Case StudySilken

Practial issues with negative pressure therapy systems

Negative-pressure wound therapy is becoming more and more common in the treatment of difficult and chronic wounds. The number of indications for use of this form of treatment, as well as the number of patients who undergo the therapy continue to grow, and one should not expect this tendency to change.

A significant problem with the negative- pressure therapy is that the system may be leaky and thus it may prevent the therapy from being effective. The leakiness may be caused by a leak of wound contents. In case of abdominal wounds, especially such with fistula complications, the volume of the contents may be considerable. They may contain the intestinal contents and pancreatic or stomach juices. If the secretion leaks under the (external) adhesive film, the film will quickly become unstuck and make the system leaky to air, loosing suction. Furthermore, one should remember that the secretion may lead to significant irritation of the skin, and thus cause inflammation, epidermis defects, ulceration or necrosis. Clearly, it also causes great pain.

What is an ideal skin barrier for use with negative pressure therapy?

The optimum procedure to adopt in case of wounds with large secretion volume, and open abdominal wounds in particular, is formation of a ‘barrier’ that will prevent the leak of contents outside the foam.

These contents are later effectively removed from the foam with the use of the negative-pressure equipment. Below there is a list of criteria that a ‘perfect barrier’ should satisfy:
• It should be easy to apply, preferably with the use of one hand.
• It should be completely leakproof, i.e. hydrophobic.
• It should be flexible and easy to shape.
• It should remain flexible for the entire time it is fixed within the dressing.
• It should fit tight against the skin, but it should not stick to it.
• It should not stick to the gloves.
• It should be easy to remove (it should not stick to any surface).
• It should be neutral for the skin (it should not cause allergies).
• It should not react with the polyurethane foam and adhesive film (elements of the negative-pressure dressing).
• It should be safe for sensitive organs, such as the intestine or blood vessels, in case of direct contact (clinging).
• It should not absorb toxins, chemical compounds, and it should not constitute a culture medium for bacteria.
• It should be odourless and devoid of colorants that could trigger skin colour changes or changes in the colour of the secretion.

The SILKEN silicone gel, which we have applied in the clinical evaluation, satisfies all the above criteria. Below there are examples of its practical application.

Using Silken around multiple intestinal fistulas with negative pressure therapy

The patient has wound healing complications after a laparotomy, and stoma formation. Secretory and intestinal contents leaked from the abdominal wound (intestinal fistula) which caused permanent leakage of the contents under the stoma bag. The bag became unstuck and the intestinal contents from the stoma reached the wound. The application of SILKEN silicone gel made the negative-pressure dressing leakproof, protected peri-wound skin and significantly improved the effectiveness of the negative-pressure therapy.




A large number of skin outlets of intestinal fistulas around the laparotomy wound. Secretion of intestinal contents (small intestine) that irritates the skin around the wound and causes pain. The application of negative- pressure therapy with the use of a polyurethane foam directly on the wound was not possible (further skin irritation, growth of granulation tissue in the foam), the use of a nonadhesive barrier reinforced the leak of contents under the film (barrier) and reduced the effectiveness of negative-pressure therapy. The application of SILKEN silicone gel that prevented intestinal contents from leaking outside the foam increased the effectiveness of negative- pressure therapy and extended the lifetime of the dressings (it extended the time between the change of dressings) reducing costs and enhancing the comfort of the patient.





Using Silken on a peri-anal fistula with negative pressure therapy

Patient after removal of external outlet of perianal fistula. It was necessary to secure the skin around the area of the removal, seal the dressing and prevent it from ‘sticking’ to the edge of the skin. The application of SILKEN silicone gel enabled effective and safe use of negative-pressure therapy in the so-called difficult location, and it significantly accelerated wound healing.




High output wound uses for Silken gel

In the efficacy analysis performed so far, it has been found that the SILKEN silicone gel is highly effective in all cases – 3 patients subject to open abdomen treatment, 2 patients with perianal wounds, 2 patients with bedsores. SILKEN satisfies all the criteria of a ‘perfect barrier’, it is safe (no reactions, intolerance or adverse events) and well tolerated by the patients.

SILKEN can be used as a support in treatment of complicated and chronic wounds, especially with high volume of exudation (for example open abdomen with fistula).

  • Improve the fixation of the vacuum wound dressing around the wound
  • Protect the margin of the wound from stool and fistula exudation leak
  • Seal the negative pressure therapy system
  • Is easy to apply, did not connect with the skin and gloves,
  • Doesn’t irritated the skin
  • SILKEN can also be used in fistula treatment to seal external leak of the fistula and reduce uncontrolled output into the wound.

SAMPLE: Silken Silicone Stoma Gel 8g Tube


Innovative use of silicone technology to produce a soft silicone stoma gel that fills surgical scars, skin folds, creases and uneven surfaces, removing in one piece when fully cured. Allows the skin to breathe and remains soft and flexible to ensure comfort