NH ( patient)
NH ( patient)
NH ( patient)
Only natural ingredients
Only natural ingredients
Only natural ingredients
US FDA 2016
US FDA 2016
US FDA 2016
In connection with publication on MPPT, the
In connection with publication on MPPT, the
In connection with publication on MPPT, the
MPPT in the treatment of wounds and pressure ulcers in spinal cord injured patients
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.
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.
- 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.
The following are examples of wounds included in the study.
Paraplegic patient had 9-week old pressure ulcer on buttock. Hydrogel, manuka honey and Flaminal Forte, respectively in combination with Durafibre had been tried, but the wound remained non-healing and slowly deteriorating, i.e. expanding. Acapsil was applied once daily for 3 days and initiated healing. From Day 0 to Day 6 there was over 90% reduction in the volume of the wound and the wound continued towards closure.
Please see video above for the full story.
Patient was a woman in her late thirties C5 complete quadriplegic, 20 years paralysed. The pressure ulcer was a category 2 of 1.5cm x 1.4cm below the sacral area and had been persistent for 2 years. It had no tunnelling and undermining. It had once closed, however only to reopen. The patient had been on bed-rest for the 6 weeks period prior to Acapsil. Judging only from what was apparent to the naked eye, the ulcer seemed covered with a layer of tenacious biofilm.
Acapsil was applied once daily for three days (Day 0, 1 and 2). For the entire period until full closure, the wound was cleaned thoroughly daily with plenty of clean water (shower) and dabbed dry very gently. The wound was either left uncovered or covered with a plain gauze or an N-A (dry, permeable contact layer dressing) of the patient’s choice depending on the immediate activity that was to be undertaken. The patient was encouraged to leave the ulcer to the air as much as possible. She was also encouraged not to sit or lie on the wound but still to get out of bed for moderate amounts of time – with good use of cushions etc. Acapsil was applied once more later in the healing process, due to unforeseen circumstances. It immediately restarted healing.
It was evident that the biofilm disappeared within the first 2 days together with a small amount of non-viable tissue - this tidying process necessarily leaving the wound opening a tiny bit wider and deeper than before first application. The biofilm is a sign of the microbes having gained a strong foothold with infiltration of the deeper and surrounding areas by a variety of infecting agents. The tissue infiltration was gradually cleared over the following days. It was recognizable by the stretching and pulling of the surrounding skin as well as the flakes and scales appearing on the surrounding skin. The flakes and scales are a sign that the skin and the underlying tissue is regenerating and being substituted for healthier skin appearing rapidly underneath. The flakes and scales should be left in peace to fall off in their own time, which will be when the new skin underneath is sufficiently mature. After full closure of the actual skin opening, the wound, the skin continues to mature for approximately 6 weeks. It was also evident how the regeneration of soft tissue would also continue to progress underneath the new skin. This process is likely to take a similar amount of time.
The ulcer was fully closed (epithelialised) on Day 17.
Patient's statement on Day 17: “It is amazing stuff that Acapsil” VH
As a consequence of hospitalisation, ICU, in connection with initial spinal injury, an approximately 60-year-old man developed a sacrum pressure ulcer which very quickly expanded to a category 4. It became heavily infected, and over the following 15 months in hospital followed by 19 months in community care, the wound has needed daily treatment by usually specialty nurses mostly from tissue viability. Essentially, all available approaches to wound care have been tried including NPWT with and without instillation of saline, but it has proven impossible to close the wound. Judging from the history; the state of the wound; and the fact that chronicity in wounds is due to infection (Leaper et al. 2015) it is most likely that the patient by now has developed a very deep-seated infection that – given all the methods tried – has developed resistance to practically all available approaches.
In hospital the following products had been used:
Inadine, Kaltostat, Durafiber,Durafiber Ag,Allevyn Life, Allevyn Adhesive, Allevyn Gentle, Tegaderm foam, Sorbaderm, Debrisoft, Aquacel Foam, Promogran, Iodoflex.
