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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.

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 (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 is effective on all wound types, can reduce allergic skin reactions and is suitable for self-care, providing independence. Amicapsil can also control a wound on top of osteomyelitis, thereby reducing risks of sepsis and further spread of infection.

Amicapsil and SCI

A new clinical study has found that Amicapsil in SCI-persons was able to remove the wound infection and reduce wound size considerably, but the final outcome varied:

1) Grade 1-4 wounds and pressure ulcers less than 2 months old, all achieved stable closure without further complications. Duration of treatment was from a few days to 2 months, depending upon wound grade, size and number of bladder/bowel accidents.

2) All grade 3 wounds, including older wounds, closed, but it could take longer to achieve this as the infection was more settled into the tissue.

3) Grade 4 wounds older than 6 months would close if there was no osteomyelitis. However, the time to reach closure would depend upon the number of tissue abscesses, number of bladder/bowel accidents and the individual person.

4) Grade 4 wounds with osteomyelitis would reduce to being a narrow exit tract through which infectious material from the bone could escape. Infective matter is continuously being released from the infected bone and it needs an exit passage to the surface - if not, it will remained lodged in the tissue can cause the creation of a wound. By forming this exit tract, it was possible to reduce the wound to this narrow passage and to keep the tissue free of infection. This greatly reduced the risks of blood poisoning, prevented continued deterioration of the area and the spread of osteomyelitis to new areas.

In the study, two individuals had problems with autonomic dysreflexia. In one, it disappeared with the use of Amicapsil and in one, with prolonged episodes of life-threatening rise in blood pressure three times daily, Amicapsil reduced it in frequency and severity and it became possible to control the AD with medication. Amicapsil does not have a direct effect on autonomic dysreflexia, but the episodes can be triggered by an infected wound, particularly in connection with dressing changes. So, by reducing the tissue infection, the autonomic dysreflexia was reduced.

The study also found that Amicapsil was able to effectively treat wound infections, including by the multi-resistant species P. aeruginosa, K. pneumoniae and S. marcescens. K. pneumoniae and S. marcescens both cause the formation of small tissue abscesses in SCI-persons due to the immune deficiency. These abscesses are gradually emptied and removed, but it can be a time consuming process for which reason early treatment is highly recommended.

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

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 are still widely used. The findings have huge cost implications as most acute wounds only required £85-£130 worth of Amicapsil to reach closure, whereas the annual cost of treating a pressure ulcer with standard-of-care is close to £11,000 - not to mention the personal implications.


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, according to NICE.

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

3) NPWT (the pump) is not recommended by NICE 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

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.

 “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.