Instructions for Use

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Description

NanodermTM, a new bioengineered product, is a microfiber based film of pure cellulose. Its average thickness is 0.05 mm, and its selective permeability allows for the passage of water vapor but inhibits the passage of water and microorganisms. NanodermTM manufactured in Canada was developed using state-of-the-art technology and it is especially indicated for the treatment of lesions where there is a loss of skin. Since NanodermTM is manufactured using a biologically inert substance, it does not cause any type of rejection and adheres naturally to the open wound (without the need for any type of adhesive). It forms a tight seal around the wound, thus allowing for a quick renewal of the epithelium and minimizing hydroelectrolytic losses. NanodermTM eliminates the conditions for bacterial proliferation and significantly abates pain symptoms. It is semi-transparent allowing for an easy check of progress of healing, without having to remove the wound dressing. In summary, NanodermTM complies with most of the ideal requirements for a temporary skin substitute.

Clinical Advantages

NanodermTM advantages include:

  • Easy application and removal
  • Visual healing check as it is semi-transparent
  • Fewer bandage changes – often only one application
  • Reduces conditions for bacterial contamination and proliferation
  • Physiological tissue protection
  • Reduces hydroelectrolytic losses
  • Non-toxic and non-pyrogenic
  • Hypoallergenic and sterile
  • No special storage conditions required (normal shelf-life: 2 years)

For the patient, there is reduced handling, less pain, less stress, more comfort, increased hygiene, and earlier mobility. For the clinician, the process is time-saving. In some cases, patients may transition earlier to outpatient care as compared to conventional therapy.

Main Uses

NanodermTM is indicated in case of lesions where there is a loss of epithelium, whether they are serious or superficial, acute or chronic, such as:

  • Second degree burns
  • Dermabrasions
  • Donor areas of graft tissue
  • Ulcerations of varied etiology
  • Injuries caused by incisions, contusions or a combination of both
  • Decubitus ulcers
  • Diabetic foot ulcers.

Application Method I

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In case of acute superficial lesions such as:

  • Superficial burns ·     Dermabrasion     ·     Donor areas of graft tissue

Step-by-step application procedure is as follows:

  1. Establish aseptic conditions.
  2. If necessary, administer analgesic to patient.
  3. Have available NanodermTM, anatomic pincers, dry gauze, physiological saline, and tincture of iodine.
  4. Cleanse the wound.
  5. Debride as required.
  6. Wash the affected area using physiological saline.
  7. Remove NanodermTM from its sterilized package (A).
  8. Take a piece of NanodermTM close to the lesion to estimate the area to be covered (B), assuming that the film should exceed the edges of the wound by 1 cm. If necessary, use two or more pieces of film. They should overlap each other by 1 cm (Note: NanodermTM may be prehydrated with sterile water or normal saline, for easier application).
  9. Apply NanodermTM delicately over the lesion and surrounding skin to achieve perfect adhesion (C). Using moist gauze, dab gently over the film, removing excess air bubbles and fluid. The moist NanodermTM will adhere to the lesion and surrounding skin as it dries. Carefully trim excess Nanoderm (D).

The patient should be advised that a stinging feeling may ensue, as a result of NanodermTM settling over the exposed nerve ends. After a few minutes the stinging feeling will disappear.

After the application of NanodermTM has been concluded, the physician will have two choices: to leave the area and film exposed or to cover them with bandages. The first procedure has the advantage of accelerating the drying up of the exudation and it is recommended under the following conditions:

  • The lesion does not involve joints
  • The patient will remain in an area where hygienic conditions are good
  • The patient's age or state of mind will not impede resting the affected area.

If the former conditions are not met or if the patient does not tolerate the lesion and film to be exposed, bandages should be used to cover the area. In cases where the lesion involves joints, the area should be immobilized as much as practical for at least the first five days, until a protective scab is formed. The patient should be positioned in such a way as to allow for the affected limb to be elevated and if necessary, an analgesic may be prescribed.

Application Method II

In cases of grave and chronic lesions, such as:

  • Varicose ulcers ·     Ulcers of diabetic etiology

Step-by-step applications procedures are as follows:

  1. Collect material for bacterial culture, if required.
  2. Have available the following materials, in perfect conditions of asepsis: anatomic pincers, gauze, physiological saline, scissors, soft sponge, gloves, germicide solution, bandages and NanodermTM.
  3. Wearing gloves clean the ulcerated area and surrounding skin.
  4. Remove necrotic tissue.
  5. Rinse the area with physiological saline to eliminate traces of germicide solution.
  6. Take a piece of NanodermTM close to the lesion to estimate the area to be covered, assuming that the film should exceed the edges of the wound by 1 cm (A, B).
  7. Apply the film over the ulcerated area and surrounding skin and exert light pressure on it using moist gauze, so maximum adhesion can be achieved (C).
  8. Remove excess fluid and air bubbles found in between the wound and the film. Carefully trim excess NanodermTM (D).
  9. Place dry gauze over the affected area and then bandage it.
  10. If necessary, prescribe an analgesic and rest.

