INSTRUCTIONS FOR USE

 

Easy to apply

 

1

Remove all residues of previous medication and wash the wound and the area around the wound (with running water or 0.9% Sodium Chloride Solution (Saline)). Thereafter, dry the wound well.

2

Shake the bottle well (by inversion over 10 times) prior to application.

3

When applying PolyHeal® Micro, the wound should be facing up. Open the bottle and drip-apply PolyHeal® Micro suspension slowly to the wound surface in order to moisten the wound bed and borders.

4

Wait ~20 seconds for absorption of material.

5

Use a new gauze pad as a primary dressing, preferably non-woven type, to cover the entire wound surface including edges.

6

Saturate the gauze pad with PolyHeal® Micro and apply it onto the wound area including the edges.

7

Bandage the wound using standard loose dressings that will keep the primary dressing in place. Do not use adhesive tapes. If pressure/elastic dressing is needed (as used in venous ulcers), it may be applied over the loose bandage.

INFORMATION FOR PHYSICIANS

Please, see below more information on how to use PolyHeal® Micro.

• In case of local infection, use appropriate antibacterial therapy before application of PolyHeal® Micro.
• Remove necrotic tissue before treatment with PolyHeal® Micro.
• Debridement or excision must be done thoroughly to remove any remaining necrotic tissue if it is possible.
• If removal of necrotic tissue is impossible, it is recommended to surgically incise the necrotic surface (scarification) in order to provide access and contact of PolyHeal® Micro with healthy wound bed beneath the necrotic eschar.
• Formation of red, healthy granulation tissue is a primary function of PolyHeal® Micro. The treatment should proceed as long as the wound improves (granulation tissue forms and wound size is reduced).

CONTRAINDICATIONS

PolyHeal® Micro should not be used:

• In patients with known sensitivity to the device’s compounds.
• In infected or heavily exudating wounds.
• In wounds suspected of malignancy.

PRECAUTIONS

Please, see below the precautions when using PolyHeal® Micro.

• PolyHeal® Micro is not for use in infected, profusely exudating and/or necrotic wounds.
• There is limited experience in the use of PolyHeal® Micro in deep-tunnelled wounds and wounds connected to body cavities (abdomen, mediastinum and cranial cavities).
• PolyHeal® Micro is for single use only. Reuse could lead to contamination of the wound and infection.
• Do not re-sterilize. PolyHeal® Micro is sterile if the bottle is unopened and undamaged.
• Discard all opened bottles of PolyHeal® Micro.
• Do not use after the expiry date.
• Keep out of reach and sight of children.
• Do not use PolyHeal® Micro in conjunction with ointments, creams, and oily products.
• In case the first few days of treatment with PolyHeal® Micro are accompanied by pain, itching, or skin burning sensation around the wound area, a systemic medication for pain relief can be used (do not apply local or topical medication) without interrupting the treatment with PolyHeal® Micro.
• In case of persistent or aggravated side effects, such as local infection, allergic reaction, excessive redness, pain, itching, skin burning sensation or swelling, the use of PolyHeal® Micro should be interrupted until the patient consults his/her physician.
• Treatment should be stopped if granulation tissue protrudes over the wound’s edges (over-granulation) and the wound may be topically treated to control the over-granulation.

FAQ's

Please, see below the most common questions about the application of PolyHeal® Micro.

+ 1. After applying PolyHeal® Micro, what should I expect and/or see?

Appearance-wise:

The surface itself may have different appearances according to its condition - clean, exudates, eschar, granulation tissue, etc. As healing progresses, more and more rich, red, granulation tissue, often bleeding with minimal touch, will appear. This tissue is the treatment's expected results. The bleeding is capillary bleeding, from the newly formed fragile new capillaries. With the progression of healing, the granulation tissue may start to change color as it becomes fibrotic, while growing epithelium may further change the color and texture.