In community, among others, the following products had been used:
Prontosan, Aquacel Ag, VAC pump, Inadine, Kaltostat, Durafiber, Durafiber Ag, Allevyn Gentle Border, Tegaderm Foam, Sorbaderm, Debrisoft, Aquacel Foam, Promogran, Iodoflex, PICO, Suprasorb, Medihoney gel, Packing ribbon, Manuka honey, Flamazine, Cutimed Sorbact, Flaminal Forte, Biatain Silicone, Kliniderm, Allevyn.
Goal of Acapsil trial:
The wound was being scheduled for surgery. The aim of the Acapsil treatment was to contain the spreading infection and reduce it as far as possible. This would allow for a reduction of the area to be excised as well as significantly increase the chances of success of surgery. Acapsil could then be used again immediately following surgery, in order to remove any remnants of infection and to keep the healing process progressing uneventfully.
This goal has been reached Day 21. While awaiting surgery, the further progress will be monitored.
While awaiting surgery, the wound is flushed with tap water daily and dabbed dry with a gauze. It is left to air only covered with a simple gauze and no antimicrobials are being used. So far, it has only needed a light, superficial dusting with Acapsil once, due to possible detection of odour.
The monitoring will continue until surgery.
Example of analysing wound status and progression
3.5-year-old category 4 sacrum pressure ulcer. 17x17 cm covered with bright red shiny skin and scar tissue with a relatively small opening in the centre. As most of the wound area is closed over by skin on top, the wound can only be evaluated from the colour, texture and temperature of the skin as well from the level, colour, texture and smell of the exudate. The 4 pictures below are identical, from Day 0, i.e. before start of Acapsil, and indicate the 4 main areas of the wound.
Day 0: The opening and the surrounding skin in the inner blue circle is deep purple and the texture is stiff and hard like cardboard in the entire area within the broad blue circle - the signs of cellulitis in old non-healing wounds. The inside of the wound is brown-yellow and necrotic. The cranial and right sides are undermined by 1 cm (blue line). The wound edges are curved downwards facing into the open cavity. The exudate level is very high. The wound is malodourous.
Day 21: Area1: All purple areas have changed to pink and the cardboard-like texture is gone – i.e. the cellulitis is cleared, fending off the acute risk of septicaemia. The skin is now skin-like and even the old scar tissue is well pliable. The inside of the wound is pink and granulating. It has granulated up from the bottom, the opening has reduced by one third from the distal end and the undermining along the right side has disappeared. The exudate level is reduced to being controlled by a cotton gauze. No smell is associated with the wound.
Day 0: The distal area of the wound show clear signs of widespread tissue infiltration.
Day 21: The area is now cleared of infiltration and the skin is normal in both texture and colour practically up to the wound opening.
Day 0: 2 sinuses of 4 and 5 cm, respectively, open underneath the undermining and run cranially under the skin as indicated by the blue lines. The entire area circled in blue is warm to touch, red, inflamed and swollen with cracked and fissured skin resembling miniature wounds - the signs of infectious infiltration.
Day 21: The acute skin infection is cleared and the skin is returning to its normal colour. The 2 sinuses run underneath the deeply infiltrated area making sure the body has a means to drain out the necrotic tissue and the debris created by the infection. The area has clearly reduced in redness and the swelling on left side is starting to reduce. The sinus tunnels have been deblocked and cleared of infection; this is witnessed by fresh tissue being brought out during probing. The sinuses need to remain open temporarily to allow for the regular drainage of infective debris until the entire area has been cleared from tissue infiltration. As practically the entire wound area is covered by skin, only the sinuses represent an opening for Acapsil to reach the distant tissue to support the immune system. The infection is 3.5 years old and judging from the colour of the exudate pushed out on different days, pockets of infection with different infective agents have broken of different days. The process of infection containment and removal is ongoing and, as the wound is 3.5 years old, this will take the immune system some time to penetrate all the pockets and get to the bottom of the infection in all directions.
