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  1. CLINICAL COMPARISON OF ACTICOAT™ & OTHER SILVER COMPOUNDS IN BURNS

  1. Antimicrobial Effects and Infection Control

A number of clinical trials have been performed comparing antibacterial efficacy of the nanocrystal silver delivery system.

Tredget et.al performed a randomized prospective trial in burns comparing nanocrystal silver delivery versus silver nitrate 0.5%.  The nanocrystal silver significantly decreased wound colonization.  In addition, there was a significant decrease in burn wound infection (> 105 organisms per gram tissue) and bacteremias.

Stephens et al compared nanocrystal silver delivery and silver sulphadiazine on deep burns in 20 patients.  There was no evidence of infections in either group but nanocrystalline silver (Acticoat) was reported to produce less pain, and nursing time due to less frequent dressing changes, i.e. twice a day versus every three days.

In a study reported by Honori et.al., randomized prospective trial, nanocrystal delivery use resulted in a 0% infection rate compared to 5.2% with the use of silver sulfadiazine on donor sites in burn patients.  Another study on superficial partial thickness burns reported a 50% decrease in local infections with the use of nanocrystal silver versus xeroform gauze, a common treatment for superficial burns.  A study in toxic epidermal necrolysis patients reported nanocrystal silver to be as effective as silver nitrate in controlling infection.  There was much less pain and less nursing time required with the silver membrane.(34) 

In summary to date, clinical studies on burns have demonstrated that use of the nanocrystal silver delivery system is either better or at least as effective an antimicrobial as the currently used silver compounds.  However, every study demonstrated less patient pain and considerably less nursing time with use of the silver membrane.

  1. Improved Healing

Several clinical trials have identified that nanocrystal silver delivery improves healing of partial thickness wounds.  These wounds include donor sites, partial thickness skin slough disorders and re-epithelialization of meshed skin grafts.

 

Efficacy Studies on Nanocrystal Silver Use (Increased Re-epithelialization Rate)

Donor Sites Acticoat vs. Xeroform

- Increased healing with nanocrystal silver Acticoat vs. SSD+

- Improved healing with nanocrystal silver  

Skin Slough Acticoat vs. Silver Nitrate (TENS)

          - Improved healing

Meshed Grafts Acticoat vs. Neosporin Solution

        -30% reduction with Acticoat in time to re-epithelialization

+ silver sulfadiazine

* nanocrystal silver               

 

The donor site studies comparing nanocrystal silver versus xeroform also compared, a moist healing used with the silver dressing with a dry environment seen with xeroform making it difficult to determine what component of the silver or the moisture was responsible.  The study, by Demling, et.al., on mesh graft re-epithelialization compared the silver moist healing environment with that of a standard diluted Neosporin solution.  In this study, the only difference in the wound environment was the presence of the nanocrystalline release of silver.  The study was performed on the rate of re-epithelialization across a standard meshed graft on an excised wound, both approaches being used on the same patient.  The significant increase in healing with pure silver more clearly reflects silver healing properties. The mechanisms are yet to be defined.

 

  1. Versatility

Because of the potent antimicrobial pro-healing properties and ease of use, the nanocrystal silver delivery system has been effectively used on a variety of burns with success.  Currently ActicoatTM has been reported to be effective and efficient in managing the wounds described below.

 

Uses of nanocrystalline silver delivery in burns:
  • Deep dermal to full thickness: prior to and after excision
  • Partial thickness burns

- usually large with a potential for infection

  • Large skin sloughs (TENS)

  • Donor sites
  • Meshed skin grafts

 

The ability to use one effective silver product from admission of a deep burn to coverage of meshed grafts and donor sites has many clinical uses and cost effective advantages.

The data on antimicrobial efficacy in deep burns has been described.  The data on donor sites indicates decreased infections as well as decreased pain with Acticoat, especially compared to xeroform gauze.  The data on use over meshed skin grafts indicates a prohealing as well as antimicrobial effect.

One wound which deserves special attention is the partial thickness skin slough wound as seen, e.g. in Toxic Epidermal Necrolysis (TENS).  Typically, the wounds are partial thickness but very large in size and extremely painful.  In addition, these wounds are often present in immuno-compromised patients and therefore require antimicrobial coverage.

The major problems in these patients are control of severe pain, infection and healing.  The standard use of antimicrobials with frequent dressing changes typically leads to not only severe pain and high narcotic needs but wound manipulation induced endotoxemia, bacteremia, increased inflammation and immense nursing resources. 

Less pain, fewer wound related side effects, and negative effects of narcotics have been well documented with nanocrystal silver use. Increased rate of re-epithelialization has also been reported likely due to the ability to maintain an undisturbed optimum healing environment.

