Amicapsil-SCI and acute and chronic wounds, pressure ulcers and burns
Amicapsil-SCI can heal and close acute and chronic wounds, pressure ulcers and burns in SCI-persons. 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. Therefore, if you have a wound and worry about osteomyelitis start treatment immediately - DO NOT wait for diagnostic tests for osteomyelitis: Osteomyelitis may develop while you are waiting for the test results and none of the existing diagnostic techniques are accurate.
In a clinical trial with Amicapsil-SCI in persons with SCI, the closure rate was 100% for acute and chronic wounds, pressure ulcers and burns, when Amicapsil-SCI was used correctly. In most of the cases, the individual, family, or carers were responsible for the daily dressing changes with remote support by wound experts to ensure the treatment process was conducted correctly.
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| Wound extending towards the bone, where it may cause osteomyelitis if not stopped in time. | Wound treated with Amicapsil. Clinical findings have shown that Amicapsil can treat acute and chronic wounds, pressure ulcers and burns. In a clinical trial, the closure rate was 100% if used correctly and before osteomyelitis developed. |
Osteomyelitis development
Osteomyelitis is infection in the bone. It can develop:
1) from the outside, if an infected wound extends down to the bone and infection enters the bone. A wound is like an iceberg – most of it is below the surface and out-of-sight, which means that you cannot judge how deep the wound is by looking at the surface. A study found that one third of grade 4 wound, i.e. a wound that has reached muscle, give rise to osteomyelitis (Rennert et al. 2009) and that the wound responsible is usually only 4 months old (from first detection) and can be as little as 2 weeks old (Rennert et al. 2009; Russell et al. (2020).
2) from the inside, in two ways:
A) if a pressure causes injury to the soft tissue next to the bone, the injured tissue becomes infected, and infection spreads to the bone.
B) If infection spreads via the blood from another area of the body and settles in the bone.
From the outside:
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| Wound has reached the bone and has caused osteomyelitis. |
From the inside via pressure (A):
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| A deep pressure injury has formed above the bone and become infected, causing the development of osteomyelitis. |
From the inside via the blood (B):
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| Infection has spread via the blood and has settled in the bone, where it has caused osteomyelitis. |
An osteomyelitis will constantly release infectious and corrosive debris into the soft tissue next to the bone. Initially, the body may be able to absorb this debris but after a while, as the volume of debris increases, it will create a canal, a draining fistula, through which the debris can escape to the surface of the body and be disposed of. Consequently, if osteomyelitis develops from the inside, an estuary in the likeness of an ulcer will sooner or later appear on the skin as it discharges (drains) the debris from the infection in the bone through the tunnel (fistula) onto the skin. Such a perceived ulcer will naturally already be extending down to the bone. It is referred to as a draining fistula.
Osteomyelitis and the associated ulcer – the draining fistula
A draining fistula is not a wound, because it is caused by osteomyelitis and it can only close by surgically removing the root cause, i.e. the osteomyelitis (BMJ Best Practice). Because the debris is highly toxic and infectious, a draining fistula often results in a wide-spread festering soft tissue infection causing tissue break-down, malodour, exudate, and a high risk of sepsis.
Osteomyelitis from the outside:
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| The osteomyelitis is small and only releases a small volume of debris into the tissue. This debris may seep within the tissue to the surface along ever-shifting changeable paths too narrow to identify, or it may form a narrow draining fistula, usually in the path followed by the original penetration. This can be difficult to recognise. | As the infection grows in the bone, an increasing volume of exudate is discharged, causing the draining fistula to expand in size. |
Osteomyelitis from the inside:
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| A pressure injury can form out-of-sight on top of the bone or infection can spread via blood. This can lead to an infection in the bone even prior to being evident on the surface. | As the infection grows in the bone, an increasing volume of exudate is discharged, causing a draining fistula to develop and expand beneath the skin surface. At some point this will break through the skin. |
A wound (ulcer) and a draining fistula may look similar, but they are fundamentally different as a wound is damage to the skin and tissue, whereas a draining fistula is a canal through which infectious debris from the bone travels to the skin surface. The draining fistula can only be resolved by removing the infection in the bone. The wound associated with a draining fistula may be closed temporarily via surgery, but will always return if the osteomyelitis is not fully removed. None of the imaging tools currently available are reliably predictive in diagnosing osteomyelitis and even the tool considered the most reliable, i.e. bone biopsy is not fully predictive. Osteomyelitis does usually not show up in blood work and does not necessarily cause fever.
