CLINICAL EVIDENCE

Please see below the more relevant clinical information on NCM Technology
Wound ‘dechronification’ with negatively-charged polystyrene microspheres: a double-blind RCT1.
Shoham Y, et al.

Statistically significant results - 2.5 times higher - in ‘Wound area reduction’ in the NCM treated patients.

Statistically significant results - 6 times higher vs. control - in ‘Improving formation of healthy granulation tissue’ in the NCM treated patients.

Statistical significant results of 27.3% in ‘Reducing in the wound area’ in the VLU’s NCM treated patients vs. a 10% increase in control.

+ More info

Long term outcomes of a randomized controlled trial (RCT) with Negatively Charged Microspheres (NCM) technology compared to control2.
Kaufman H, et al.

Long-term safety and efficacy results as well as a potential reduction in wound care and hospitalization burdens.

+ More info

PATIENTS TREATED WITH NCM’S GOT A 6 TIMES HIGHER PROBABILITY
OF MEETING THE PRIMARY ENDPOINT OF ≥ 75% OF LIGHT-RED
GRANULATION - LRG - TISSUE
AT 4 WEEKS OF TREATMENT
(OR = 5.95; P<0.01)

Number of patients to achive ≥ 75% Light-Red Granulation
tissue coverage, according to treatment group
 

Almost 2 TIMES FASTER (27 VS. 49 DAYS)
reaching the primary endpoint of ≥ 75% of light-red
granulation - LRG - Tissue coverage

 

Among the post-trauma/postoperative sub-population, after 4 weeks of treatment, 59% (n=10/17) of patients treated with NCM´s achieved ≥ 75% LRG Tissue vs. 25% (n=3/12) of control patients

 

PATIENTS TREATED WITH NCM’S GOT A 2.5 TIMES HIGHER STATISTICAL WOUND AREA REDUCTION VS. CONTROL, AT 4 WEEKS

Relative change in wound surface area (%),
by treatment group
 

27.3% (P=0.01) ‘WOUND AREA REDUCTION’ IN THE VLU PATIENTS TREATED WITH NCM’S VS. A 10% INCREASE IN THE CONTROL GROUP

Number of patients to achieve ≥ 75% light-red
granulation tissue coverage in the venous
insufficiency subgroup
Relative change in wound size from week o to
week 4 in the venous insufficiency subgroup
 

FOR PATIENTS WITH EXPOSED BONES OR TENDONS (N=10; SEVEN IN NCM
GROUP AND THREE IN CONTROL GROUP), ≥ 75% OF WOUND COVERAGE
WITH LIGHT-RED GRANULATION TISSUE WAS ACHIEVED IN 4 PATIENTS
(57%) TREATED BY NCM AND BY NONE OF THE CONTROL PATIENTS

50% more wounds that remained closed in the NCM's group

Less than half - 14.8% vs. 30% respectively - of the incidence of adverse events on the NCM's Group vs. control
New method for treating hard-to-heal wounds: clinical experience with charged polystyrene microspheres3.
Govrin J, et al.

NCM’s effectively stimulate the wound healing process in recalcitrant lesions.

NCM’s serve for wound healing in chronic and acute wounds, regardless of their etiologies.

+ More info

Post-facelift flap necrosis treatment using charged polystyrene microspheres4.
Weissman O, et al.

Wounds demonstrated both accelerated granulation tissue formation and rapid reepithelialization rates after 10 and 11 days of treatment.

No complications or side effects were encountered.

Application of PolyHeal® Micro is simple, safe and painless.