Day 0: Two areas of dense, deep infectious tissue infiltration with no open sinuses running underneath, are outlined in blue.
Day 21: The deep-seated infectious tissue infiltration has contracted showing rather clear demarcation borders on both sides in the areas indicated in blue. There are no sinuses or other means for the body to rid itself of the waste products deriving from the ongoing infection removal process. On the right side, the infection is now contained and concentrated in two spots and the body has chosen to open the skin to the surface to rid itself of the waste products by this route. This will create a small wound which will be very easily controlled and closed with Acapsil. This strategy is therefore desirable, as it will lead to resolution of the tissue infiltration in the area. On the left side, the infiltrated area is also in the process of being contained and creating visible demarcation borders. It is still too early to predict whether the body will be able to get rid of enough debris through the obvious cracks in the skin or whether it will have to break through in a manner similar to the right side.
A 74-year-old lady had received very high doses of radiotherapy 35 years ago to treat cervical cancer. This had created an abscess which 35 years later, in March 2017, revealed itself as a sizeable patch of eschar (dry, black necrosis) on the right side of the lower back (Pict. 5 April 2017, see below).
Approximately a month and a half later (Pict. 20 May 2017), the patient developed toxaemia; was hospitalised to ICU (intensive care unit); and received iv antibiotics for 4 days where-after the abscess was surgically debrided, exposing an infected wound with a 10 x 2.5 cm opening. The depth was 6.5 cm without finding viable tissue at the bottom. The “floor” of the wound, as it appears in the pictures, was directly on top of bone suffering from chronic osteomyelitis. This bone infection needed to drain into the wound.
|5 April 2017||20 May 2017 – Day before surgical debridement|
For one month following this debridement, the wound was packed daily with Manuka honey and dressed with superabsorbents to resolve the remaining necrotic tissue and to promote healing. However, after a brief appearance of a few granulation buds at one edge (Pict. 13 June 2017), the wound regressed, grew in size to 12x3 cm and the necrotic tissue dried and formed a 1 cm thick dry and leathery layer on top of the entire wound. A severe, deep and wide undermining along half the perimeter of the wound developed and the skin significantly thickened and hardened (an indication of the potential presence of toxins). Broad purple-red wound edges and peri-wound area were evident, indicating high risk of cellulitis. The wound became increasingly infected and highly malodorous and the patient showed overall renewed signs of toxaemia (Pict. 23 June 2017).
|13 June 2017 – after 3 weeks with Manuka honey||23 June 2017 - Day -4 - four days before start of Acapsil|
On the 27th of June, Day 0, the use of Manuka honey was stopped and daily application of Acapsil was initiated. A MRI was performed, which identified a 20 cm deep 3 cm diameter tunnel, leading from the right-side bottom of the wound down along the right femur. This was running along the main vessels and nerves and was tightly filled with cheese-like slough. Similar to the hip-bone, the femur also suffered from chronic osteomyelitis and needed to drain into the tunnel. The wound was washed and Acapsil applied. After 24 hours, the overall signs of toxaemia had reduced (not disappeared) and the wound showed signs of granulation to the front rim at the leftmost corner, the “ceiling” and the “floor”(Pict. 28 June 2017, Day1).
|28 June 2017 - Day 1 - After 24 hours Acapsil||5 July 2017 - Day 9|
Over the following months, with some interruptions, the wound was thoroughly washed and Acapsil was applied more or less daily to roughly all accessible wound surfaces, including exposed osteomyelitic bone, undermining and as far possible into the tunnel until blocked by slough. It was covered with a permeable contact layer dressing and a 2-ply gauze.
The wound progressively cleared and granulation tissue and new epithelium around the wound edges appeared and grew gradually stronger (Pict 05 July 2017, Day 9). The malodorous infection of the entire wound resolved. The ongoing necrotizing stopped, large amounts of the existing necrosis dissolved via autolysis and the underlying viable tissue started to build up via steady granulation. (Pict. 23 July 2017). In the floor-area of the right hand side of the wound in front of the hole marking the entrance to the 20 cm deep sinus, an area gradually cleared very deep down until reaching viable tissue, including a 0.5 cm wide, 10 cm long and 4.5 cm deep ridge (Pict. 25 July 2017).