A draining fistula will often look like a wound or a discharging sinus, but it will refuse to close fully with Amicapsil and will often display characteristic signs such as tissue gorges in the wound surface and air bubbles or froth, caused by gas-forming bacteria, appearing in the exudate and on the wound surface. Antibiotics alone are ineffective in treating an osteomyelitis more than 6 weeks old (chronic) (BMJ Best Practice). In chronic osteomyelitis, antibiotics may transiently reduce the level of exudate, but this will frequently increase in volume and/or change in consistency when they are stopped. The antibiotics are likely to make the infection resistant and more aggressive.
Chronic osteomyelitis is known for its ability to cause reduced discomfort for long periods of time. However, it can change character quite suddenly, e.g. in connection with a course of antibiotics for a different condition or stress debilitating the immune system for a different reason for a period of time. When that happens, the osteomyelitis can grow quite rapidly and increase the risk of sepsis as well as the infection in the surrounding soft tissue.
The infectious debris from the bone is known to increase the risk of developing cancer in the tissue (Peng et al. 2020).
Russell et al. (2020) reported that the failure rate of surgery at a UK NHS hospital for osteomyelitis was 71% and that two thirds (64%) of the ulcers never healed, even after surgery was repeated. The median time of survival was only 2 years after first surgery if the wound did not heal (64%) and still only 7 years (36%) if it did heal. Panteli and Giannoudis (2017) characterise osteomyelitis as a condition that is managed and not cured.
Osteomyelitis is therefore a condition that is difficult to cure, and it can spread in the body via the blood. This means that preventing a wound from causing osteomyelitis is of utmost importance.
Amicapsil-SCI and osteomyelitis
The infection in the bone will constantly grow and release increasing amounts of infectious and corrosive debris into the tissue outside the bone. This leads to a growing draining fistula, which becomes increasingly uncontrollable. In some cases, the body itself is able to create a narrow canal that controls the transport of the debris from the bone to the surface. However, in most cases, the infection and its harmful exudate causes the soft tissue to break down and display an increasingly infected, discharging, malodorous wound that keeps expanding and increasing in severity. This situation increases the risk of sepsis. Amicapsil can help as it removes the soft tissue infection caused by the osteomyelitis and this allows the body to rebuild the tissue and create a stable canal between the bone and the skin surface. Amicapsil will keep the soft tissue lining this path free of infection despite the infectious, corrosive debris passing through it, thereby lowering its harmful impact:
1) This rids the wound of the dead and dying tissue and regenerates new healthy tissue. By doing so, the large uncontrolled wound transforms into a much narrower draining canal.
2) This reduces the risk of sepsis, i.e. blood poisoning.
3) This reduces the level and frequency of autonomic dysreflexia, in particular blood pressure and spasms.
4) Extended bedrest is not needed for Amicapsil to be effective. Bedrest has severe negative impact on both physical and mental health and is incompatible with an active life.
5) Amicapsil is suitable for telemedicine, where the person, family or carers are responsible for the daily dressing changes combined with remote support by a wound expert. This reduces dependence on external nursing visits for dressing changes allowing freedom to perform the dressing change at a time and place that suits one’s own planned schedule and it eliminates waiting.
6) Reducing the size of the wound prior to surgery also reduces the need for or the extend of 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, e.g. making one more prone to future pressure ulcers. Another repercussion is when the donor site refuses to heal.
7) Preliminary evidence indicates that the use of Amicapsil for at least some months before surgery increases the probability of wound closure following surgery substantially.
Depending upon the state of the draining fistula, when starting Amicapsil treatment, it normally takes around 2.5 months to reach a stable state. After this point, the daily amount used will have reduced considerably compared to the beginning of the treatment and will be fairly stable. However, if used very long term, it may slowly increase again as the osteomyelitis itself spreads and generates more debris that causes more harm. Also, long-term, new draining fistulas may develop as the osteomyelitis grows in extent and distance from the original fistula. A new fistula will also require treatment.
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| The continuous release of corrosive infectious debris from the bone into the overlying tissue leads to the tissue breaking down into 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. |
Examples of wounds treated with standard-of-care, i.e. antimicrobials and with Amicapsil-SCI
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| New pressure ulcer on buttock - December 2019 | After daily treatment with PHMB and silver - June 2020 - osteomyelitis developed |
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| August 2019 | Iodine twice weekly - June 2020 |
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| 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.
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| Day 0 | Day 17 | Day 114 |
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| 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 requests Amicapsil on the NHS in the House of Lords in order to fight AMR.