Sensation-wise:

In most cases, the sensation is a normal, pain free, similar to routine wet dressing change. Wetting the dressing with water or saline may further ease its removal. In addition, the removed dressing may have some exudates absorbed to its inner surface. In some cases, itching may appear after several days of treatment, which is quite normal in wound healing. If the itching becomes painful and redness appears on the surrounding skin, with or without fever, the patient should consult their treating physician.

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+ 2. How will the wounds close following PolyHeal® Micro treatment?

The final goal is to heal and close the wound as soon as possible. Once the wound is covered mostly with healthy granulation tissue, a decision by the treating physician should be taken:

  • If the wound continues to decrease in size, or if the physician foresees that the wound may close spontaneously over an acceptable period of time, PolyHeal® Micro treatment may be continued until total wound closure.
  • The physician could also decide to graft the wound bed over the newly formed granulation tissue to expedite wound closure.
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+ 3. When should the physician discontinue the treatment with PolyHeal® Micro to achieve wound closure?

PolyHeal® Micro treatment should be continued as long as there is progress in the creation of a healthy granulating wound bed that enables continuous and complete wound closure or grafting. If the wound discontinues to progress for a medically substantial period of time, the wound may be grafted, when feasible, depending on the condition of the wound bed or alternatively, the physician may change to another treatment modality aimed to facilitate spontaneous wound closure.

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+ 4. Are NCM´s safe?

  • All regulatory required pre-clinical safety studies were successfully conducted demonstrating no toxic concern.
  • Overall, NCM´s have been shown to be safe and mostly mild. Unrelated Adverse Events (AEs) were reported in the clinical studies that were resolved by study completion. Only very few related AEs were reported.
  • Generally, AEs associated with NCM´s included redness, swelling, pain (may be relieved by oral analgesics), itching (in the few first days) and skin burning sensation (in the few first days).
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+ 5. Do the microspheres remain in the wound? If yes, can this be harmful?

  • Most of the microspheres do not remain in the wound as they are cleared during the dressing process. In vivo animal study results demonstrated that after 3 days following application, about 70% of the NCM’s were eliminated from the wound bed and about 96% were cleared from the wound bed by day 7. The estimated elimination T1/2 is 32 hours from application.
  • There were pre-clinical studies in mice using fluorescent beads that demonstrated that the size of the microspheres was too large to enter the blood or cells and the beads that remain are confined to the wound area. Some of the beads are encapsulated within newly formed tissue in a similar way as tattoo particles. The microspheres are made of medical grade, non-biodegradable polystyrene, are non-toxic and biocompatible and currently used in medical devices.
  • No gross pathological observations nor pathological histological signs were found during a long term, 28 days, animal safety study.
  • A long term follow up of patients from the RCT was concluded with no special safety concerns.
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+ 6. What is the preferred dressing to use with PolyHeal® Micro?

It is recommended to use a non-woven cotton Gauze pad or similar, that does not contain active absorptive material other than cotton.

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+ 7. Why use gauze to cover PolyHeal® after its application? Isn’t it too primitive?

Gauze was chosen during the clinical study to ensure:

  • There was no adverse interaction between PolyHeal® and the primary dressing.
  • That PolyHeal® is kept in contact with the wound and not absorbed by the primary dressing.
  • To allow for the second daily application, if needed, without disturbing the primary dressing (e.g. the gauze on the wound).

Please be careful while using impregnated dressings and high absorbent dressings as these may interfere with PolyHeal®’s activity.

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+ 8. What is the interaction with antibiotics? Silver?

No studies have been conducted to assess PolyHeal® Micro interactions with other agents.

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+ 9. Could we cover the gauze with a film?

In the Instructions for use it is recommended to use a conventional bandage to keep the primary dressing in place. If gauze is secured with a film dressing, it should be closely monitored, to diagnose any unsuitable event as soon as it starts. In Venous Ulcers, the compression bandage will be applied over the film dressing, if used.

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+ 10. Can you use PolyHeal® Micro with pressure bandages?

Yes. In Venous Ulcers, the compression bandage should be applied over the dressing.

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