Product Facts

Acapsil is a white odourless powder to be applied directly to the surface of wounds and ulcers that cannot be sutured or where the sutured wound has sprung open.

Acapsil is used where normally antibiotics or antiseptics would have been used, e.g. gentamicin, iodine (cadexomer, povidone), silver (Ag), PHMB (polihexidine), octenidine, honey, Manuka honey, chlorhexidine and DACC (Sorbact).

Acapsil removes the bacterial and fungal inhibition of the immune system. This returns control of the wound and the wound environment to the immune system which can now efficiently combat the infection and promote healing.

Acapsil supports 4 processes – at the same time

♦  Autolytic debridement.

♦  Infection removal - without the use of antibiotics and antiseptics.

♦  Infiltration removal – i.e. clears the affected deeper tissue in the entire wound region.

♦  Granulation and epithelialisation.

These 4 processes are required for a wound to heal.

Antimicrobial resistance / AMR

♦  Acapsil will remove antibiotic-resistant infections.

♦  Acapsil will not contribute to the creation of new resistance.

Suitable for wounds with these characteristics:

For all types of wounds to heal by secondary intention - regardless of aetiology.

♦  Infected wounds

♦  Necrotic wounds

♦  Wounds with low to high level of exudate.

♦  Deep cavity wounds and flat/shallow wounds.

♦  Undermining, sinuses, fistulas and other tunnelling.

Suitable for difficult-to-dress areas.

Wound types

♦ Infected necrotic wounds

♦ Dehisced surgical wounds

♦ Trauma wounds

♦ Abscesses and carbuncles

♦ Diabetic foot ulcers

♦ Venous leg ulcers

♦ Pressure ulcers

♦ Burns

♦ Pyoderma gangrenosum

What Acapsil does

External facing regions of our body work in synergy with the microbes of the environment to protect our body. On the skin, and hence in wound healing, this means that the ever changing skin-microbiome (the ecosystem of bacteria, fungi, viruses and mites) is necessary and must be conserved and nurtured in the best possible way. If the government of the microbiome is taken over by a specific strain of microbes, i.e. if the balance of the microbiome is disturbed, an infection arises. An infection on the skin or in a wound is removed by restoring the balance between the thousands of different inhabitants of the microbiome so that they all thrive without dominating. Only the immune system knows what the right balance is on that particular spot of skin/wound. Consequently, the immune system must be allowed to govern the microbiome and maintain the balance.

Bacteria and fungi use toxins and enzymes as weaponry against other microbes and the immune system to gain control. As protective armour against the immune system the bacteria and fungi hide inside a biofilm that acts as a shield or fortress that cannot be penetrated by the immune cells (or by antibiotics).

Acapsil removes the damaging toxins and enzymes whereby the immune cells regain their strength and abilities; and

Acapsil disrupts the shielding biofilm. This allows the newly strengthened immune cells to enter the biofilm and selectively remove unwanted or excess microbes. This restores the balance of the microbiome which again will promote healing.

Therefore, Acapsil works by returning the power over the healing process to the individual’s immune system – this makes Acapsil a passive immunotherapy.

Classification 

Acapsil is classified as a medical device and approved for use in humans in the EU.

Storage

Acapsil is temperature sensitive and needs to be stored refrigerated.

Evidence

Randomised comparative clinical trial with 266 patients

Acapsil was compared to antibiotic and antiseptic. Acapsil reduced time for removing infection and starting healing by 60% and number of hospitalisation days by 31% relative to these two major product groups.

Clinical audit at Bristol University Hospital

10 patients with dehisced surgical wounds. All wounds proceeded towards healing after 3 to 5 days with Acapsil and all closed. Standard of care would have been 1 week with UrgoClean plus 2 weeks with TNP (pump) to reach a similar stage where the wound could proceed towards healing – assuming no complications.

7 NHS community care and out-patients case-reports

The case reports were chronic wounds that proceeded towards healing following Acapsil. Cases included a chronic pressure ulcer, a 5 year old painful diabetic foot ulcer on the plantar (underside) heel, and a highly painful venous leg ulcer. In both cases with severe pain, Acapsil reduced the pain immediately and after 3 days and 3 weeks, respectively, the pain had completely disappeared.

Series of case stories from the veterinary world.
Preclinical study in wound healing model

This in vivo study had the same outcome as the clinical study.

Safety

Acapsil is safe to use for the healthcare professional as well as for the patient.

No serious adverse events and allergic reactions have been seen and no contraindications established.

Ingredients

The ingredients of Acapsil are well known and approved food supplements with NO known cytotoxicity (toxicity to cells), carcinogenicity (formation of cancer) or mutagenicity (change of DNA in genes) or risk of allergies.

Clinical use

Acapsil has been shown not to cause wound irritation, sensitisation or bleeding.

Acapsil has caused no damage when used on exposed bone, tendon and fascia.

Acapsil will not affect sutures.

Acapsil is not absorbed from the wound into the body. It can remain on the wound, where it gradually will fall off as the wound closes.

Acapsil can be rinsed off with water or wiped off with a moist swab.

When the wound is clean and Acapsil application is, therefore, discontinued, the dry Acapsil can remain on the wound surface and will fall off in small flakes as healing progresses

Acapsil does not cause pain when applied to the wound.

Acapsil does not cause pain at dressing changes. If the entire wound surface and edges have been covered with Acapsil, the secondary dressing will not stick to the wound surface but be easily removed.

In rare cases when applied onto exposed nerve fascicles, pain can develop. In that case, rinse with water and apply a thinner layer.

Keeps an optimal healing environment – not too wet, not too dry

Acapsil removes wound exudate by means of capillary forces. Capillary forces can be very strong, as is the case in Acapsil, but they are only effective as long as excess fluid, i.e. exudate, is present. They stop automatically when excess exudate is no longer present and therefore the wound is not over-dried and the wound bed is not damaged.

Resistance

Acapsil does not make use of any antiseptic or antibiotic substances.

Acapsil poses no risk of contributing to the creation of new antimicrobial resistant strains.

ISO 14971:2012 Risk Analysis

A risk analysis carried out to the standards of ISO 14971:2012 has found Acapsil to be” Inherently Safe by Design”. This means that the components and the way they are used in Acapsil have not been found to be associated with any known risks.