PERSONALIZED WOUND HEALING

THE PATCH THAT USES YOUR BLOOD – TO HEAL YOUR WOUND

5 Reasons why 3C Patch® is leading the race in Advanced Wound Care

100% autologous
Entirely alive
Remarkably simple
Immediately available
Completely proven

3C Patch® is an advanced wound care solution made from the patient’s own blood at the point of care. 3C Patch is 100% autologous, contains living cells, and is clinically proven to significantly increase the chance of healing. [1] [2]

3C PATCH® EXPLAINED

100% Autologous

Entirely alive

Remarkably simple

Immediately available

Completely proven

PERSONAL WOUND HEALING

The only 100% autologous wound care patch available

3C Patch® is a 100% autologous wound care product, meaning that 3C Patch® is created entirely from the patient’s blood without adding any reagents or additives. Therefore, there is no risk for the body rejecting the 3C Patch®.

The proprietary centrifugation process creates a robust 3-layer patch containing fibrin, platelets, and leukocytes.

EXPLORE THE KIT

Wound healing patch containing live cells

98% OF THE PLATELETS ARE RECOVERED

Entirely alive

3C Patch® contains living cells, which only a few other cellular and tissue-based wound care products do. In-vitro studies have shown that 3C Patch® is a biological wound care construct containing living cells such as leukocytes and platelets, cells that are known to fight infection and support healing. The living cells in 3C Patch® are actively responding to the wound environment.

MICROSCOPE RECORDING

READY IN ONLY 20 MINUTES

Remarkably simple

The process of creating a 3C Patch® is remarkably simple and it’s based on the automated, fully integrated 3C Patch® System. 18 ml. of blood is drawn by venipuncture into the 3C Patch® Device. The device is placed into the 3CP Centrifuge, a table-top centrifuge that spins the blood for approx. 20 minutes. After the centrifugation is finished, the 3C Patch® ready to be transferred onto the wound.

WATCH HOW IT'S MADE

ON-SITE AUTOMATED PROCESS

Immediately available

3C Patch® is a point-of-care regenerative medicine. Other wound care products containing living cells require storage at certain temperatures and may require shipping patient-derived tissue for external processing before receiving a finished product for wound application. The process may take days or weeks, needs planning, attention and is prone to logistical issues.

3C Patch® is created in 15-20 minutes through a completely automated centrifugation process, at the end of which the 3C Patch® is ready to be transferred onto the patient’s wound.

CLINICAL PRACTICE

COMPLETELY PROVEN

Significantly increasing the chances of healing

3C Patch® is backed by extensive clinical research, including a large (n=269), international, multicentre, observer-blind, randomized controlled trial published in the Lancet. The results showed an 89% improved chance of healing of difficult to heal diabetic foot ulcers. A pilot study (n=44) published in the Journal of Wound Care showed a 127% improvement compared to a matched control group [1] [2] [3]

Read more about the clinical data that supports the effectiveness of 3C Patch as an advanced wound management solution.

3C Patch® Mode of Action

Watch the video explaining everything

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WANT TO KNOW HOW IT WORKS IN REAL LIFE?

3C Patch® is not a wound care dressing – it’s an advanced wound care procedure done by the provider at the point-of-care

The primary function of a wound dressing is to cover and protect the wound while the body goes through the healing process.

By comparison, using a 3C Patch® is like getting “a blood transfusion for your wound.” All the healing components from the blood are reformulated through an automatic centrifugation process into a 3-layered patch containing approx. 50 million leukocytes known to fight infection, 3 billion platelets having high growth factor levels, and fibrin, which provides moisture retention, structural integrity and makes it easy to handle.

PATIENT COMPLIANCE

How do patients react to having 3C Patch® as their wound care treatment

Clinical practice data shows that patients respond positively to having their blood taken and transformed into their wound treatment.

Furthermore, the randomized controlled trial results reported no device-related serious events, no differences in adverse events or serious adverse events between the control group and the 3C Patch® group, and no differences in new anemia between groups, despite weekly blood sampling in the 3C Patch group.

“Patients understood a logic model behind the treatment. The concept of their own blood being used to form a patch full of active cells, which helps heal their wound, helped with buy-in and compliance. “

Nikki Drake and Nicola Percy

Advanced Podiatry Practitioners

“On speaking to people on their willingness to participate in the trial, the comments were largely positive, and they were intrigued about trying such a novel way of treating their foot ulcer.”

Alison Musgrove

Advanced Podiatrist

“When patients are seeing improvement and healing in ulcers that have been present for years or report a 50% reduction in their pain after the first application, there are smiles all around.”