MORE THAN 75% GRANULATION TISSUE COVERAGE WAS ACHIEVED
IN 65% OF THE PATIENTS TREATED WITH NCM

Percentage achieving >75% granulation
 
 

More than 75% granulation tissue coverage was achieved in 68% of the patients (15 of 22) with Exposed Bones and Tendons, over 5 weeks

 

95–100% REDUCTION IN SIZE IN ABOUT HALF OF THE WOUNDS
AFTER AN AVERAGE OF 4.5 WEEKS OF ACTIVE TREATMENT

Percentage achieving >95% wound reduction
 
Percentage achieving complete wound closure
 
 

Complete wound closure was achieved in 21 of 54 wounds (39%) and on 10 of 22 (45%) of those with Exposed Bones and Tendons - EB&T - patients

Treatment of wounds following breast reduction and mastopexy with subsequent wound dehiscence with Charged Polystyrene Microspheres5.
Weissman O, et al.

Most wounds showed both accelerated granulation tissue formation as well as swift epithelization rates after 17 to 30 days of treatment.

No complications / side effects were encountered.

Patients did not report pain in the wound area during dressing changes.

CLINICAL EVIDENCE

Please see below the more relevant clinical information on NCM Technology
Wound ‘dechronification’ with negatively-charged polystyrene microspheres: a double-blind RCT1.
Shoham Y, et al.

Statistically significant results - 2.5 times higher - in ‘Wound area reduction’ in the NCM treated patients.

Statistically significant results - 6 times higher vs. control - in ‘Improving formation of healthy granulation tissue’ in the NCM treated patients.

Statistical significant results of 27.3% in ‘Reducing in the wound area’ in the VLU’s NCM treated patients vs. a 10% increase in control.

+ More info

PATIENTS TREATED WITH NCM’S GOT A 6 TIMES HIGHER PROBABILITY
OF MEETING THE PRIMARY ENDPOINT OF ≥ 75% OF LIGHT-RED
GRANULATION - LRG - TISSUE
AT 4 WEEKS OF TREATMENT
(OR = 5.95; P<0.01)

Number of patients to achive ≥ 75% Light-Red Granulation
tissue coverage, according to treatment group
 

Almost 2 TIMES FASTER (27 VS. 49 DAYS)
reaching the primary endpoint of ≥ 75% of light-red
granulation - LRG - Tissue coverage

 

Among the post-trauma/postoperative sub-population, after 4 weeks of treatment, 59% (n=10/17) of patients treated with NCM´s achieved ≥ 75% LRG Tissue vs. 25% (n=3/12) of control patients

 

PATIENTS TREATED WITH NCM’S GOT A 2.5 TIMES HIGHER STATISTICAL WOUND AREA REDUCTION VS. CONTROL, AT 4 WEEKS

Relative change in wound surface area (%),
by treatment group
 

27.3% (P=0.01) ‘WOUND AREA REDUCTION’ IN THE VLU PATIENTS TREATED WITH NCM’S VS. A 10% INCREASE IN THE CONTROL GROUP

Number of patients to achieve ≥ 75% light-red
granulation tissue coverage in the venous
insufficiency subgroup
Relative change in wound size from week o to
week 4 in the venous insufficiency subgroup
 

FOR PATIENTS WITH EXPOSED BONES OR TENDONS (N=10; SEVEN IN NCM
GROUP AND THREE IN CONTROL GROUP), ≥ 75% OF WOUND COVERAGE
WITH LIGHT-RED GRANULATION TISSUE WAS ACHIEVED IN 4 PATIENTS
(57%) TREATED BY NCM AND BY NONE OF THE CONTROL PATIENTS

Long term outcomes of a randomized controlled trial (RCT) with Negatively Charged Microspheres (NCM) technology compared to control2.
Kaufman H, et al.

Long-term safety and efficacy results as well as a potential reduction in wound care and hospitalization burdens.

+ More info

50% more wounds that remained closed in the NCM's group

Less than half - 14.8% vs. 30% respectively - of the incidence of adverse events on the NCM's Group vs. control
New method for treating hard-to-heal wounds: clinical experience with charged polystyrene microspheres3.
Govrin J, et al.

NCM’s effectively stimulate the wound healing process in recalcitrant lesions.

