Product Information

Device Description
Intended Use/Indications
Contraindications
Individualiztion of Treatment
Warnings
Adverse Reactions
Maintaining Device Effectiveness
Patient Counseling

Device Description

Laser-Seal is an occlusive dressing applied to the face in a gel form. In a matter of minutes, the self-setting silicone gel turns into a thin, semi-transparent membrane with adhesive qualities that supports a moist wound environment. Laser-Seal is non-reactive, non-resorbable and allows for the exchange of gases, such as oxygen and water vapor, through the dressing. Laser-Seal precisely adapts to the shape of the underlying facial structures, does not require tailoring, is easy to apply, and requires a minimal application time of 8-10 minutes for the entire face.

Intended Use/Indications

Prior to the application of Laser-Seal, the skin is thoroughly dried. Hair-bearing sites adjacent to laser-treated areas are protected with cholesterol cream, antibiotic ointment or Vaseline (TM). Care must be taken when using petroleum-based lubricants to avoid contact with the dressing, as they will inhibit the cure of the silicone. Each cartridge should be labeled with patient identification information and any remaining silicone may be used for touch-up or replacement of the original dressing. Occlusive dressings are known to reduce patient discomfort as well as decrease the intensity and duration of postoperative erythema.

Contraindications

Laser-Seal should not be used as a delayed dressing on potentially contaminated wounds, or on patients known to have silicone sensitivity. Application to the tarsal portion of the eyelids, hair-bearing skin, intraoral and intranasal regions should be avoided.

Individualization of Treatment

Using the applicator gun and the double barrel cartridge, Laser-Seal is evenly distributed in a step-by-step fashion. A tongue blade or other flat device aids in evenly distributing the silicone. Any irregularities are eliminated with a gloved fingertip lubricated with a water-soluble gel such as Surgilube(TM). If the red portions of the lips are treated with laser, they should be lubricated with a product of the physician's choice. Laser-Seal is not applied to the tarsal portion of the eyelids. The evenly distributed silicone should be allowed to cure while the patient refrains from conversation and facial movement. Thereafter, no specific care is necessary. By replacing the cap on the patient labeled cartridge, surplus Laser-Seal can be saved for later use if reapplication is deemed necessary. Removal and reapplication is only occasionally necessary around the perioral area.

Depending on the depth of the laser treatment, the patient's skin type and ability for epithelialization, the dressing is kept in place for 2-5 days. After the first 2 days, if any part of the dressing has separated, it may be trimmed. If a gentle attempt to elevate the silicone fails to separate the mask from the face, the mask should remain in place for a few more days. By the 3rd or 4th day, the perioral silicone loosens, which facilitates removal of the entire mask by segmental, gentle peeling. After mask removal, a moisturizer such as Aquaphor(TM) should be applied to avoid desiccation of the skin. Partial loosening of the mask is not always an indication for removal and/or reapplication of the silicone. A slightly loose mask will still serve the purpose of skin protection and retention of moisture.

Warnings

Laser-Seal should not be applied to the tarsal area of the eyelids or hair-bearing sites.

Prior to re-application, a dime-sized portion of silicone from the labeled cartridge should be discarded to ensure reapplication of fresh silicone. Re-application of any silicone material should be limited to the labeled cartridge for a specific patient or a new cartridge should be used.

Any indication of silicone sensitivity should be treated promptly by removal of the silicone mask and consultation with a physician.

Safety and effectiveness in pregnant women and children under the age of 10 have not been established.

Adverse Reactions

Use of Laser-Seal as a delayed dressing on potentially contaminated wounds should be avoided because of the higher risk of infection. Use of Laser-Seal on patients with known silicone sensitivity must be avoided because of the risk of systemic reaction. Any indication of infection will mandate removal of the silicone dressing and appropriate wound care. Intervention with systemic antibiotics may be necessary and should be done under the care of a physician.

Maintaining Device Effectiveness

After it is delivered to the skin, Laser-Seal remains workable for about 10-20 minutes. Room temperature and other variables may decrease or lengthen this time. While the dressing is in place, no additional care is usually necessary. There is an occasional need to trim the irregular borders of the silicone around the eyelids or the circumoral area. Rarely, the silicone loosens around the lower lip, necessitating removal and reapplication of the dressing.

Oral commissures should be periodically cleaned. If there is any dried secretions or drainage in the submental area, it may be cleaned off with sponges soaked in warm water.

Patient Counseling

During the silicone cure period, the patient should be instructed to avoid conversation and facial movement.

During the application process and silicone cure period, the patientís lips should be closed with jaws in occlusion.

Patients should be advised that reapplication might be required, commonly around the perioral area.

Patients should be advised that some drainage might be seen around the edges of the silicone mask. This drainage may be cleaned using wet sponges.

Patients should be informed that depending on individual differences, mask removal might occur between the 5th and 7th day following laser treatment. Patients should be alerted that any indications of silicone sensitivity, mask irritation, or infection should be immediately reported to their laser treatment specialist for appropriate follow-up care.

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