Here you will find the most common questions about PolyHeal® Micro.
PolyHeal® Micro is a unique microsphere technology indicated for the treatment of ulcers of different etiologies and stagnant hard-to-heal wounds, including those with exposed bones and/or tendons without infection.
The application of PolyHeal® Micro leads the patient’s own cells to reactivate the healing process and accelerates the formation of granulation tissue, favouring wound closure.
Easy and rapid topical application in difficult access areas like interdigital or cavitated wounds. It can be applied by the own patient or a trained caregiver.
PolyHeal® Micro offers a cost-effective treatment option for chronic ulcers and hard-to-heal wounds, due to a reduction in treatment duration, in the wound care expenditure and hospitalization burdens.
NCM refers to the polystyrene microspheres that carry sulfonate groups on their surface, providing a net negative charge. Such charges increase the readiness by which the macromolecules may anchor onto their surface.
PolyHeal® Micro is indicated for the treatment of ulcers of different aetiologies and stagnant and hard-to-heal wounds, including those with exposed bones and tendons without infection.
A hard-to-heal wound is a lesion that, despite having been treated with standard of care and beside other therapies, remains unhealed.
In a chronic wound there is a persistent activation of the inflammatory phase which does not progress properly, leading to stagnation.
This may be due to different comorbidities, infection, the presence of eschars, tissue hypoxia, etc.
PolyHeal® Micro should be stored at a temperature between 2°C and 30°C.
All the preclinical safety studies required by current regulations were carried out satisfactorily and did not demonstrate toxicity problems.
During clinical studies, adverse events (AE) not related with the product were reported, which were solved by the end of the study. Usually, the AEs associated with MCN were redness, swelling, pain (which can be treated with oral analgesics), pruritus (during first days) and burning sensation (during first days).
The follow-up of the randomised clinical trial concluded no particular safety findings.
Results obtained by in vivo and ex vivo techniques confirm that there is no systemic absorption of NCM, both at single dose and at repeated doses over time.
The ex vivo studies demonstrated that most of NCM (80%) were retained in the dressing, probably due to absorption by the non-woven gauze.
During the long-term safety study carried out in animals during 28 days, no pathological or histological signs were observed.
During the toxicity studies, no toxic or genotoxic findings were observed.
Polyheal® Micro is classified as class IIB.
Initially, the wound bed may present different appearances: clean, exudative, granulation tissue, etc. As long as healing evolves, granulation tissue keeps forming and may bleed easily. This tissue is one of the outcomes expected from the treatment with PolyHeal Micro. The bleeding comes from newly formed capillaries.
As healing progresses, the granulation tissue may change its color as it becomes more fibrotic, while the growing epithelium prevails and end up covering the whole wound area until complete closure is achieved.
In most cases, the experienced sensation during the dressing change is regular, non-painful and similar to a moistening dressing change. Wetting the dressing with saline solution or water, prior to the removal may ease this process. In addition, the dressing could have absorbed exudate on its inner surface. In some cases, pruritus may appear after a few days of treatment, which is normal during wound healing.
If pruritus turns into pain and redness of surrounding skin is observed, with or without fever, the patient should seek for medical advice.
PolyHeal® Micro reactivates the healing process and accelerates the production of granulation tissue, favouring wound closure. Two outcomes may be expected, depending on patient profile and wound characteristics:
In this case the physician may choose to continue with the treatment until the wound is closed by secondary intention or skin graft.
In this regard, it should be considered that we are facing complicated cases and that the chances of achieving complete closure by epithelialization are much lower. Therefore, the treatment with PolyHeal® Micro must be continued as long as the wound progresses in terms of production of granulation tissue or wound size reduces. We must consider at this point, to achieve wound closure by skin graft technique.
The use of non-woven gauze is recommended as primary dressing.
During the clinical trial the decision to use a non-woven gauze was to ensure:
Be careful when using saturated and highly absorbent dressings, as they may interfere with the activity of PolyHeal® Micro.
Studies have not been carried out to evaluate interactions between PolyHeal® Micro and other agents.
The instructions for use recommend a conventional bandage to keep the primary dressing in place. In case of fixing the gauze using a film, it must be strictly supervised, in order to notice any adverse event as soon as it appears.
Yes. In venous ulcers, the compressive bandage will be placed over the conventional bandage.