Clinical Evidence & Studies

CLINICAL EVIDENCE

Publications and Clinical Studies
with PolyHeal® Micro

CLINICAL EVIDENCE

Publications and Clinical Studies
with PolyHeal® Micro

Outstanding Publications

The most relevant clinical information about Negatively-Charged Microspheres (NCM) is provided below.

Shoham Y, et al. Wound ‘dechronification’ with negatively-charged polystyrene microspheres: a double-blind RCT. J Wound Care. 2013 Mar; 22(3):144-55.

Double-blind, randomized clinical trial (RCT). Patients with hard-to-heal wounds, defined as refractory to treatment for at least 4 weeks, or those with wounds with exposure to bone, tendon, or ligaments, were eligible for inclusion and randomly assigned to the MCN or control group. Both groups were treated (MCN or control) for 4 weeks. Fifty-eight patients completed the study. The primary endpoint was defined as coverage of > 75% of the wound area by light red granulation tissue after 4 weeks of treatment.

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Kaufman H, et al. Long term outcomes of a randomized controlled trial (RCT) with Negatively Charged Microspheres (NCM) technology compared to control (Poster 374). Presented in European Wound Management Association Congress (EWMA) 2013.

After the randomized clinical trial, patients were supervised twice a week for an additional 8 weeks. During this time they were treated with standard therapy, at the discretion of the investigators, and were re-evaluated 2 years after inclusion in the trial.

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Hard to heal diabetic foot ulcers
Lázaro – Martínez J.L, et al. Hard to heal diabetic foot ulcers treated using negatively charged polystyrene microspheres: a prospective case series. Journal of Wound Care. Vol 28. No 2. Feb 2019.

Prospective case series of patients with difficult-to-heal diabetic foot ulcers. Daily treatment with MCN was applied for four weeks, although the healthcare professional could decide to continue treatment with MCN in some patients. Cases were followed up to week 12. MCN treatment was completed in 17 ulcers (16 patients). The following parameters were measured: Wollina (granulation tissue, colour and tissue consistency), area and reduction (%) of wound area and complete closure.

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List of publications and studies

Title

Authors

Date

Overcoming the Inflammatory Stage of Non-Healing Wounds: In Vitro Mechanism of Action of Negatively Charged Microspheres (NCMs). Nanomaterials 2020, 10, 1108.
G. Gainza et. al.
2020
Hard to heal diabetic foot ulcers treated using negatively charged polystyrene microspheres: a prospective case series. Journal of Wound Care. Vol 28. No 2. Feb 2019.
Lázaro - Martínez J.L,et al.
2019
Experience in the Management of Patients with Chronic Vascular Ulcers of the Lower Limbs Using Negatively Charged Polystyrene Microspheres
María Teresa Cacua Sánchez
2019
Negatively charged polystyrene microspheres technology experience about non-responding diabetic foot ulcers. Presented in the International Symposium on the Diabetic Foot (ISDF) 2019
JP Sánchez Ríos et al.
2019
Hard to heal wounds: Results of a treatment based on Negatively Charged Polystyrene Microspheres (NCM). Presented in EWMA 2018. Krakow May 9th-11th 2018.
De Alcalá D, et al.
2019
Clinical effects of negatively charged polystyrene microspheres (NCM) treatment in hard to heal wounds. Presented in EWMA 2018. Krakow May 9th-11th 2018.
De La Cuesta Díaz.
2018
Treatment of wounds following breast reduction and mastopexy with subsequent wound dehiscence with charged polystyrene microspheres. Wounds. 2014; 26(2):37- 42.
Weissman O, et al.
2014
Post-facelift flap necrosis treatment using charged polystyrene microspheres. Can J Plast Surg. 2013;21(1):45 7.
Weissman O, et al.
2013
Long term outcomes of a randomized controlled trial (RCT) with Negatively Charged Microspheres (NCM) technology compared to control. Presented in European Wound Management Association Congress (EWMA) 2013. Copenhagen May 15th-17th, 2013.Copenhagen May 15th-17th, 2013.
Kaufman H, et al.
2013
Wound ‘dechronification’ with negatively-charged polystyrene microspheres: a double-blind Randomized clinical trial. Journal of Wound Care 2013 Mar; 22(3):144-55.
Shoham Y, et al.
2013
New method for treating hard-to-heal wounds: clinical experience with charged polystyrene. Wounds UK. 2010; 6(4); 52-61.
Govrin J, et al.
2010