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Global Regenerative Trade

MAGELLAN®

WOUND CARE

WHAT IS REGENERATIVE MEDICINE?

Regenerative Medicine encompasses many medical fields – Orthopedics and Spine Surgery, Sports Medicine, Gynecology, Urology, Oncology, Dermatology, Plastic surgery, Vascular Surgery, Cardiac surgery, etc.

Regenerative Medicine is the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues. Regenerative medicine includes the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs. It uses autologous blood, bone marrow or adipose components to stimulate the body’s own repair processes. A common source for regenerative cells and growth factors are bone marrow aspirate concentrate (BMAC), platelet rich plasma (obtained from one’s own blood) and adipose derived stem cells.

PATHOLOGY

WHAT IS WOUND?

wound is a type of injury which happens relatively quickly in which skin is torn, cut, or punctured (an open wound), or where blunt force trauma causes a contusion (a closed wound). In pathology, it specifically refers to a sharp injury which damages the Epidermis of the skin.

According to level of contamination, a wound can be classified as:

  • Clean wound – made under sterile conditions where there are no organisms present, and the skin is likely to heal without complications.
  • Contaminated wound – usually resulting from accidental injury; there are pathogenic organisms and foreign bodies in the wound.
  • Infected wound – the wound has pathogenic organisms present and multiplying, exhibiting clinical signs of infection (yellow appearance, soreness, redness, oozing pus).
  • Colonized wound – a chronic situation, containing pathogenic organisms, difficult to heal (i.e. bedsore).

Open

Open wounds can be classified according to the object that caused the wound:

  • Incisions or incised wounds – caused by a clean, sharp-edged object such as a knife, razor, or glass splinter.
  • Lacerations – irregular tear-like wounds caused by some blunt trauma. Lacerations and incisions may appear linear (regular) or stellate (irregular). The term laceration is commonly misused in reference to incisions.
  • Abrasions (grazes) – superficial wounds in which the topmost layer of the skin (the epidermis) is scraped off. Abrasions are often caused by a sliding fall onto a rough surface such as asphalt, tree bark or concrete.
  • Avulsions – injuries in which a body structure is forcibly detached from its normal point of insertion. A type of amputation where the extremity is pulled off rather than cut off. When used in reference to skin avulsions, the term ‘degloving’ is also sometimes used as a synonym.
  • Puncture wounds – caused by an object puncturing the skin, such as a splinter, nail or needle.
  • Penetration wounds – caused by an object such as a knife entering and coming out from the skin.
  • Gunshot wounds – caused by a bullet or similar projectile driving into or through the body. There may be two wounds, one at the site of entry and one at the site of exit, generally referred to as a “through-and-through.”

Closed

Closed wounds have fewer categories, but are just as dangerous as open wounds:

  • Hematomas (or blood tumor) – caused by damage to a blood vessel that in turn causes blood to collect under the skin.
    • Hematomas that originate from internal blood vessel pathology are petechiae, purpura, and ecchymosis. The different classifications are based on size.
    • Hematomas that originate from an external source of trauma are contusions, also commonly called bruises.
  • Crush injury – caused by a great or extreme amount of force applied over a long period of time.
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Complications

 
The patient has a deep wound at the knee, and radiography is used to ensure there are no hidden bone fractures.

Bacterial infection of wound can impede the healing process and lead to life-threatening complications. Scientists at Sheffield University have used light to rapidly detect the presence of bacteria, by developing a portable kit in which specially designed molecules emit a light signal when bound to bacteria. Current laboratory-based detection of bacteria can take hours or days.

Workup

Wounds that are not healing should be investigated to find the causes; many microbiological agents may be responsible. The basic workup includes evaluating the wound, its extent and severity. Cultures are usually obtained both from the wound site and blood. X-rays are obtained and a tetanus shot may be administered if there is any doubt about prior vaccination.[3]

Chronic

Non-healing wounds of the diabetic foot are considered one of the most significant complications of diabetes, representing a major worldwide medical, social, and economic burden that greatly affects patient quality of life. Almost 24 million Americans—one in every twelve—are diabetic and the disease is causing widespread disability and death at an epidemic pace, according to the Centers for Disease Control and Prevention. Of those with diabetes, 6.5 million are estimated to suffer with chronic or non-healing wounds. Associated with inadequate circulation, poorly functioning veins, and immobility, non-healing wounds occur most frequently in the elderly and in people with diabetes—populations that are sharply rising as the nation ages and chronic diseases increase.

Although diabetes can ravage the body in many ways, non-healing ulcers on the feet and lower legs are common outward manifestations of the disease. Also, diabetics often suffer from nerve damage in their feet and legs, allowing small wounds or irritations to develop without awareness. Given the abnormalities of the microvasculature and other side effects of diabetes, these wounds take a long time to heal and require a specialized treatment approach for proper healing.

