CE 0481 (appendix II, class IIb, acc. to regulation 4)
What is it and what is it used for:
LIGASANO® white is a therapeutically effective PUR foam material with a wide range of uses for wound care and prevention. The therapeutic uses are based essentially on 3 underlying physical principles:
Mechanical stimulus: Stimulates local blood circulation in the wound and where there is skin contact, thereby improving the supply of nutrients and oxygen in the wound area (activation of the wound) and acts as a preventative on skin which is still intact. Stimulates normal bodily functions at local level, especially in the case of inactive patients or where these functions are reduced. The mechanical stimulus lasts for up to 3 days, by which time LIGASANO® white should then have been changed.
Low-pressure tension: Low-pressure adaptation to contours, and even, minimised pressure on wound and body.
Specific suction effect: Absorbs excess fluid without the drying-out effect. Creates a moist and warm wound environment, is antiseptic, cleans the wound, with no sticking to the wound. Averts skin maceration and is skin-friendly.
LIGASANO® white significantly reduces the risk of wound creation as a result of poor blood circulation. Wound healing disorders due to poor blood circulation are reduced or removed, and infected wounds are cleaned, largely without the need for any further action. It stimulates granulation and epithelisation and the desired results usually occur surprisingly quickly and clearly.
LIGASANO® white is not an implant, and must therefore not remain permanently in wounds. After a maximum of 3 days contact with the wound the LIGASANO® white padding of the wound surface and/or padding inserted into the wound must be changed.
What is important to remember in all applications:
LIGASANO® must always be applied by the doctor or medically trained personnel.
What kind of products are available
LIGASANO® white is available in different sizes (e.g. sheets, rests for operating tables, compresses, wound strip), and depending on application is available in sterile or unsterile forms. Please be aware of the possible risks such as severe contaminations in case of on-site sterilisation. Please see the available sizes in the particular current product list.
How is it to store:
LIGASANO® white is highly flammable and sensitive to UV radiation. Therefore protect against fire, embers, heat, UV radiation and humidity/moisture. In its original packaging a confined protection exists against humidity and UV radiation by the special plastic film (it filters out a great part of the ultraviolet rays) we use. The storage is only permitted in the original packaging. LIGASANO® white may display a yellowish discolouration. This does not affect the quality.
Permissible storage conditions
for sterile products: +10°C to +30°C at 30-65% r.F.
for unsterile products: -20°C to +60°C
Disposal / Environmental relevance:
Apart from accredited quality (QM system for medical devices), LIGAMED® also documents environmental awareness by validation according to EC regulation (EMAS) and participation in „Umweltpakt Bayern“ (Bavarian Environmental Understanding). All LIGASANO® products are single-substance-materials made of polyurethane, consisting of approx. 97% air and can be disposed off with household waste. Disposal of the packaging is internationally regulated in different ways, in Germany via Reclay VfW GmbH.
The use of LIGASANO® white
1.1. Basic wound treatment:
1. for wound treatment:
- With LIGASANO® white you can clean, cover or fill wounds.
- By the special properties of its surface a mechanical stimulus is caused on the area of contact, favouring the blood flow, and hence stimulates at contaminated or infected wounds the normal body reaction “wound cleaning by secretion”. Moreover the transportation of substances should be stimulated hereby in the wound and so effects a promotion of granulation.
- LIGASANO® white is able to be combined with LIGASANO® green in some cases of application.
- A combination makes sense if e.g. a considerable quantity of exudate has to be subdued, which exceeds the absorption capacity of LIGASANO® white.
- The decision about the particular kind of application of LIGASANO® white is determined by medic or medically trained personnel and is adapted and appropriated in every single case.
LIGASANO® white is intended for once-only use and is usually applied directly onto or into the wound without any further steps and products (in particular no use of ointments or irrigation, etc.). Additional measures often negatively affect the potential result. Apply 1-2cm thick LIGASANO® white to skin-deep wounds, the edges overlapping the wound by 1-2cm. Deeper wounds, pocket-shaped wounds and hollow wounds should be completely padded out with LIGASANO® white. There must be overall reliable contact with the wound. To guarantee this, LIGASANO® white can be compressed by up to 50%.
1.2. Risks and Adverse Effects - Contraindications:
Padding thickness: Measuring from the wound base LIGASANO® white should be a total of at least 2cm thick. The thickness can also be formed from several layers, including the outer covering of the wound.
Padding-change frequency: 1x daily to 1x every 3 days, but in any case as soon as the first sign of secretion becomes visible on the outside of LIGASANO® white. Wounds which heavily suppurate during the cleaning phase should therefore also be changed several times daily.
Padding technique Adapt to fit each individual case. Ensure the wound is left uncovered for the shortest possible time to avoid it cooling down and to keep re-infection low.
Septicaemia: Usually no additional cleaning of the wound is necessary, even with infected wounds. However, in the case of septicaemia treat the wound additionally in the correct way.
Typical wound-cleaning sequence: With chronic wounds the wound-cleaning phase requires approx. 10-20 padding changes. The result is the smallest possible “clean“ wound, with low susceptibility to re-infection.
