER IN DEEP ULCERS?
Yes, it is possible, just make sure that the innermost 3C Patch® is in contact with the wound bed. The frequency of changing the secondary bandage might be higher than usual. While the primary dressing provided in the 3C Patch® Kit should be secured and left undisturbed for a minimum of 5-7 days, the secondary dressing may be changed more frequently, as needed, based on wound drainage volumes.
WHAT DO I DO IF THE ULCER IS UNDERMINED?
If you don’t want to cut it open, then try to measure the depth of the undermining and place the 3C Patch®, or a part of the 3C Patch® beneath it.
IF THE PERIWOUND SKIN IS MACERATED, WHAT DO I DO?
Avoid leaving an over-saturated secondary dressing in place, as this will result in poor 3C Patch® therapy results. You should increase secondary dressing changes and/or select a more
absorbent secondary dressing. The goal is to create a moist wound healing environment while avoiding too much moisture or even wetness.
absorbent secondary dressing. The goal is to create a moist wound healing environment while avoiding too much moisture or even wetness.
HOW DO I PLACE 3C PATCH® INTO THE WOUND?
The “chequered” side of the 3C Patch® facing the filter is the side with the active cells on it, so this is the side that must face downwards in contact with the ulcer.
HOW MUCH OF THE WOUND AREA NEEDS TO BE COVERED BY 3C PATCH®?
We recommend that at least 75% of the wound surface is covered.
CAN I CUT THE 3C PATCH® INTO SHAPE SO IT FITS TO THE ULCER?
Yes, no problem: The easiest way is to place the patch on a sterile absorbent layer with the cell side up and cut through this layer and the patch at the same time. This makes cutting and handling the patch very easy.
HOW LONG WILL THE GROWTH FACTORS BE RELEASED IN THE ULCER
In Vitro data showed that growth factors are released for up to 7 days.
HOW IS THE PRIMARY BANDAGE APPLIED?
Cut the primary (non-adherent) dressing to the right size bordering approximately 1 cm around the 3C Patch® and place tape (e.g. steristrips or micropore tape) around the edges to secure it. This will ensure that the 3C Patch® stays in place in the wound.
Make sure not to cover the entire primary dressing with tape as fluid needs to be able to pass.
Do not remove this 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 to replace the secondary dressing if needed.
CAN I USE SILVER AS PRIMARY DRESSING?
Primary dressings containing silver can be used in combination with 3C Patch®.
WHICH SECONDARY DRESSING CAN BE USED?
Any secondary dressing can be used, and it is up to the clinician to choose what they want to use for exudate management and to ensure moist wound care. The secondary dressing should be selected based on wound drainage volume.
HOW OFTEN DO I HAVE TO CHANGE THE SECONDARY DRESSING?
As the 3C Patch® is an active treatment, it is important to keep an eye on any changes in exudate levels – and change the secondary dressing accordingly. You might need to increase the frequency of secondary dressing changes to avoid periwound maceration.
CAN THE PATIENT TAKE A BATH BETWEEN TREATMENTS?
Yes; however, please use water-proof protection to avoid wetting the primary and secondary dressing.
If the 3C Patch® has been placed in the wound for 3-4 days before the primary and secondary dressing is compromised, growth factors have been released. In this case, remove both dressings and replace them with a fresh absorbent dressing until the next visit to the clinic.
Please instruct the patient to notify the clinic of this occurrence.
CAN I USE NWPT (NEGATIVE WOUND PRESSURE THERAPY) COMBINED WITH 3C PATCH®?
Yes, we recommend placing the provided primary dressing prior to the NPWT foam placement to keep the 3C Patch® in place and protected.
CAN I USE A COMPRESSION BANDAGE COMBINED WITH 3C PATCH®?
Yes, it is possible to use 3C Patch® together with compression therapy. However, as 3C Patch® is an active treatment, it is important to keep an eye on any changes in exudate levels
– and change the secondary dressing accordingly.
– and change the secondary dressing accordingly.
CAN THE 3C PATCH® BE STORED OR REFRIGERATED?
No, we do not recommend storing the 3C Patch® in a refrigerator or freezer. The 3C Patch® must be stored at room temperature until use and applied within an hour.
CAN I TREAT A PATIENT WITH AN INFECTED ULCER?