The left hand side of the floor area was situated on top of the osteomyelitic bone. This was cleared of the necrotic tissue whilst still preserving the white structured fascia on top of the bone. The chronic infection had deformed the bone structure to the degree that it was no longer smooth but butting up grey and brown protrusions through the fascia. Granulation started to grow back over the bone where the fascia was intact. (Pict. 25 July 2017)
|23 July 2017||25 July 2017|
|30 July 2017 - The area between the granulating “ceiling” and the white and structured fascia on the “floor” is a necrotized vein that is in undergoing removal by autolytic debridement.|
During the course of the following month, the wound would build strong new tissue from the entire ceiling and right-hand side of the wound (Pict. 02 August 2017) (Pict. 17 August 2017) as well as the right-hand side deep floor area in front of the sinus entrance (Pict. 29 August 2017 - 1). For reasons external to Acapsil and the wound, the left upper corner had up till now mostly been left uncovered with Acapsil during applications and was, therefore, lacking behind still needing to undergo autolytic debridement of necrotized non-soft-tissue, e.g. vessels (Pict. 29 August 2017 - 2).
|2 August 2017||17 August 2017|
|29 August 2017 - 1||29 August 2017 - 2|
After 2 months with Acapsil, 31 August 2017, the 20 cm deep sinus down the leg running along the osteomyelitic bone cleared of the remaining cheese-like slough and remained clean. Only one day later, there was a remarkable change in the purple-red coloured cellulitic peri-wound skin. The inflammation started to contract in width and the skin gained a healthy pink colour. At this point in time, the hardened skin along the entire bottom edge of the wound also started to slowly fuse at the bottom thereby starting to clear the undermining. Further, off-white coloured new epithelium generated on the edges themselves. Furthermore, the volume of the wound had reduced considerably (Pict. 02 September 2017).
|2 September 2017|
The high-risk issues in the wound had been resolved, the healing was progressing well, and it was decided to change the application regime to every other day.
The wound continued to move rapidly along the path of healing with granulations building from the ceiling; back wall; right hand side of wound; and floor area in front of the right hand sinus entrance (Pict. 13 September 2017) (Pict. 07 October 2017). The osteomyelitic left-hand side floor area was kept clean and granulation was slowly making its way over the fascia (Pict. 13 September 2017) (Pict. 17 October 2017 -1).
By mid October, the wound had reduced approximately 50% in volume (Pict. 17 July 2017-2); there were no signs of wound infection; and the patient was overall performing remarkably well.
|13 September 2017||7 October 2017|
|17 October 2017 - 1||17 October 2017 - 2|
For the duration of the period of Acapsil use, a consistent feature was that as soon as an area had been cleared of necrosis, it started to granulate. Granulation would always make its first appearance as a distinctive white layer of proliferating cells and over the following couple of days, this would turn pink as the angiogenesis took place and the granulation matured.
Another consistent trait throughout the period of removal of infection and necrotic tissue as well as tissue formation was, that the immune system would seem to work the deeper tissue and deposit the resulting waste as sloughy exudate on top of the wound, even on top of areas with strong granulation. The healing process was, therefore, assisted by a daily wash to remove this toxin containing waste material without causing damage to the forming granulation tissue.
The wound as a small part of a bigger clinical picture - Acapsil used for tertiary intention healing:
Due to the presence of extensive and chronic osteomyelitis (bone infection), the patient had been referred to the national specialist unit for osteomyelitis at Nuffield in Oxford. Osteomyelitis of this magnitude, severity and in the relevant area could only be treated via life-threatening major surgery and with uncertain future perspectives of quality of life for the patient. The consensus of the specialist team was, therefore, to try to manage - not cure - the osteomyelitis with the use of antibiotics. The success of this option would, however, depend on this extensive and infected body opening (the wound) being brought under control. Furthermore, as the infection of the bone would persist, it would always continue to drain microbes and their toxins into the wound. Therefore, a long-term solution to manage these conditions and avoid further infection or necrosis in the wound was sought for.