Dr. Martin Johnson

Plastic surgeon

What are the main criteria for adding a new advanced wound care product in your clinic?

When talking to healthcare providers about selecting a new advanced wound care treatment to be added to their practice portfolio, four key factors emerged as the most influential

The science behind the product
The validity of the clinical data
Availability and implementation
Cost and reimbursement

Science and mode of action of 3C Patch®

Blood plays an essential role in wound healing. Arteriovenous shunting is a vital part of this process. In the normal healing response, the arteriovenous (AV) shunts contract, forcing blood through the capillaries to the wound site.

In people with diabetes, continuous high blood glucose levels lead to neuropathy. This results in non-functional AV-shunting and impaired microvascular flow, which causes chronic capillary ischemia. When the AV shunts become denervated, they lose their contraction response and stay open. This stalls the inflammatory response – which is key to healing – and prevents a sufficient number of immune cells, platelets, growth factors, and other signaling substances necessary for healing from reaching the wound.

Applied directly to the wound surface, 3C Patch® provides a high concentration of fibrin, leukocytes, and platelets. Fibrin provides moisture retention; leukocytes are known to fight infection, while platelets are known to provide high growth factor levels and participate in the resolution of inflammation.

Clinical data

A randomized controlled trial is usually acknowledged as the most robust study design for testing the efficiency and safety of a new drug, biologics, or medical device. There are only a handful of cellular and tissue-based products whose effectiveness is supported by a randomized controlled trial.

3C Patch RCT Study design:

• An independent multicenter, multinational, observer-blind, investigator-driven Randomized Controlled Trial on patients with hard-to-heal Wagner grade 1-3 DFUs

Intervention:

• 3C Patch® was applied once a week for up to 20 treatments, or until the target ulcer was completely epithelized.

In the first treatment session, the ulcer was sharp debrided before one or two patches were transferred to the ulcer, which was then covered by a primary dressing. Secondary bandages were applied as decided on a case-by-case basis and changed depending on exudate levels

Patients:

• 269 patients were randomized

• “Hard-to-heal” defined rigorously as having DFUs that did not reduce in area more than 50% over a 4-week run-in period despite best standard of care according to IGWDF (incl. ref) guidelines 2019 including debridement, offloading etc. as appropriate

• The groups were well matched at baseline and consisted of those in most need of new treatment, those with “hard-to-heal” DFUs

Availability and implementation

3C Patch® is immediately available at the point of care. To create a 3C Patch® you need to follow the procedure described in the next steps:

1. 18 ml of the patient’s blood is drawn into a 3C Patch® Device by venipuncture

Wound care product made from the patient's blood

2. The filled 3C Patch® Device is placed into the 3CP® Centrifuge; the process is entirely automated

3. After 15-20 minutes, the 3C Patch® is generated and transferred to the wound

Application of 3C Patch® wound treatment

Easy to use and fits well within the clinic’s workflow

The 3C Patch® System is relatively easy to use and fits well within the clinic’s workflow. For the process to run smoothly, you need a nurse who is comfortable drawing blood, and additional time should be scheduled for difficult blood draws. While the blood sample is in the centrifuge, you can use that time to debride the wound and educate the patient about the standard of care guidelines applicable to his or her condition.

Cost and reimbursement

3C Patch® System is an FDA-cleared advanced wound management solution currently covered by CMS in all 50 States in the US. If you would like more details about the product cost and reimbursement, please contact us.

FAQ

Frequently asked questions

Read all questions in our 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 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.

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 applications are not unusual to create new granulation tissue.

Can I treat deep ulcers, interdigital ulcers, or ulcers with exposed tendons/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 cut the 3C Patch® into shape so it fits 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.

[1] Löndahl, M., Tarnow, L., Karlsmark, T., Lundquist, R., Nielsen, A. M., Michelsen, M., Jørgensen, B. (2015). Use of an autologous leucocyte and platelet rich fibrin patch on hard-to-heal DFUs: a pilot study. Journal of Wound Care, 24(4), 172–8.

[2] Game F., Jeffcoate W., Tarnow L., Jacobsen JL., Whitham DJ., Harrison EF., Ellender SJ., Fitzsimmons D., Löndahl M., LeucoPatch system for the management of hard-to-heal diabetic foot ulcers in the UK, Denmark, and Sweden: an observer-masked randomized controlled trial. Lancet Diabetes Endocrinol. 2018;6(11):870-878.

[3] Lundquist, Jørgensen, Fagher, Löndahl (2015). 3C Patch™ – an adaptive triple layered autologous platelet and leukocyte rich fibrin patch and its clinical use in the treatment of hard-to-heal diabetic foot ulcers. Poster, Innovations in Wound Healing 2015.