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This product tutorial instructs the user for basic use of the TopClosure®  Tension Relief System (TRS) . Before using the TopClosure® TRS read the Instructions For Use carefully. This is not a reference for surgical techniques. 

Contraindications:

  • Non-invasive application of TopClosure® is contraindicated for patients with very thin, delicate sensitive skin (in these patients, anchoring with staples or sutures is indicated exclusively with extra caution to the stress applied when stretching the skin). If the skin surrounding the treated site is delicate, thin or fragile, re-evaluate the need for TopClosure® application. If absolutely needed, apply the TopClosure® at a slightly distant location away from the problematic area.
  • This device is not intended for use with the applied adhesive surface in patients with a known sensitivity to adhesives. Other methods of application should be considered.
  • Attachment using staples or KW should not be used when it is impossible to maintain a 7mm distance between stapled skin surface and underlying vital structures such as blood vessels, major nerves, internal organs, bones and connective tissue such as tendons and ligaments.
  • Extra caution should be taken when applying the TopClosure® in the following cases:

o   When non-viable or atrophic tissue is present at or near the wound edges.
o   When the patient has received localized radiation treatment at the wound site.
o   When the patient is receiving chemotherapy.

  • Special consideration should be made for application of TopClosure® in areas of repetitive motion as in areas adjacent to joints. Application of TopClosure® for these areas may be considered for each individual patient, and may require limb and joint immobilization.
  • The TopClosure® application is contraindicated when the designated adherent area is infected.
  • The TopClosure® should not be applied for stretching of heavily scarred tissue, with minimal laxity of the skin.
  • Special caution should be taken when stretching circular organs (e.g. limbs) with the TopClosure®, to avoid inducing compartment syndrome, inflicted by excessive stretching of the skin. If compartment syndrome is suspected, immediately release the tension by releasing the straps and/or the sutures. 

As an invasive wound closing aid, the TopClosure® is designed to bring the skin margins together so that they may be safely sutured or stapled, using conventional methods. By applying a controlled amount of tension evenly along the wound margins, the TopClosure® uses the visco-elastic properties of skin to cause it to stretch and extend while minimizing its tendency to recoil. This process, known as "Mechanical Creep", does not impair the immediate or long-term viability of skin. The amount of tension applied by the device is controlled by the surgeon. As the skin expands and tension is reduced, additional tension can be applied incrementally in repeated cycles until the skin margins are brought into close apposition for suturing or skin grafting. The device is then removed.
Applying the TopClosure® TRS Non-Invasive
  • Prepare for excision of skin tumor, thoroughly clean and dry the skin.
  • Adjust the attachment plates to fit the skin’s curvature by bending the plate.
  • Peel the cover of the adhesive tape underneath the plate.
  • Firmly attach the plate 1.5-2 cm away from the margin of excision.
  • Prepare the medical adhesive tape and apply the tape to secure the attachment plate to the skin.
  • Fix the medical adhesive tape to the skin and peel the covering film.
  • Plan the placement of the contra-lateral attachment plate to align with the vector of pull.
  • Repeat all stages for the second plate.
  • Gently pull the lock/release mechanism and insert the approximation strap.
  • Keep the plate attached to the skin at all times and pull the strap all the way out.
  • Secure the plate to the skin by pressing with the little finger and insert the strap through the lock/release mechanism and pull towards the remote plate.
  • Keep both plates attached to the skin and approximate the margins of excision by pushing both plates towards each other.
  • In case of excessive pull and collapse of the LR/M and the approximation strap wings, re-insert the strap and pull gradually in order to maintain functionality of the system and avoid repeated failure of the approximation strap wings. 
  • Lock the strap by pressing down the lock/release mechanism.
  • To release the strap lift up the knob and take the strap out from the other side by pushing it out.
  • Keep the plate down and pull the strap all the way out.
Applying the TopClosure® TRS non-invasive with Extra Liquid Adhesive
  • Prepare for excision of skin tumor, thoroughly clean and dry the skin.
  • Crack the liquid adhesive ampoule and apply to the skin.
  • Allow the liquid adhesive to dry for 20-30 seconds.
  • Adjust the attachment plates to fit the skin’s curvature by bending the plate.
  • Peel the cover of the adhesive tape underneath the plate.
  • Firmly attach the plate 1.5-2 cm away from the margin of excision.
  • Prepare the medical adhesive tape and apply the tape to secure the attachment plate to the skin.
  • Fix the medical adhesive tape to the skin and peel the covering film.
  • Plan the placement of the contra-lateral attachment plate to align with the vector of pull.
  • Repeat all stages for the second plate.
  • Gently pull the lock/release mechanism and insert the approximation strap.
  • Keep the plate attached to the skin at all times and pull the strap all the way out.
  • Secure the plate to the skin by pressing with the little finger and insert the strap through the lock/release mechanism and pull towards the remote plate.
  • Keep both plates attached to the skin and approximate the margins of excision by pushing both plates towards each other.
  • Lock the strap by pressing down the lock/release mechanism.
  • To release the strap lift up the knob and take the strap out from the other side by pushing it out.
  • Keep the plate down and pull the strap all the way out.
Applying the TopClosure® TRS for Stress-Relaxation
  • Clean and dry the skin surface prior to application of the attachment plates.
  • Peel off the adhesive tape on the back of the attachment plate.
  • Apply the self-adhesive attachment  plate to the wound,  1.5-2 cm from the wound edge.
  • Use staples to further secure the attachment plates to the skin. Please note the size of staples 6.5 mm x 4.7 mm to be compatible with TopClosure®.
  • Apply staples alternating from proximal to distal.
  • Apply the 2nd attachment plate to the opposite side of the wound, 1.5-2mm from the wound's edge, in line with the vector of pull.
  • Secure the attachment plate to the skin using staples.
  • Choose the tension sutures.
  • Apply tension sutures through the designated oval holes in the attachment plate, grip the deep soft tissue layers on both sides of the wound and add a sleeve to the suture to protect the outer layer.
  • Apply repeated Stress-Relaxation to the skin with tension sutures, pull for 30 seconds and relax for 1 minute.
  • Ty the tension sutures in stages.
  • Apply staples to adjust skin approximation.
  • Add the approximation straps for reduction of wound tension for final wound closure.
  • On open wounds sterile gauze must be placed under the approximation strap and if closure of wound needs to be delayed due to infection, vacuum system can be additionally applied.
© Copyright 2010. IVT Medical Ltd. | Phone: 972-9-7463737 | Fax: 972-9-7604506 | Mail: info@topclosure.com 3D by AlonSaranga | developed & designed by e-way