The wish-list for the wound set out by the specialist team in Oxford was to:
- remove all dead tissue and waste material originating from the infection (debride) as this is the ideal breeding ground for infections;
- remove the wound infection;
- maintain the wound clean without it growing in size or complexity; and
- keep infection and amount of toxins in the wound below the threshold of causing toxaemia.
At this point in time, Acapsil had accomplished all of these wishes and was continuing to keep the wound controlled and healing. All expectations had, consequently, been exceeded and the patient could go back to the team in Oxford with high hopes.
The patient and her family offered the following statement:
Testimonial for Acapsil.
21st October, 2017.
For the period from March 2017/October 2017.
35 years ago my wife was one of the first people to live through cervical cancer after having been given a few months to live. She was at Christies Hospital in Manchester and given a new treatment which included a very heavy dose of radiotherapy.
Seven months ago, this long forgotten radio-therapy resurfaced by creating various abscesses in her pelvis and thigh. When the surgeons opened up what seemed to be a large pressure sore, they were amazed to find a deep wound created by escaping radiotherapy infection from her pelvis and thigh. What they found was a rectangular wound that was 12 cms wide, 5 cms deep and 12 cms into her flesh at it’s deepest point which fed into a 20 cm sinus that ran into the bone. They decided it was too dangerous to continue clearing it and referred us back to the deep tissue viability team.
After a further two months, with the use of traditional methods there was little improvement and we firmly believed that my wife would die as the infection worsened. Nobody gave us any assurances that this was not the case. All they knew was that she had chronic osteomyelitis which seemed incurable without a deep tissue operation at the Nuffield Centre, which had less than a 50% chance of survival.
We were then introduced to a product called Acapsil. The manufacturer, at that time, thought the wound was too severe for its product to work, but we decided to take a chance. Nothing else was working. Within a month there had been a major improvement. Now, just after two months the wound and the sinus are almost totally clear; granulations are blooming and the flesh has closed down the wound by approximately 50%. Unbelievable. We have kept an accurate photographic record, always with community nurses present, of this amazing transformation.
The surgeons and doctors had said they couldn’t do anything with the wound in the condition it was in. We’re now going back to them with an almost clean wound. My wife is in little pain and full of hope as we wait to see what the surgeons and doctors now determine how they can prolong her life.
We’re not home yet, but without Acapsil neither of us believes we would have got this far.
JS and ES
The wound was taken off Acapsil treatment and the plan was to return to the original team in Oxford with a non-infected, granulating wound on top of osteomyelitic bone. Unfortunately, external circumstances prevented this re-evaluation of the wound and the patient’s clinical possibilities. After a short period off Acapsil, the wound started to break down due to the use of an antiseptic. See below. She was, consequently, put back on Acapsil treatment again in November 2017. During the following months, the wound continued to reduce in size whilst the Acapsil kept the adjacent infection at bay.
The patient now engaged with a consultant surgeon at the Royal National Orthopaedic Hospital who evaluated the wound itself and the soft tissue in the entire area, i.e. down along the femur, the entire right buttock region and the area along the spine. He judged the degree of infection, (tissue infiltration) to be sufficiently small and controlled, to make possible the surgical removal of the infected entire hip-bone, followed by closure of the wound. This procedure was performed in stages during October-November 2018. See picture below from 15th Oct.
MPPT is indicated also post-surgery, to ensure the graft takes and to prevent infection in the deeper areas.
Due to the extent of the surgical procedure, it was necessary to permit for a short period of rest before, the final plastic follow up with flap operation. This was performed in December 2018 and the patient arrived home in time for Christmas.