Medika SA - Clinical Data

Clinical Data

Below are abstracts from various different clinical studies on our products. Full versions are also available only on request.

Melladerm Plus Phyto is an effective, safe and clinically proven wound care ointment. It contains 48% medical grade honey as the main active ingredient. To determine effectiveness, the bacteriostatic efficacy, pH and compatibility was verified.
It was concluded that Melladerm Plus Phyto is effective against P. Aeruginosa, E.Coli, S.Aureus and MRSA. The pH is 4.30 (SD: ± 0.39), low enough to prevent microbial colonization but still high enough to create the optimum wound healing environment. In chronic wounds the pH is low enough to inhibit protease activity - facilitating the wound to enter the next phase of healing.
Melladerm Plus Phyto is proven to be compatible with most commonly used medical products as well as the rest of the Melladerm range.
To determine product safety, cytotoxicity, skin sensitization and irritation tests were conducted. It was concluded that Melladerm Plus Phyto proved to be non-cytotoxic and will not cause skin irritation or sensitization.
In clinical practice Melladerm Plus Phyto has shown to decrease measures of the wound margins and improve granulation and epithelialisation. Additionally Melladerm Plus Phyto showed to reduce odour, infection, exudate and facilitate debridement.

Melladerm Gel Phyto

Melladerm Gel Phyto is an effective, safe and clinically proven wound care gel. It contains 40% medical grade honey as the main active ingredient. To determine effectiveness the bacteriostatic efficacy, pH and compatibility was verified. It was concluded that Melladerm Gel Phyto is effective against P.Aeruginosa, E.Coli and S.Aureus.
The pH is 4.43 (SD: ± 0.84), low enough to prevent microbial colonization but still high enough to create the optimal wound healing environment. In chronic wounds the pH is low enough to inhibit protease activity facilitating the wound to enter the next phase of healing.
It was also concluded that Melladerm Gel Phyto is compatible with the most commonly used medical products as well as the rest of the Melladerm range. To determine product safety, cytotoxicity, skin sensitization and irritation tests were conducted. Melladerm Gel Phyto proved to be non-cytotoxic and will not cause skin irritation or sensitization.
In clinical practice Melladerm Gel Phyto has shown to keep the wound clean and to be effective in decreasing infection, and increasing granulation and epithelialization.

Melladerm Mesh / Melladerm Mesh with Film

Melladerm Mesh is an effective, safe and clinically proven wound care hydrogel. It contains 30% medical grade honey as the active ingredient. To determine effectiveness, the bacteriostatic efficacy, pH, compatibility and absorption capacity was verified.
It was concluded that Melladerm Mesh is effective against P. Aeruginosa, E.Coli and S.Aureus. The pH is 7.02 (SD: ± 0.06). A wound at the granulation phase of healing requires a pH of 6.5 to 7.8. The pH of Melladerm Mesh is optimal for these wound as well as wounds at the end of the inflammatory phase.
It was also concluded that Melladerm Mesh is compatible with the most commonly used medical products as well as the rest of the Melladerm range.
It was found that Melladerm Mesh absorbs up to 3869.048% its own weight over 24 hours. This absorption capacity is ideal for a wound with light to moderate exudate and maintaining a moist wound healing environment.
To determine product safety, cytotoxicity tests were conducted. Melladerm Mesh proved to be non cytotoxic and was found to significantly improve cell proliferation.
In clinical practice, Melladerm Mesh has shown to assist in limiting infection and improve debridement, granulation and epithelialization.
The introduction of the new Melladerm Mesh with film will simplify application and elliminate the need for a secondary dressing.

Phytopain

Phytopain Oil is a topical wound analgesic that is indicated for topical pain relief on acute, chronic, burn wounds and other wounds caused by trauma.
In the majority of cases, pain signals are first generated from peripheral nerve fibers and then transmitted to the central nervous system. Once in the central nervous system, the pain signal is modulated so that it is ignored, moderated or enhanced. In order to effectively treat pain, both peripheral and central receptors may have to be addressed. There is ample evidence which suggests that by treating peripheral receptors alone, central receptors are influenced.
When pain-modulating receptors are made more excitable, the pain experience is upgraded. Chemical mediators such as Substance P, Alpha agonists and antagonists, GABA agonists, and free radicals can affect these modulating receptors. This analgesic protects the nerve-endings which act as a receptor antagonist. This action then causes the inhibition of the pain signal by preventing the modulators which causes pain, to bind to the receptor site. This in turn causes pain alleviation. It also acts as an anti-inflammatory. PHYTOPAIN OIL has antimicrobial and antibacterial properties.
Acute and chronic wounds. E.g.: abrasions, skin tears, pressure ulcers, venous ulcers and arterial ulcers, diabetic ulcers, burn wounds (1st, 2nd degree), post-operative wounds and other external wounds caused by trauma.

