CLOZEX DWG-0086-02 Skin Closure Owner’s Manual

CLOZEX DWG-0086-02 Skin Closure 

Clozex wound closures are numbered  1 2 3 and are color coded: RED, WHITE and BLUE to indicate the sequence of liner removal.

CLOZEX® SKIN CLOSURE SIZES

Clozex Application Guidance

1. Select the device size(s) to match the incision shape and length. Multiple devices can be combined in series to achieve the length and geometric shape needed.
2. Closures may be overlapped to close angled or curved wounds.
3. Wound edges may be adjusted/straightened with forceps prior to applying Clozex.
4. Clean the skin 5-7cm around the incision using a sponge moistened with isopropyl alcohol or normal saline solution, taking care to remove exudates and excessive skin oils.
5. Dry the skin area prior to and during device application as may be needed throughout device application.
6. Do not lift and reapply any portion of the device; remove it completely and reapply a new device if needed.
7. Once applied, the top of the Clozex device may have exposed edges that could irritate overlying pendulous tissues (e.g. breast, thigh, abdomen, axilla, etc.). To assure patient comfort, suitable cover dressing should be used over Clozex in these areas.
8. Do not adhere any cover dressing directly onto the Clozex device as this could result in accidental removal of Clozex device.
9. Provide the Patients Care Instructions post surgery.

Clozex Indications for use:

1. The closure of low-medium tension lacerations and surgical incisions.
2. As an adjunct to suture closures for higher tensioned wounds.
3. For wound reinforcement after early suture or staple removal.

Contraindications:

1. Do not use Clozex where good adhesion cannot be obtained such as areas with excessive amount of wound fluids, skin oils, moisture or hair.
2. Do not use Clozex  on infected areas.
3. Risk are associated with the potential dislodgement of the device and allergic reaction to the adhesive.

Warning:

1. The development of postoperative edema may cause skin shearing, skin blistering or loss of adhesion to occurs.
2. As with all adhesive products applied to skin , removal can result in skin stripping
3. As with all adhesive products applied to skin, a small percentage of individuals may experience hypopigmentation or hyperpigmentation after removal.

Clozex® Step-By-Step Application

1. Remove LINERO {RED) to expose the adhesive on both clear pads of the device.
   Turn the device over with adhesive pads facing the skin. Pull skin closure device apart as needed to widen gap between adhesive pads.
   
2. Holding the LINERS 2 {WHITE), apply each clear adhesive pad to the skin 1-2mm from each side of the wound edge. Gently press to secure each half one at a time. APPLY PADS TO DRY SKIN ONLY.
   
3. Gently remove LINER 2 {WHITE) while holding the adhered pad to the skin and gently press the pad to secure it firmly to the skin. Repeat steps 2 and 3 to apply the second pad to the second wound edge.
   
4. Holding the pull tabs and LINERS 3 {BLUE) perpendicular to the wound, peel down LINER 3 {BLUE) on each side exposing the filament strap adhesive. Dry the tops of the adhesive pads if needed before closing.
   
5. Holding the clear pulling tabs in each hand, pull the wound edges closed uniformly all along the wound edges while gently lowering the straps.
   
6. When the skin edges are properly aligned, lower the filament straps down onto the secured adhesive pads.Press the filament straps to secure them on the adhesive pads.
   
7. To remove the pulling ends press each adhered filament strap next to the perforation and gently twist off the end.
   
8. Repeat for all straps on the other side.
   

CLOZEX MEDICAL, INC. J I24 GROVE STREET I FRANKLIN, MA 020381 ‘f. +I 781-237-1673 I
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Documents / Resources

CLOZEX DWG-0086-02 Skin Closure [pdf] Owner's Manual DWG-0086-02 Skin Closure, DWG-0086-02, Skin Closure, Closure

References

• User Manual