An assessment should be conducted after 48 hours and the following conditions may be found: good adhesion between the film and the ulcer, a fine film of milky-yellowish fluid under NanodermTM with brownish borders. If there is an excess of secretion, the film will appear swollen and the patient will experience pain. In this case, the secretion could be drained through the lower edge of the film.

There is the option of changing the film, which can be easily accomplished after making it wet. The aforementioned procedures should be followed in detail. If there is an infection, it will be revealed by a large quantity of secretion, fetid odour, edema, hyperemia and pain. Under these conditions, the film must be changed and the results of the bacterial culture should be taken into account to decide among topical or systemic antibiotics. Topical antibiotics offer the advantage of being in contact with the affected area for a longer time.

During the course of the infection the film should be changed every 48 hours, until the signs of infection disappear. After that, the film should be changed twice a week and finally every fortnight. Bear in mind that ulcers in most cases are infected and that a remission of the infection process will be marked by a decrease of secretion and phlogistic signs as well as the appearance of a brownish crust over the affected area.

Application Method III

In cases of decubitus ulcers:

  • On recently developed ulcers, when only the epidermis has experienced ischemia, NanodermTM should be applied exactly as indicated for acute superficial lesions. Normally only one application is required.
  • In the case of extensive and deep ulcers, the adhesion between the affected tissue and NanodermTM may prove difficult. Its use should be subject to medical opinion.

General Procedures

First assessment (within 24 hours)

In most situations expect the following: the film adheres to the exudation already dehydrated and formation of the protective scab is underway. Slight pain or a stinging sensation may or may not be present. The patient tolerates gentle palpation over the NanodermTM film without feeling pain. There might be some signs of edema and hyperemia around the wound. The film is smooth and glossy over gelatinous exudation with a limpid yellow coloration. Given the former conditions there is no need for a change of NanodermTM film. The analgesic may be suspended and rest may be partial rather than total.

Given that the film loses elasticity when dry, tears may occur, in which case the patient should be given a new application of NanodermTM to avoid contamination. New assessments should be conducted every 3 days, initially. The following conditions should be carefully monitored:

  • An excess production of exudation, forming sacs under the film. In that case the secretion should be drained, by lifting the lower edge of NanodermTM without need of changing the film. This procedure should be followed as often as necessary.
  • In cases where excess secretion has caused the film to shift exposing the affected area, NanodermTM must be removed and the area cleansed with physiological saline. New NanodermTM should then be applied.
  • In the above situation, the next assessment should be made within 24 hours. If a milky-yellowish secretion is found on the film, a sample should be collected for a bacterial culture. While the bacterial culture is in progress, symptoms of infection may occur, such as: excessive pain under palpation, edema, hyperemia and an increase in secretion with changed coloration. If the results of the bacterial culture are negative, there will be no need to substitute the film and the patient may be kept under observation.

In the case where an infection occurs, the following procedure should be observed:

  • If the secretion is found covering the entire film, it should be promptly changed. The affected area should be then cleansed under aseptic conditions and a new film should be applied (with a possible use of topical antibiotics).
  • If the infection is localized, the film covering the infected area should be trimmed and removed. The wound should be cleansed using the necessary precautions and a new section of NanodermTM should be applied. There is no need to change the whole film once the newly applied film section halts the spread of the infection to the surrounding areas.

Once the protective scab is formed over the wound, the patient may be permitted to take short showers. Please note that NanodermTM, once wet, acquires a whitish hue. The area must be dried up using soft and absorbent tissue and light strokes. A heating lamp or hair dryer may also be used, but only until the scab becomes dry. Avoid contact with clothing and bed linen. The patient may be upgraded from total rest to partial rest and physiotherapy may start.

On day 7 (± 2 days), the portion of film in contact with the scab starts to fragment, exposing pink, glossy and smooth tissue. This situation occurs from the outer edges to the centre of the lesion.

When this point is reached, no interference or manipulation of the affected area is recommended. An early removal of NanodermTM fragments may result in untimely exposure of the area in process of healing, thus risking a relapse.

The complete fall of the scab and NanodermTM takes about two days. Some patients may experience discomfort and itching because of excessive dryness of the protective crust. In those cases, moisturizing cream may be applied to the crust.

Side Effects

There are no known side effects related to the use of NanodermTM.

Adverse Reactions

The only observed reaction in very few cases is maceration of the healthy tissue surrounding the lesion. In that case, the application of NanodermTM must be suspended.