CE 0481 (appendix II, class IIb, acc. to regulation 4)
What is LIGASANO® green and what is it used for:
LIGASANO® green is an elastic, expanded polyurethane (PUR), which is almost always pervious to air and liquids (e.g. water) - imagine a three-dimensional sieve. It has a coarse texture and rough surface.
LIGASANO® green is used for wound treatment and care, if a strength and elastic material with high permeability to air and fluid is required.
- Sterile on or in wounds, if the dermis is cut through and may only be healed by secondary wound healing.
Sterile or unsterile for nursing care and concomittant wound treatment without direct contact to wound, but with direct contact to skin.
- Sterile or unsterile for pressure relief and hygiene without direct contact with the skin.
What is important to remember in all applications:
The surface of LIGASANO® green is relatively coarse. At the use in wounds or on skin may develop lesions, especially by friction.
It must always be applied by medic or medically trained personnel.
What size is available?
LIGASANO® green 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 see the available forms in the particular current product list.
How is it to store:
LIGASANO® green 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.
Permissible storage conditions for sterile products: +10°C to +30°C at 30-65% r. h.
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® green
1. For Wound Treatment and Contact with Skin:
Risks and Adverse Effects - Contraindications
- With LIGASANO® green you can clean, cover or fill wounds. It countervails a collapse of wounds by effect of external pressure or suction, e.g. during an active wound drainage.
- By the special properites 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”. Likewise the transportation ought to stimulate thereby in the wound and so effects a promotion of granulation. This active principle is known and approved since decades by LIGASANO® white.
- By the described open structure of LIGASANO® green wound irrigations are possible in spite of the filled wound.
- A drainage of exudate, irrigation etc., following the gravidation down out of the wound is made possible.
- LIGASANO® green ia able to be combined with LIGASANO® white in some cases of application.
- A combination makes sense if e.g. a considerable quantity of exudate has to be subdued, that rises above the absorption capacity of LIGASANO® white.
- At urinary incontinence ought to be afford an urinary outflow within the usual incontinent care with a common underlay or trousers, down, away from the skin, so that the skin is protected against this duresis.
- The decission about the particular kind of application of LIGASANO® green is determined by medic or medically trained personnel personnel and is adapted and appropriated in every single case.
- Is in its sterile form qualified only for single use. The sterility of the sterile forms is ensured only at intact package.
- Is not allowed to use anymore after the expiration date.
- Is not allowed for reconditioning / re-sterilisation if you use it for wound treatment.
- Is not allowed to remain in the wound or at the body in perpetuity. Recommendation: 1 – 4 days, depending on the indication.n.
- Is not allowed to have any contact to the mucosa.
- Is not allowed to have any direct contact to organs.
- Because of the coarse surface the medic have to decide in every single case, whether contact to the skin or to the wound is allowed.
- 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® green.
- During application and change of the dressing you have to avoid 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 circumstand 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.
- In the case of an “open wound care” without additional cover you have to take into consideration that there exists barely protection against the ambient atmoshpere.
- 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® green is a very simple product, whose effect results from its structure. It contains no agents and doesn´t emit such either. The effect resp. the aspired effect is little complex - contrariwise quite easy and with general knowledge well comprehensible.
At intended use the risks are marginal. A mechanical overstraining in the contact area of wound or skin is well predictable with the naked eye, and due to the anyway required medical care, the preparation may removed in time, if necessary, before any injury occurs. The effect is pure physical and stops virtually promptly after removal of the preparation.
The inavoidable residual risks are marginal compared to clinical advantage ans seem acceptable.
2. The Use for Pressure Relief + Hygiene without Contact to Skin:
LIGASANO® green has cushion qualities, as known from elastic foams, but without their property of thermal insulation, which is unfavourable in nursing care.
The special properties of LIGASANO® green mean that parts of the body can breathe, where dampness or suppuration would otherwise accumulate as a result of contact with other objects (e.g. flat bed surfaces, seats or back-rests etc.). As a result of gravity, large amounts of fluid can run downwards, and dampness (e.g. sweat) can evaporate. Skin maceration can be effectively prevented with this product.
- At this application of LIGASANO® green contact with the skin is avoided, because the rough surface of the material is mostly felt as unpleasant and perturbing, and for preventing lesions of the skin, which could effect by friction.
In addition, without any heat insulating layer, in normal temperated ambiance, it can come to hypothermia at the affected parts of the body. For an intermediate layer between skin and LIGASANO® green are exemplary suitable: stockings, clothing, bed sheet and especially a layer of LIGASANO® white with a thickness of 0.5 or 1 cm. It is important, that the intermediate layer is likewise permeable to air.
- To obtain a good pressure relief by pressure distribution, you can cut LIGASANO® green to fit with a pair of scissors.
- For the application without contact to skin you can use LIGASANO® green often for weeks. Soiled material is washable up to 90°C without suffering much under this procedure. Drying is unnecessary in most cases, because the material is after the spin cycle or the spinning by hand almost already dry. For this use the reconditioning by sterilisation with steam, up to 20 min. at 134°C (we recommend 4 minutes) is allowed. Please be aware of the possible risks such as severe contaminations in case of on-site sterilisation.
There are no specific risks at the use of LIGASANO® green for pressure relief and hygiene without contact to skin, if you follow the general rules for care and our special instructions.
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.
Original Leaflet for Download