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Time for a change in hard-to-heal wounds

Xelma is a novel treatment for hard-to-heal wounds, primarily venous leg ulcers. Xelma provides a temporary extracellular matrix protein for cell attachment. This biological treatment approach is novel because it is designed to restore the balance by replacing crucial components of the defective extracellular matrix. In clinical investigations Xelma has shown promising benefits in hard-to-heal wounds.

The product

Xelma is a sterile ready-to-use product for topical application. Xelma consists of 1 ml viscous solution of extracellular matrix proteins (amelogenins) in propylene glycol alginate and water.

• Initiates wound healing in hard-to-heal wounds
• Functions as a temporary matrix for cell attachment
• Easy to handle

Areas of use

Xelma is indicated for hard-to-heal ulcers, primarily venous leg ulcers. Xelma can be used under compression therapy.

Application

Xelma is intended for topical application and should be covered by a secondary dressing such as Mepitel®, Mepilex® or Mepilex® Border and applied to the wound surface once weekly. If no improvement is observed within 6 weeks the treatment is to be reassessed.

How Xelma works

When applied to the wound bed Xelma provides a temporary extracellular matrix protein for cell attachment. This creates favourable conditions for wound healing by restoring vital cell functions including proliferation, migration, and production of growth factors and essential extracellular matrix components. Restoration of the cellular and biochemical balance is facilitated in the hard-to-heal wound, which will promote wound healing.

Assortment

Wound healing involves close interaction between several different cell types, extracellular matrix (ECM) components and growth factors. In hard-to-heal wounds the healing processes are disrupted by cellular and biochemical imbalances that compromise the repair processes 1,2.

During wound healing cell adhesion to the ECM (Fig. 1) is crucial for many cellular functions such as proliferation, migration and secretion of growth factors3,4,5. In many hard-to-heal wounds the ECM composition and remodeling is defective (Fig. 2) resulting in delayed wound healing6.

Fig. 1

Cells attached to the ECM during normal wound healing

Fig. 2

Damaged extracellular matrix components in hard-to-heal wound

New biotechnology for hard-to-heal wounds

The novel therapeutic approach to restore the damaged ECM proteins offers a great opportunity for hard-to-heal wounds. For example, the ECM adhesion protein fibronectin is often deficient in hard-to-heal wounds due to excessive degradation7,8. By replacing damaged ECM proteins, it is possible to restore the cellular balance and enhance healing processes.

References:

1. Falanga V (2000). Classification for wound bed preparation and stimulation of chronic wounds. Wound Repair Regen 8: 347-52.
2. Schultz GS, Sibbald RG, Falanga V et al (2003). Wound bed preparation: a systematic approach to wound management. Wound Repair Regen 11 (Suppl. 1): S1-S28.
3. Hynes RO (2002). Integrins: bidirectional, allosteric signalingmachines Cell 110: 673-87.
4. Schwatz MA, Ginsberg MH (2002). Networks and crosstalk: integrin signalling spreads. Nat Cell Biol 4: E65-8.
5. Eliceiri BP. Cheresh DA (2001). Adhesion events in angiogenesis. Curr Opion Cell Biol 13: 563-8.
6. Cook H, Davies KJ, Harding KG, Thomas DW (2000). Defective extracellular matrix reorganization by chronic wound fibroblasts is associated with alterations in TIMP-1, TIMP-2, and MMP-2 activity. J Invest Dermatol 115:225-33.
7. Data on file.
8. Mirastschijski U, Konrad D, Lundberg E et al (2004). Effects of a topical enamel matrix derivative on skin wound healing. Wound Repair Regen 12: 100-8.

What is Xelma extracellular matrix protein?

Xelma consists of amelogenin proteins, a thickening agent propylene glycol alginate (PGA) and water. Xelma has been proven to improve healing in hard to heal ulcers.

What is Xelma for?

Xelma is a medical device for treatment of hard-to-heal ulcers, primarily venous leg ulcers. It is indicated for use with standard compression therapy of non-infected wounds.

How is Xelma different from other therapies?

Xelma is the first product containing extracellular matrix protein, amelogenin, which temporarily replaces the damaged extracellular matrix proteins in the hard-to-heal wounds in order to restore wound healing.

How does Xelma work?

When applied to the wound bed Xelma provides a temporary extracellular matrix protein for cell attachment. This creates favourable conditions for wound healing by restoring vital cell functions including proliferation, migration and production of growth factors and essential extracellular matrix proteins. Restoration of the cellular and biochemical balance is facilitated in the hard-to-heal wound, which will promote granulation tissue formation and normal wound healing.

When should Xelma not be used?

Xelma should not be used on clinically infected wounds and in patients with known sensitivity to the product components.

How should I apply Xelma to the wound?

Apply a thin layer of Xelma matrix protein to the wound. The scale on the syringe will help to measure the amount.

How often should Xelma be applied?

Once a week

Does Xelma work under compression bandaging?

Yes, our clinical studies show that Xelma functions well under compression bandaging.

Who can apply Xelma?

All health care professionals

When should I start the treatment?

Xelma is the first choice of treatment for hard-to-heal venous leg ulcers when the standard treatment, moist wound healing and compression therapy, has failed.

What preparation of the wound bed is required before the first application of Xelma?

Cleanse the wound according to the normal cleansing procedures. NB. Sharp debridement, if indicated, should only be performed prior to the first application of Xelma.

What is extracellular matrix (ECM)?

The extracellular matrix defines the environment of cells. The ECM consists of several different macromolecules like proteins and polysaccharides. It provides mechanical strength and protection and functions as a medium for cell communication such as growth factor signalling. Most importantly the ECM provides vital cell-matrix adhesion, which regulates cell functions that are vital for wound healing.

Where do I store Xelma?

Xelma must be stored in refrigerator.

How long will it take before I notice improvement?

Healing times are different depending on the patient and the wound, like wound age and size. If no improvement can be observed the treatment should be reassessed after 6 weeks. 

Clinical Results

•  The Effect of Xelma on Hard-to-heal Venous Leg Ulcers Randomised Single-blind Study 
   
• Amelogenin Proteins (Xelma) in Venous Leg Ulcers, Controlled Pilot Study

Case studies

• Case studies from a Pan European Randomised Controlled Trial 

Articles & proceedings 

• Xelma product sheet 
   
• Predicting Hard-To-Heal Wounds, A New Management Tool  

Product info 

• Xelma product sheet  
  

	1. Measure the wound area prior to application and cleanse the wound according to the normal cleansing procedures. Remove the rubber cap of the syringe. NB. Sharp debridement, if indicated, should only be performed prior to the first application of Xelma.
	2. Attach the silicone applicator for easy application of Xelma. Ensure that the product is not cold when applied on the wound.
	3. Carefully apply a thin layer of Xelma over the wound area. The syringe is equipped with a scale related to wound size for guidance.
	4. Cover wound with secondary dressing, e.g. Mepitel, Mepilex or Mepilex Border. Depending on exudate level, the secondary dressing can be changed in between applications. Apply compression therapy when appropriate.

• Xelma should not be applied to infected wounds or until excessive exudate is controlled.
• Necrotic tissue, fibrin or slough should be removed before initiating the treatment. 
• The syringe and applicators are single use items. Do not re-sterilise or reuse syringe or applicators. 
• Do not use if sterile package is opened or damaged.
• Do no use after the expiration date