NCM’s serve for wound healing in chronic and acute wounds, regardless of their etiologies.

+ More info

MORE THAN 75% GRANULATION TISSUE COVERAGE WAS ACHIEVED
IN 65% OF THE PATIENTS TREATED WITH NCM

Percentage achieving >75% granulation
 
 

More than 75% granulation tissue coverage was achieved in 68% of the patients (15 of 22) with Exposed Bones and Tendons, over 5 weeks

 

95–100% REDUCTION IN SIZE IN ABOUT HALF OF THE WOUNDS
AFTER AN AVERAGE OF 4.5 WEEKS OF ACTIVE TREATMENT

Percentage achieving >95% wound reduction
 
Percentage achieving complete wound closure
 
 

Complete wound closure was achieved in 21 of 54 wounds (39%) and on 10 of 22 (45%) of those with Exposed Bones and Tendons - EB&T - patients

Post-facelift flap necrosis treatment using charged polystyrene microspheres4.
Weissman O, et al.

Wounds demonstrated both accelerated granulation tissue formation and rapid reepithelialization rates after 10 and 11 days of treatment.

No complications or side effects were encountered.

Application of PolyHeal® Micro is simple, safe and painless.

Treatment of wounds following breast reduction and mastopexy with subsequent wound dehiscence with Charged Polystyrene Microspheres5.
Weissman O, et al.

Most wounds showed both accelerated granulation tissue formation as well as swift epithelization rates after 17 to 30 days of treatment.

No complications / side effects were encountered.

Patients did not report pain in the wound area during dressing changes.

FAQ's

Please see below the most common questions about clinical evidence on NCM Technology.

+ 1. In the RCT, why was Polyheal® compared only to Saline dressing?

There is no single, accepted treatment defined as Standard of Care for different wound types, since many treatments answer different needs in different wound etiologies. Saline soaking provides the two most important healing factors: moisture and daily cleansing, thus reducing bacterial and exudates load by dressing change (wet-to-dry) and is used extensively, both in real day life as well as in clinical evaluations. As both PolyHeal® and Saline are clear solutions, using Saline as control enabled to blind the study in accordance with ICH guidelines. These are the reasons that saline dressing is an accepted SOC treatment in comparative, controlled studies.

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+ 2. In the RCT, why only 1 month active end point and not until closure?

The primary role of PolyHeal® is to change the status of the wound from stagnant to actively healing. This endpoint has been achieved and measured within 4 weeks of use. Wound closure depends on many additional factors such as the wound size, movement, use of skin grafting or the choice of closure by secondary intention.

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+ 3. Were the Saline and Polyheal® groups comparable?

The groups were balanced on most patients ’and wounds’ baseline characteristics, except for wound size and wound duration - wound size was larger in the saline group, whereas wound age was longer in the PolyHeal® group. A post-study regression analysis was performed and confirmed the study results.

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+ 4. In the RCT, what happened after the 4 week active phase?

The gaps that had developed between the two treatments arms were maintained during the 8 week follow up period and produced a 2-fold difference in wound closure rate trend.

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+ 5. Why did we include multiple wound types in all PolyHeal® studies?

A mixture of wound etiologies reflects the real world variety of hard to heal chronic wounds and demonstrate PolyHeal® efficacy and safety in many different hard to heal wound etiologies.

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

2. 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. Copenhagen May 15th-17th, 2013.
Link to publication

3. Govrin J, et al. New method for treating hard-to-heal wounds: clinical experience with charged polystyrene microspheres. Wounds UK. 2010; 6(4); 52-61.
Link to publication

4. Weissman O, et al. Post-facelift flap necrosis treatment using charged polystyrene microspheres. Can J Plast Surg. 2013;21(1):45-7.
Link to publication

5. Weissman O, et al. Treatment of wounds following breast reduction and mastopexy with subsequent wound dehiscence with charged polystyrene microspheres. Wounds. 2014; 26(2):37-42.
Link to publication