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A prospective study in adult spinal cord injury (SCI) persons was conducted to determine the efficacy and safety of MPPT (micropore particle technology – Amicapsil) for the treatment of wounds below the site of injury. SCI-persons have an immune deficiency syndrome due to the disruption of communication between the nervous and the immune system, and they consequently have impaired immune responses resulting in reduced ability to fight infections, poor wound healing and increased risk of developing osteomyelitis.

There is no effective treatment for these wounds, and they represent a huge risk to SCI-persons as they often give rise to secondary complication such as osteomyelitis and sepsis and can have significant impact on quality of life, e.g. by forcing the person to maintain bed-rest for extended periods of time thus putting an end to an active life both professionally and socially. NICE (UK) directly advices against the use of antimicrobials for the treatment of pressure ulcers.

Study design

The study included 36 wounds in para- and tetraplegics recruited from the National Spinal Injuries Centre, Stoke Mandeville Hospital, Aylesbury, UK; The Duke of Cornwall Spinal Treatment Centre, Salisbury, UK; Defence Medical Rehabilitation Centre (DMRC), Stanford Hall, UK; NHS Wiltshire Community Care, UK; BackUp Trust, UK; and SIA (Spinal Injuries Association), UK.

Outcome

  • MPPT is effective in an immune deficient population, i.e. spinal cord injury.
  • Acute wounds, i.e. less than 2 months old: 100 % closure rate.
  • Chronic wounds, i.e. more than 6 months old:
    • Grade 3: MPPT lead to full closure. Time to closure depend on infecting agent, age of wound and prior treatment approaches
    • Grade 4 without osteomyelitis: All wounds progress towards closure, but time to reaching closure depends upon the extent of tissue infection, level of tissue abscesses, bladder and bowel accidents.
    • Grade 4 with underlying osteomyelitis: All wounds were freed of soft-tissue infection. The soft tissue regenerated  except for the creation of a stable non-infected exit tract for the osteomyelitic debris.
  • Effective treatment of wound infections including by the multi-resistant species P. aeruginosa, K. pneumoniae and S. marcescens.

A key finding was that, if treatment was initiated before the wound was 2 months old, MPPT achieved stable closure in all wounds. Also, compared to a chronic wound, the treatment of an acute wound is simple, patients can do it themselves after receiving brief written or verbal instructions, and fewer applications are required. The ability to self-care also provides considerable independence.

Guest et al. (2018), using NHS (UK) community data from the general population treated with standard-of-care, found that only 14% of infected pressure ulcers (grade 1-4) healed within the first 12 months of reporting the ulcer to their doctor, and, for those healed, the average time to closure was 7.7 months. The annual cost of treatment was approximately £11,000. Despite the recommendation of NICE, antimicrobials were widely used and, in the SCI-population, their use will mean that most will develop osteomyelitis. The findings also have huge cost implications as most acute wounds only required £85-£130 worth of MPPT to reach closure, whereas the annual cost of treating a pressure ulcer with standard-of-care is close to £11,000 and these costs would continue year-on-year and would often lead to the need for flap-surgery with further financial and medical implications.

 

Effects of Amicapsil (MPPT) treatment on the risks caused by wound. Risks can be septicaemia, development of osteomyelitis and further spread of infection. For grade 1-3 wounds, not having penetrated the adipose layer (tela subcutanea), data indicate that the risk does not increase beyond a certain level. For grade 4 wounds, risk increases as infection can spread unhindered in the tissue and this will at some point lead to the development of osteomyelitis. Once osteomyelitis is present, surgery is required to resolve the condition. Without osteomyelitis, MPPT can achieve wound closure, but time to reach wound closure increases with wound age. With osteomyelitis, MPPT can control soft tissue infection and the body will form exit tracts for debris from the infected bone. However, as MPPT cannot affect osteomyelitis inside the bone, the osteomyelitis will gradually worsen and at some point MPPT will no longer be able to control the amount of debris coming from the bone, including preventing spread to other structures.