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Spinal cord injury – wounds, pressure ulcers and burns

Clinical data shows that osteomyelitis (infection in the bone underneath the wound) is a frequent, direct and fast developing consequence of pressure ulcers and that it is associated with substantial risk of irreversible general deterioration and death. It can, and often does, develop in less than two months after first detection of the ulcer. Therefore, fast and effective intervention to prevent this, is paramount.

 

A spinal cord injury disrupts the communication between the nervous system and the immune system. This means that the nervous system can no longer let the immune system know where there is an injury or an infection and this results in only half the usual amount (50%) of immune cells rushing to the area. SCI-persons consequently have a reduced ability to fight infection and to heal wounds. British Medical Journal, Best Practice (BMJ-BP) advises to suspect osteomyelitis in immunocompromised patients with a discharging sinus or previous orthopaedic surgery.

In SC injured persons, if a wound reaches muscle (grade 4), an infection in the underlying bone (osteomyelitis) will develop in a third (32%) of these cases (Rennert et al. 2009). Bone infection can only be removed by surgery – antibiotics alone are not effective (BMJ Best Practice).

Russell et al. (2020) reported that the failure rate of surgery at a UK NHS hospital for osteomyelitis is 71% and that two thirds (64%) of the ulcers never heal, even after repeated surgery. They furthermore reported that the pressure ulcers responsible for causing the osteomyelitis was usually only 4 months old (from first detection) and could be as young as 7 weeks old.

Therefore, preventing a wound or ulcer from developing osteomyelitis is of utmost importance.

Amicapsil-SCI and acute and chronic wounds

Amicapsil-SCI can close acute and chronic wounds in SCI-persons, if there is no severe underlying problem preventing closure, such as osteomyelitis or an anal fistula. It is important to start treatment as soon as possible if a wound appears: the sooner treatment starts, the quicker the healing, the less Amicapsil is needed, and the lower the risk of developing osteomyelitis.

Amicapsil-SCI and osteomyelitis

In osteomyelitis, the infection in the bone constantly releases infectious and corrosive debris into the tissue outside the bone. This leads to the formation of a large wound harbouring profuse infection. The wound cannot close fully without first removing the bone infection by surgery (BMJ Best Practice), but it is possible to control and minimise the damage and reduce the risk of sepsis caused by the infection.

Minor, but deep wound reaches the bone and causes osteomyelitis. Removal of the bone infection requires surgery.

 

The continuous release of corrosive infectious debris from the bone into the overlying tissue leads to the creation of a large wound. It can also lead to the creation of abscesses scattered in the soft tissue.

 

Amicapsil can remove the soft tissue infection and keep it controlled. This reduces the wound to a draining canal between the bone and the skin surface with the wound opening serving as the exit spot.

 

Amicapsil can remove the soft tissue infection caused by osteomyelitis and help the body create a narrow canal between the bone and the skin surface through which the infectious, corrosive debris can safely be transported without causing harm:

  • 1) This replaces a large uncontrolled wound with new healthy tissue and reduces the wound size to a narrow draining canal.
  • 2) It reduces the risk of sepsis, i.e. blood poisoning.
  • 3) It reduces the level and frequency of autonomic dysreflexia.

Russel et al. (2020) found that:

  • Nearly three quarter (71%) of patients who had surgery for their osteomyelitis, experienced failure of their surgery. Failure is understood as either requiring new surgery or requiring i.v. antibiotics due to sepsis.
  • The failure rates correlated with high infection markers, i.e. with high CRP in blood test.
  • Two third (64%) of the wounds did not close following surgery, despite having surgery repeated, and these patients would generally pass away within approximately 2 years from their first surgery.
  • This group correlated with the wounds that did not have enough soft tissue to permit the wound to be closed by suturing during surgery.

These two risk factors – severe infection (CRP) and considerable loss of soft tissue – can both be mitigated for a long time with the use of Amicapsil as Amicapsil reduces infection levels, and it restores soft tissue despite the underlying osteomyelitis.

Therefore, Amicapsil should be used prior to surgery for osteomyelitis to reduce the overall infection level in the soft tissue surrounding the wound as well as the size of the wound prior to surgery. This supports healing and a successful outcome of surgery.

Reducing the size of the wound prior to surgery also reduces the need for flap-surgery. The Flap is own tissue taken from a different part of the body and this can have permanent consequences. For example, the buttocks are frequently used, but they are needed for cushioning when sitting, and losing them can complicate sitting after surgery. Another consequence is when the donor site refuses to heal.

See: Now you can treat wounds and pressure ulcers in SCI – a general introduction to how Amicapsil works and why antibiotics can be dangerous.

See: Presentation from the 27th Australian and New Zealand Spinal Cord Society, Annual Scientific Meeting on the results of a study using Amicapsil-SCI for treating wounds and pressure ulcers in SCI-persons.

See: Case-reports using Amicapsil-SCI.

Extended bedrest is not needed for Amicapsil to be effective. Bedrest has negative impact on health and is incompatible with an active life.

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.

On MPPT

27th Australian and New Zealand Spinal Cord Society, Annual Scientific Meeting

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.