SUPPORTING EVIDENCE

  1. Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System

  2. Impacts of bone marrow aspirate and peripheral blood derived platelet-rich plasma on the wound healing in chronic ischaemic limb

  3. BMAC critical limb ischemia 
  4. A Retrospective Look at Integrating a Novel Regenerative Medicine Approach in Plastic Limb Reconstruction

       5.Englert S, et al. Autologous platelet gel applications during cardiovascular surgery: effect on wound healingJECT. 2005;37:148–152.
 
      6. Hom D, et al. The healing effects of autologous platelet gel on acute human skin woundsArch Facial Plast Surg. 2007; 9(3):174-83.                doi: 10.1001/archfaci.9.3.174
 
      7. Kakudo N, et al. The use of autologous platelet-rich plasma in the treatment of intractable skin ulcer: A case seriesOpen Journal of                   Regenerative Medicine. 2012; 01(03):29-32. doi: 10.4236/ojrm.2012.13005
 
      8. Litmathe J, et al. The use of autologous platelet gel (APG) for high-risk patients in cardiac surgery – is it beneficial? Perfusion. 2009. 24(6):381-7. doi: 10.1177/0267659109358283
 
      9. Patel AN, et al. Evaluation of autologous platelet rich plasma for cardiac surgery: outcome analysis of 2000 patientsJ Cardiothorac Surg. 2016. 11(1):62. doi: 10.1186/s13019-016-0452-9
 
      10. Saratzis N, et al. Non-activated autologous platelet-rich plasma for the prevention of inguinal wound-related complications after endovascular repair of abdominal aortic aneurysmsJ Extra Corpor Technol. 2008; 40(1):52-6.
 
       11.Vang S, et al. Autologous platelet gel in coronary artery bypass grafting: effects on surgical wound healingJECT. 2007;39:31–38.

VIDEOS

Vivostat Logo

THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS:

  • The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.
  • The Processor Unit is used to process the patient’s blood and prepare the Vivostat® Fibrin Sealant or Vivostat PRF® solution.
Vivostat Processor Product
  • The Processor Unit is operated by a single button and a display keeps the nurse informed of the remaining process time and status at all times. No specific installation is required and the large wheelbase makes moving it easy.
  • The Processor Unit can be located in any room or corridor in the operating department. It is most often placed centrally between the operating theatres. This way one Processor Unit can supply a number of operating theatres.
  • In approx.  25 min a concentrated fibrin sealant or PRF® solution is prepared from the patient’s whole blood.
  • The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® Fibrin Sealant or Vivostat PRF®.
Vivostat Processor Product
  • The large display and integrated microprocessor automatically primes the Spraypen® and informs the surgeon of the remaining volume of fibrin sealant/PRF® throughout the entire process.
  • Different spray modes can be selected depending on the actual procedure or area to be covered. Like the Processor Unit it has a large wheelbase and can easily be moved if required.
  • The disposable set comprises of two parts: A Preparation Kit used to prepare the fibrin sealant or PRF® solution before surgery, and an Application Kit used to activate and apply the fibrin sealant/PRF® solution.

 

  • Preparation Kit
    The Preparation Kit contains the specially designed Preparation Unit – a sterile disposable device in which the patient’s blood is collected, the biochemical process carried out, and the fibrin sealant or PRF® solution harvested.

 

  • The Application Kit
    The Application Kit contains the Spraypen®1 and all other items required to prepare the system for the delivery of the fibrin sealant or PRF® solution. The Spraypen® is a sterile, disposable, hand held device which delivers the fibrin sealant or PRF® solution to the tissue. The revolutionary and patented design offers the surgeon unparalleled freedom in controlling the application unlike any other product on the market today.

 

1Besides the Spraypen®, the Vivostat® system offers different types of applicators, e.g. the Endoscopic Applicator. For a full list of application devices click here

1-2-3 Spray

Three easy steps to prepare Vivostat® Fibrin Sealant or Vivostat PRF®

1. Draw blood from the Patient

Fibrin Prep With Blood Inside

At the time of surgery or up to 24 hours before1, citrate (supplied with the kit) is added to the Preparation Unit. 120 ml of the patient’s own blood is then drawn into the same unit.

2. Process the patient’s blood

Vivostat Processor 800

The Preparation Unit is placed in the Processor Unit. At the touch of a button the process starts; after approx. 25 minutes, an autologous fibrin or PRF® solution is ready for use. No thrombin or bovine components are added to the blood at any time.

3. Load the Applicator Unit and spray

Vivostat Display Applicator

The Fibrin or PRF® solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices (e.g. the Spraypen). 1This depends on the type of kit being used. Always consult the “Instructions for Use” supplied with the kit to determine the correct preparation.

The following video illustrates how to prepare and apply autologous fibrin sealant.

Presentation DVD from Vivostat A/S on Vimeo.