We do not recommend treating ulcers that are clinically infected, according to ISDA guidelines (Infectious Diseases Society of America), but in every ulcer, bacteria will be present. However, these will not affect the 3C Patch® treatment. 3C Patch® has shown an antibacterial effect on Pseudomonas bacteria In Vitro, but should not be used as an anti-bacterial treatment. In case of infection, antibiotic treatments are warranted.
ARE THERE ANY CONDITIONS FOR WHICH TREATMENT WITH 3C PATCH® IS CONTRAINDICATED?
Yes, there are and they are slightly different in the EU and the US due to different regulatory systems and requirements. Please refer to your local IFU for a detailed overview of contraindications in your region.
WHAT IS THE TREATMENT FREQUENCY WITH 3C PATCH®?
In the clinical study, we treated the patient weekly; but outside study conditions, it is up to the clinician to decide whether to treat more often. For example, some clinicians treat hospitalized patients bi-weekly with 3C Patch® to quickly start the healing process, and switch to a weekly treatment pattern in the out-patient setting.
WHAT IS THE PATIENT SELECTION CRITERIA?
Generally, it is possible to treat different types of hard-to-heal wounds (> 4 weeks). Our RCT was designed for treating diabetic foot ulcers with 3C Patch®, and therefore our treatment guidelines and recommendations are related to this type and use.
NO BLOOD IS DRAWN INTO THE 3C PATCH® DEVICE
Ensure proper vein access has been obtained before connecting the device to the needle holder. Proper access is indicated by the presence of blood in the tubing line. If the device was connected before vein puncture, the device will have lost its vacuum and a new device will be needed.
THE DEVICE IS NOT COMPLETELY FILLED
If the device has not been completely filled with blood it can cause problems during the centrifugation process as the sensors in the centrifuge estimate coagulation in the upper part of the device during the centrifugation process. If there is no blood at 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 section 5.3.4, underfilled device, you will see photos of devices, which show which fill level is acceptable and which is not.
HOW LONG AFTER DRAWING THE BLOOD SHOULD THE CENTRIFUGATION BEGIN?
It is important to start the centrifugation soon after taking the blood in order to separate the cells before coagulation starts. Because our device contains no anti-coagulants or additives, centrifugation should be initiated within approximately 5 min. after the blood draw.
DOES WARFARIN (OR MAREVAN) AFFECT THE COAGULATION TIME?
Yes, the INR value (coagulation status) is affected and this means that usually the
coagulation is prolonged.
coagulation is prolonged.
WHAT DOES INR VALUE MEAN?
INR = International Normalized Ratio (coagulation status).
• If you have an INR of 1 the coagulation (gel-like layer) will normally form within a 10 min. coagulation phase.
• If you have an INR value of 2 it generally means that coagulation time is double.
• If you have an INR value of 3 it would generally triple the time of the coagulation phase.
DOES XARELTO (RIVAROXABAN) AFFECT THE PREPARATION OF THE 3C PATCH®?
Yes: This antithrombotic medication has a half-life of 9 hours and therefore the coagulation of the blood is usually prolonged.
If appropriate, investigate with the clinician if it is possible for the patient to delay the intake of Xarelto until after the blood sample for 3C Patch® preparation is taken.
Please note that the Xarelto treatment does not increase your INR value but coagulation could still be prolonged.
If appropriate, investigate with the clinician if it is possible for the patient to delay the intake of Xarelto until after the blood sample for 3C Patch® preparation is taken.
Please note that the Xarelto treatment does not increase your INR value but coagulation could still be prolonged.
DOES PRADAXA (DABIGATRAN) AFFECT THE PREPARATION OF THE 3C PATCH®?
Yes: This is a direct thrombin inhibitor and therefore the coagulation of the blood is usually prolonged. Please note that the Pradaxa treatment does not increase your INR value but coagulation could still be prolonged.
THE 3C PATCH® APPEARS DIFFERENT
The 3C Patch® may differ in appearance from patient to patient and from sample to sample, but it is usable regardless of whether it appears yellow, pale, or red.
CAN I RUN MORE THAN ONE PATIENT’S BLOOD AT THE SAME TIME?
In general, yes but it is not recommended. You have to ensure there is absolutely no risk of confusing the devices/patches (consult your manual on how to mark different devices correctly). And be aware that process times may differ between patients as coagulation time is individual. The overall process will therefore only finish after the longest coagulation has been completed.