MellaSorb Granules

MellaSorb consists of an absorbent hydrophilic powder, which act as a cavity filler and an exudate absorber. It can be used in medium to high exudating wounds.
MellaSorb absorbent powder is a highly absorbent hydrophilic polymer capable of absorbing large amounts of exudate and retaining the exudate in the matrix even under high pressures. The aqueous fluids remain trapped in the polymer matrix and can only be removed by evaporative drying or solvent extraction. Therefore, when used as a wound dressing, MellaSorb protects the wound tissue and the surrounding peri-wound area from maceration and degradation. MellaSorb helps to create a moist wound healing environment.
MellaSorb Granules are indicated for heavily to moderately exuding wounds. Can be applied as a cavity filler.

Flavonix Cytoflamm Gel

Flavonix Cytoflamm Gel comprises a combination of agents that target two areas identified as obstacles to wound healing: exuberant inflammation and bacterial biofilm formation.
Chronic wounds are typically characterised by an increased release of matrix metalloproteinases (MMP’s), proteolytic enzymes released by neutrophils which overwhelms growth factor concentrations and reactive oxygen metabolites (ROM), when not neutralised effectively, damage proteins and cells in the surrounding extracellular space. Both these factors lead to increased inflammation of the wound bed.
Bacteria as we traditionally know them begin as single seeds of a (planktonic) bacterium. They express proteins and structures for motility (flagella) and attachment (fimbria). However, in chronic wounds, the bacterium often takes on a different form. Small numbers of these single planktonic bacteria adhere to the surface of the wound by attaching to the exposed extracellular matrix; they multiply and develop over time into microcolonies. These colonies then aggregate into larger groups known as biofilms. The biofilm bacteria are encased in an extracellular polymeric matrix (EPS) which they manufacture themselves. Biofilms are generally resistant to antibiotics. Studies have proven that 60% of chronic wounds contain biofilms.
Both the inflammatory and biofilm components can lead to a state of chronicity. The effective control of inflammation and the elimination of biofilm restore the balance to the wound bed, reducing inflammatory cytokines and increasing growth factors, thus promoting healing. The anti-inflammatory components (Oleuropein, Baicalein, Witch-hazel, Aloe Vera) combined with the agents effective against bacteria and bacterial biofilm (Farnesol, Xylitol, Honey) provide a unique formulation of agents targeting two components that can markedly impede wound healing. This is a new area for wound dressing targeting and introduces a unique spectrum of active wound dressing agents (Bioflammacides)

KeraGENtrix

KeraGENtrix Temporary Skin Substitute is intended for use as a temporary cover for healing partial-thickness burns and donor sites. It can also be used as a temporary cover for full-thickness burns prior to the placement of skin autografts. KeraGENtrix is a bilayered membrane that facilitates epithelial migration across the surface of partial-thickness burns. The inner layer consists of a 3-dimensional knitted nylon scaffold coated with type 1 bovine collagen peptides. The outer temporary epidermal substitute layer is made of an engineered silicone layer. This layer protects the wound bed from external insults and maintains a moist wound healing environment. Collagen containing dressings provide a temporary protein scaffold for a new scar tissue to embed and heal the burn wound.
The device is classified as a Class III medical device. Southern Medical (Pty) Ltd believes the product has met the essential requirements for the Medical Device Directive (93/42/EEC Council Directive of 14 June 1994).
Morphological analysis has been done by the University of Pretoria, Department Anatomy, Division Cell Biology, using a Scanning Electron Microscope (SEM). Sensitive antibody based analysis has been performed to verify the presence and quantity of collagen, and cytotoxicity levels have been ascertained and deemed safe in Southern Biotech’s own Class 100 cellular testing facilities using Normal Human Fibroblasts. Clinical trials have proven KeraGENtrix to be user friendly, medically effective and cost effective.