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Spinal cord injury and wound healing

The immune response to a wound consists of a local response activated by local factors, e.g. infective organisms or tissue damage; and a system-response controlled by the nervous system. The nervous system receives information about a wound via local sensory fibres and it activates the immune cells in that area via the sympathetic nervous system. In SCI, the ability to receive sensory information and to activate immune responses via the sympathetic nervous system to a specific location has been affected and this lack of coordinated input and output consequently prevents the body from optimising the immune response and controlling the healing processes. Data indicate that this causes a 50% reduction in the number immune cells recruited to a site of injury.

With the loss of neuronal control of the immune system, local systems become proportionately more important, i.e. the microbiome, the “skin immune system”, anatomical structures in the skin, and the adipose tissue directly underlying the dermis. However, once muscles are reached, specialised structures are lacking, making it easier for an infection to spread unhindered within the body.

Amicapsil-SCI (MPPT) is able to boost the strength of the immune cells, also in SCI, such that the body becomes able to fight an infection. However, the earlier the immune cells receive the strength to fight infection, the less are the long-term consequences.

Amicapsil-SCI is effective on all wound types, can reduce allergic skin reactions and is suitable for self-care, providing independence. Amicapsil-SCI can also control a wound on top of osteomyelitis, thereby reducing risks of sepsis and further spread of infection. Controlling the tissue infection also reduces frequency and severity of autonomic dysreflexia. Amicapsil-SCI does not require extended bedrest.

Amicapsil-SCI is the only wound product that has been evaluated in SCI, it is the only product that has demonstrated efficacy in treating the wounds in SCI-persons, and it is the only product approved for treating wounds and pressure ulcers in SCI-persons.

See case-reports using Amicapsil-SCI

Amicapsil-SCI

A new clinical study has found that Amicapsil-SCI is able to treat wound infection and support tissue regeneration:

  • Wounds without osteomyelitis (bone infection): Amicapsil-SCI healed all wounds.
  • Wounds with osteomyelitis: Amicapsil-SCI removed soft tissue infection and regenerated new tissue, reducing the wound to a draining fistula; this reduced the amount of tissue that needed to be removed during surgery for the osteomyelitis, which improved prospects of rehabilitation.
  • Amicapsil-SCI is suitable for teletreatment, providing freedom and independence as individuals can decide themselves when and where to perform dressing changes.
  • No requirement for extended or continuous bedrest, which has detrimental health consequences. All other approaches require immediate and full bedrest.
  • Reduced frequency and severity of autonomic dysreflexia.
  • Reduced risk of septicaemia and sepsis.
  • High prevalence of pressure ulcers immediately following injury severely impact long-term rehabilitation outcomes. Access to effective treatment that ensures rapid resolution, allows timely enrolment in rehab maximising future independence.

A key clinical finding was also that, if treatment is initiated before the wound is 2 months old, Amicapsil-SCI achieves stable closure in all wounds.

The data also showed that savings in the order of 85 to 90% could be obtained with the use of Amicapsil-SCI.

What are the official recommendations for treating pressure ulcers?

National Institute for Clinical Excellence (NICE) guidelines recommends:

1) Systemic antibiotics should not be used to treat a pressure ulcer.

2) Topical antiseptics or antimicrobials should not routinely be used to treat a pressure ulcer.

3) NPWT (the pump) is not recommended for routine use on pressure ulcers, except to control the exudate.

4) NICE recommends considering moist wound care (covering the wound with an occlusive dressing). However, for infected wounds this is not an option because the moist environment will exacerbate an infection (https://www.ncbi.nlm.nih.gov/pubmed/28532812).

In conclusion, there are no data to support the use of any of the existing approaches for the treatment of pressure ulcers. This is in line with the recent study by Guest et al. (2018) that only 14% of infected pressure ulcers heal within the first 12 months. The use of antibiotics and antiseptics for other wound types have, in a similar manner, not demonstrated any clinical effects, which led both the FDA and NICE in 2016 to conclude that antibiotics and antiseptics are not effective for treating infected wounds.

Antimicrobials are currently standard-of-care for pressure ulcers, but in the presence of resistant species they will make the infection worse.

Examples of wounds treated with standard-of-care, i.e. antimicrobials and with Amicapsil-SCI

New pressure ulcer on buttock - December 2019 After daily treatment with PHMB and silver - June 2020 - osteomyelitis developed
August 2019 Iodine twice weekly - June 2020
August 10 Many types of treatments tried - February 26

Examples of wounds deteriorating with standard-of-care treatment.
Top row: Wound washed daily with Prontosan followed by application of silver dressings;
Middle row: iodine treatment twice weekly - the wound appeared in May and treatment with iodine was started in June and was has already by August deteriorating;
Bottom row: long array of dressings and NPWT were tried, but unsuccessfully.

 

Day 0 Day 17 Day 114
Day 0 Day 35 Day 57

Examples of 2 wounds treated with MPPT in SCI-persons.
Top row: full-thickness burn on heel resulting from placing foot on hot water pipe. The wound was fully closed in about 4 weeks and remained closed as shown by the final picture.
Bottom row: 8 week old grade 4 pressure ulcer, which would not close with use of Manuka honey. MPPT was with once daily application able to achieve closure in 8 weeks.

Baroness Masham of Ilton, founder and president of SIA (UK Spinal Injuries Association), requests Amicapsil on the NHS during debate in House of Lords.


“It is amazing stuff that Amicapsil.
” VH (patient)

"It's no exaggeration to say that Amicapsil is a miracle cure. My paraplegic husband had been bed bound for NINE WEEKS due to a deep pressure sore on his buttock, which, using various gels, packing, dressings and other standard wound care techniques, had not improved at all. When we discovered Amicapsil and insisted on trying it the results were astonishing. My husband's pressure sore was treated with Amicapsil for just 3 days and by the 6th day it had reduced in size and depth by 90%. Finally we had found the cure for this debilitating and seemingly untreatable wound in such a simple and painless treatment. We can't recommend it enough, THANK YOU AMICAPSIL!" BB

Individuals with restrictions to movement are most at risk of pressure injuries. Therefore, pressure injuries are a serious complication of spinal cord injury (SCI) and can seriously impact the person’s quality of life. They may disrupt rehabilitation, prevent the person from attending work or school, and interfere with community reintegration.

When a pressure ulcer is severe and not treated aggressively it can lead to further disability, e.g. reduced mobility, dependence, surgical intervention, amputation, fatal infection.

It has been estimated that pressure ulcers can account for approximately one-fourth of the cost of care for individuals with SCI.