 

Use of ActicoatTM to cover meshed skin graft

 

Acticoat in place day 3

Note excellent conformability

 

TENS Patient

Wound Coverage with ActicoatÔ

 

ActicoatTM changed every 3-5 days.

 

 

  1. Patient Comfort and Decreased Toxicity

The major cause of pain in the burn patient is the dressing change.  This problem is of less concern with deep burns.  However, wound manipulation does lead to increased bacteremias, cytokine release and an inevitable pyrogen response in the post-dressing change period.  The increased body temperature also corresponds with lethargy, hemo-dynamic instability and increased oxygen demands.  Increased CO2 production also occurs.

A number of studies have demonstrated less pain with dressing changes compared to the use of other products.  Honari et.al., compared the pain of a donor site treated with nanocrystal silver dressing versus SSD and noted a significant decrease in pain using the silver dressing.  Stephens et.al., reported a significant decrease in pain in deep burns using the silver delivery system compared to silver sulfadiazine SSD.  Tredget et al, reported a similar decrease in pain with dressing changes in burn wounds with nanocrystal silver delivery versus silver nitrate solution.   A decrease in pain has been reported in TENS patients using the silver delivery membrane compared to silver nitrate solution.

It is quite evident that wetting the outer surface of the silver dressing is much less painful than removal and replacement of SSD or use of silver nitrate in burns or xeroform in donor sites.

Decreasing the toxicity of wound manipulation is another significant benefit of the nanocrystalline silver delivery system, where wound manipulation is minimal.  Demling et.al., recently reported a study comparing the burn care response of nanocrystalline silver versus SSD in deep burns.  A randomized prospective study was undertaking looking at pain, cost effectiveness and wound care side effects of silver delivery compared to SSD.

 

Clinical Response to Dressing Changes+

 

Burn Size

Dressing Changes

Increased Temp.

(>101 F°)

Hemodynamic Changes

       

BP      

Pulse

SSD (n=25) 25±8% 42±10 100% 20% 100%
           
Silver Delivery 28±9% 36±9 10%* 5%* 40%*
*significantly different from silver delivery

+ time period from onset to 3 hrs post dressing

A significant decrease in wound care related complications were noted using the nanocrystalline silver.

 

  1. Cost Effectiveness

Several clinical studies on burns and skin sloughs have demonstrated a significant decrease in cost using the nanocrystal silver delivery system.  Demling, et.al.(67) recently reported a significant decrease in actual cost (not charges) for deep burn wound care due mainly to the marked decrease in nursing care and pain medication required.

Other studies have reported a similar cost effectiveness due mainly to at least a 60% decrease in nursing time for wound care.  The decrease in wound manipulation also markedly decreases pain, pain medications and narcotic induced morbidity. The studies include the management of skin slough disorders, deep burns. All studies demonstrated cost effectiveness with a cost saving of 15-25% compared to standard of care.

 

CASE 1:

Patient is a 40year old male injured in a plane crash.  He suffered deep burns to 60% of TBS plus a fractured pelvis.  He weighed 350 pounds and any turning was very difficult for him and the staff.  After initial resuscitation, all burns were covered with ACTICOATÔ until excision and grafting could be performed.

Initial assessment of back and buttock burns was that of a deep dermal burn which may require grafting.  Back and buttock care was markedly simplified by the use of ACTICOATÔ and buried catheters to rewet.  The wound beneath the ACTICOATÔ was clean and moist with minimal exudates.  Of interest was the fact that the back did not require excision but healed in 21 days.  Bacterial count was always scant growth.

 

Burn Admission                                    Burn Day 3

Note: burn is deep dermal to full thickness. Note: adherence presence of moisture layer and lack of exudates.
 
Burn Day 21

Burn completely re-epithelialized with return of pigment

 

 

CASE 2:

Patient is a 40-year old male injured in a plane crash.  He suffered deep burns to 60% of TBS plus a fractured pelvis.  He weighed 350 pounds and any turning was very difficult for him and the staff.  After initial resuscitation, all burns were covered with ACTICOATTM until excision and grafting could be performed.

 

Admission burn                           

 

Burns at day 10
Note: nice adherence of the ActicoatTM to the burn wound.

 

Burn at 14 days
Note: re-epithelialization

 

Summary

Nanocrystalline silver delivery by ActicoatTM is beneficial for the management of:

  • Partial and Full Thickness burn

  • Donor sites

  • Excised and grafted wounds

The mechanism is likely multifactorial:

  • Eliminating toxic complexes

  • Decreasing bacteria and inflammation

  • Moist wound healing

  • Decreased mechanical trauma

  • Direct healing effect of nanocrystal silver

TOC [Use of  ActicoatTM]

 

 

 


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