Sticking to wound: LIGASANO® white does not stick to the wound. If this is the case, the main fault lies in the fact that there is partially no contact with the wound. If this cause can be excluded, LIGASANO® white can be moistened on the side facing the wound to prevent it sticking.
- is in its sterile form qualified only for single use. The sterility of the sterile forms is ensured only at intact package.
- must not be used anymore after the expiration.
- is not allowed for reconditioning / re-sterilisation if you use it for wound treatment. (Cave: probably polluted or contaminated material with all known risks for patients.)
- must not remain in the wound or on the body in perpetuity. Recommendation: 1 – 3 days, depending on the indication.
- must not have any contact to the mucosa.
- must not have any direct contact to organs.
- applications in contact, connection or combination with additional preparations, drugs, solutions, ointments etc., are not checked by us.
- applications in combination with additional mechanical, electrical or electronical apparatus and aids are not checked by us.
- Because of its cell structure a vascularisation e.g. of granulation tissue into the material is possible. You can prevent this by a change in time of LIGASANO® white.
- During application and change of the dressing you have to avoid as much as possible a friction of wound, wound-ground or skin, for no resp. no additional lesions, which might cause.
- Especially at the application on or in hitherto passive wounds or on parts of the body, which are as yet badly supplied with blood, it can come to considerable pain sensations. This circumstance appears, if by the mechanical stimulus of the material the blood circulation is stimulated so far, that previously reduced or lapsed (and therefore unaccustomed) sensation of pain returns. But this is initially felt often for abnormal intense. Usually this sensation is regularised after some hours or not later than after a few days. If this effect is not desired, you should renounce this application.
- Too heavy pressure by initial tension of the material, extraneous cause or suction may lead to compression of vessels and therefore to pressure ulcers.
Consideration of risks:
LIGASANO® white is a very simple product, the effect of which results in its structure. It contains no agents and does not emit such either. The effect resp. the aspired effect is little complex - contrariwise quite easy and with general knowledge well comprehensible.
With the correct application of LIGASANO® white there are no known undesirable side effects, incompatibility or interactions with medicine. Typical and desirable is reddening of the skin in contact, initial “itching“, a more intense wound, return of sensitivity (in the case of wounds or also pain) as a result of stimulation of the blood circulation.
The Use of LIGASANO® white
2. For Pressure Relief + Hygiene:
- To obtain a good pressure relief by pressure distribution, you can cut LIGASANO® white to fit with a pair of scissors.
- There are no specific risks at the use of LIGASANO® white for pressure relief and hygiene without contact to skin if you follow the general rules for care and our special instructions.
2.1. Prevention of decubitus through active changing of the patient´s position:
the rapid drop in pressure tension from LIGASANO® white enables almost even distribution of the pressure from the surface padding and thus avoids the dreaded pressure points. LIGASANO® white can be simply cut to fit. This is how aids such as pulleys, wedges and shoes with heels etc. are created for changing patients’ positions, having been adapted by imaginative nursing staff. The mechanical stimulus of LIGASANO® white stimulates the peripheral blood supply where there is contact with the skin, and the patient’s residual pressure increases. Surplus sweat is absorbed, leaving normal skin moisture, and care of the skin is also associated with the mechanical stimulus. If LIGASANO® white is the appropriate thickness it does not form any folds, thus actively preventing a further risk of decubitus. Patients are always placed directly onto LIGASANO® white with no layer in between so that there is skin contact.
2.2. Prevention of arterial circulation disorders in the legs:
the 10cm wide LIGASANO® white bandage is wrapped around the leg without tension. Continue wrapping until it overlaps by one half or three quarters over the joint area. The mechanical stimulus of LIGASANO® white stimulates the blood circulation. A loose nylon stocking can be worn in addition to secure the bandage in place, but every kind of compression must be avoided.
2.3. Prevention of fungal infections and/or inflammation at skin-to-skin contact:
a wet and warm low-oxygen environment around the skin /skin-contact encourages the occurrence of fungal infections and inflammations of the skin. An intermediate layer of 1-2 cm of LIGASANO® white is extremely effective against this, being both preventive and therapeutic. If fungal infections do occur, an additional remedy can be applied thinly to the affected sections of skin, if necessary. Additional measures are not usually necessary in the case of inflammation. Typical application: Between toes and fingers or in folds of the stomach, under breasts, and for armpits and contractures.
2.4. Other applications:
due to the fact that LIGASANO® white combines the advantages of many other dressings and products and because it can be manipulated into almost any shape you like, new helpful application possibilities are continuously being discovered.
All information given is to the best of our knowledge by publishing this text, and based on many years of medical and nursing experience with LIGASANO®. We are interested in hearing about your practical experience with LIGASANO® and always welcome proposals, criticism, case studies, trials, or other information from practical experience.
If you recognise during the use of LIGASANO® consequences of the application being not mentioned here, or risks and assumed risks respectively, please notify us immediately.
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