Instructions For Use
SUTUREGARD® Intraoperative Skin Relaxation Device is comprised of two components: (1) a sterile deformable suture bridge with soft elastomer covering and (2) a sterile circular suture guide with central aperture to collect suture ends.
The SUTUREGARD® Intraoperative Skin Relaxation Device is indicated for intraoperative support and/or skin stress-relaxation of non-contaminated, acute surgical wounds of LESS THAN 3.0 cm width.
(i) Do not reuse. This product is intended for single use, one patient only. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. (ii) Do not re-sterilize the bridge or suture guide. (iii) Discard open, unused devices. (iv) Do not use if package is open, torn or damaged.
Excessive force applied for prolonged durations may lead to pressure injury. The amount of force and duration of application that are tolerable will vary with patients and wound location. If the method is used beyond a given wound’s tolerability of pressure and/or duration, pressure injury may result. For those reasons, we recommend minimizing the duration and tension as much as possible. In clinical trials, most stress-relaxation occurs within the first 30 minutes of application. (View Publications).
Possible Adverse Effects
While the device has been designed to absorb the force of a high-tension suture, excessive force applied for prolonged durations may lead to pressure injury. Pressure injury may involve damage to the epidermis, dermis, fat or underlying structures such as nerve, muscle or bone.
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Suggested Method of SUTUREGARD® Intraoperative Skin Relaxation
The SUTUREGARD® Intraoperative Skin Relaxation Device is indicated for intraoperative support and/or skin stress-relaxation of acute, non-contaminated surgical wounds of LESS THAN 3.0 cm width. The SUTUREGARD® Intraoperative Skin Relaxation Device should be selected for use depending upon patient condition, surgical experience, surgical technique, condition of peri-wound skin, wound size and wound tension. The device must be removed within 5 hours of application. In most instances, the device will be removed within 60 minutes of initial placement.
Step 1: Suture
It is recommended to use a large caliber (e.g. USP 2-0 or larger) nonabsorbable (e.g. nylon) suture with appropriate needle to puncture skin. The suture is placed with large bite size (e.g. 10mm) so that the suture passes through the full thickness of skin on each side of the wound. We STRONGLY recommend removal of the surgical needle at this point.
Step 2: Thread
Insert one suture end into each slot of the SUTUREGARD® bridge with the centrally elevated eversion bump pointing away from the skin (as shown). Optionally, the suture ends may be inserted through the SUTUREGARD® washer (as shown).
Step 3: Stretch
Apply tension to suture ends and secure with a clamp (as illustrated) or knot. If a clamp is used, it can be un-clamped to allow tension re-adjustment every 5-10 minutes (or at discretion of surgeon) and re-clamped.
CAUTION: Excessive suture tension may impart pressures on skin that may lead to pressure injury. The ability of a wound to tolerate pressure is dependent on many variables and requires surgeon judgement on a case-by-case basis.
Step 4: Close
Close sides of wound with suture and/or staples.
REMOVE the SUTUREGARD® bridge and washer from the wound. DISCARD the SUTUREGARD® bridge and washer immediately after removal.
The central portion of the wound can be closed or allowed to heal second intent as per surgeon preference.
How To Open a Sterile Package
Remove the SUTUREGARD Device from its package in an aseptic environment using talc-free gloved hands.
- Peel open the package
- Invert package over sterile field, allowing the bridge and suture guide (washer) to gently fall into sterile field.
- Discard packaging
Frequently Asked Questions
How much tension can be applied to the wound?
In clinical trials of SUTUREGARD® device-assisted stress-relaxation, up to 25 Newtons (2.5 kg) of force has been applied to the suture. With such tensions, adverse events are uncommon (less than 10%) and include superficial pressure injury. In most cases, such injury heals within several weeks of routine wound care.
How do I prepare the wound for stress-relaxation?
The wound should be prepared with a standard surgical preparation at the start of the procedure. Prior to applying tension to the suture, the skin around the wound should be clean and dry.
How do I care for the wound after surgery?
The SUTUREGARD® bridge and washer MUST be removed and discarded prior to the final wound closure and application of dressings. Wound care and support (e.g. staple, suture) removal can be according to surgeon preference.
What kind of clamp do you recommend to secure the sutures?
We typically use the lightest available hemostat. Use of a heavier hemostat or needle driver will put asymmetrical pressure on the SUTUREGARD® Device, increasing the risk of pressure injury.
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