Passive Immunotherapy for Wound Infections and Wound Healing

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.

FDA (2016):

"The available evidence does not appear to demonstrate improved clinical outcomes from the use of antimicrobial dressings over non-antimicrobial dressings for the prevention or treatment of local wound infections or to improve wound 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 evaluation 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.

Clinical evaluation of MPPT in pyoderma gangrenosum

University Hospital Birmingham, UK, evaluated MPPT in three patients with chronic inactive stable PG ulcers.

Community care and out-patients case-reports

Acapsil has been able to initiate the healing of several non-healing wounds and ulcers, which had not responded to a wide range of approaches.

Preclinical study in wound healing model

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

Series of case stories from the veterinary world.

It’s not too much of an exaggeration to say Acapsil changed my life. From 4 weeks of absolute hell, in pain 24 hours a day, struggling at work and looking at possibly taking time off – to being pain-free, getting a full night’s sleep and back to normal at work.” NH

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