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FAQs - ​Medical Use

Common Questions from Physicians

How do the Microstaples actually work?

After entering the skin, the microMend PRO’s Microstaples anchor to the underlying tissue and keep the wound closed. The Microstaples are at a slight angle to the skin surface, which helps prevent microMend PRO from pulling off the skin from movement or pressure due to fluid in underlying tissues.

What is the length of the microMend PRO device Microstaple?

The total length of the microMend PRO Microstaple is 1.5 mm. The Microstaples enter the skin at an angle, which results in an actual vertical depth of approximately 1 mm.


 

General Questions

What are the indications for use of microMend PRO?

  • microMend PRO is a primary skin closure device used to close surgical incisions, port sites, lacerations, and skin tears. It can be applied with or without sutures or staples to close superficial wounds that are under minimal tension. microMend PRO should be used as an adjunct to close the skin layer after suture or staple closure of underlying tissue in high-tension wounds or those that extend beneath the upper dermis. It is also indicated for incision reinforcement for wounds after early suture or staple removal.

In what kinds of wounds can microMend PRO be used?

  • Location: has the capability to be used to close most wounds. It comes in a range of sizes that allow closing nearly the broad range of wounds encountered in clinical practice.

  • Depth: can be used alone to close wounds that extend through the upper dermis. For deeper dermal or subcutaneous wounds, subcutaneous sutures/staples should be combined with microMend PRO closure on the skin surface.

  • Length: designed to close wounds of any length. Multiple devices are required to close longer wounds.

  • Wound type: can be used to close lacerations, skin tears, surgical incisions, and port sites.

  • Flexible areas: able to be used over flexible surfaces or those associated with skin movement such as joints.

  • Skin surfaces: microMend can be used on convex or concave surfaces as well as those that are variegated.

  • Wound shape: ideally suited for closing linear wounds, but can also be used to close curved wounds. Additionally, it can be used to close jagged or irregular wounds.

Why does microMend PRO achieve superior cosmetic results?

  • Microstaples do not cause tissue damage that leads to inflammation and scarring.

  • Microstaples are closely spaced eliminating wound gaps that scar.
  • Cantilever springs reduce tension along the wound that stimulates fibroblasts that cause scarring.
  • Microstaples are fixed and uniformly spaced eliminating inconsistent spacing that occurs with placing sutures and staples.

Is the material used hypoallergenic or latex-free?

  • microMend PRO contains Microstaples, which are made out of medical-grade stainless steel (the same material used in medical staples) and adhesive tape. It is hypoallergenic and does not contain natural rubber latex.​

What evidence do you have to support the use of microMend PRO on patients?

  • ​KitoTech Medical has conducted clinical studies that have shown outstanding clinical results using microMend to close wounds in a broad range of clinical specialties including surgery, dermatology, and emergency medicine (see Clinical Studies)​. 
  • Case studies have been conducted in several other specialties, including plastics, orthopedics, obstetrics, vascular surgery, and wound care.  Physicians have reported high levels of satisfaction with microMend and excellent results. 

Why should I use microMend PRO when I am happy with using staples or sutures?

  • Designed to replace sutures and staples for subcuticular closure of wounds. In healed wounds, it achieves equal tensile strength to sutures.

  • Demonstrated superior wound closure outcomes including cosmetic results compared to sutures in clinical studies.

  • Painless making it ideal for children and patients with needle phobia.

  • Applied like a bandage making it much quicker and easier to use than sutures and staples.

  • Time saving for the provider creates faster wound closure procedures. Studies have demonstrated that microMend PRO is 7 times faster in closing wounds than sutures.

  • Wound closure can easily be performed by ancillary personnel, such as physician assistants, nurse practitioners, nurses, and nursing assistants.

  • No need for suture tray, anesthetic, device removal kit (patient can remove), and return clinic visit for device removal.

  • Eliminates the need for additional superficial wound closure products such as Steri-Strips.

What are wounds where the use of microMend PRO should be avoided?

  • Infected wounds

  • Areas of high-tension

  • Areas where attachment of microMend PRO to the skin cannot be obtained, due to the presence of hair, exudate, blood, oily skin, excess moisture, or certain dermatologic conditions (e.g., psoriatic lesions, eczema).

  • Persons with a known allergy to skin adhesives should not use the device.

What is the difference between microMend PRO and bandages, such as Steri-Strips and butterfly closures?

  • microMend PRO has tiny skin gripping Microstaples which penetrate into the dermis making it possible to oppose and close dermal wounds. Bandages only contain adhesive and are not designed to close serious skin wounds. microMend PRO has stronger holding power provided by Microstaples, which also enables the device to stay in place over the healing continuum. In contrast, bandages are prone to creep and ultimately fail as the adhesive loses strength over time. This can lead to the re-opening of the wound.

How does microMend PRO compare to tissue adhesive?

  • Tissue adhesive requires more time to use (30 seconds to 2 minutes compared to only seconds with microMend PRO). There is an increased risk of wound dehiscence, especially if excess moisture is present. Once wounds are closed using tissue adhesives, the skin cannot be repositioned if closure is suboptimal. microMend PRO can be easily removed and replaced with another microMend PRO if adequate closure is not achieved. If tissue adhesive enters the wound, it can lead to significant irritation/inflammation.

Skin Closure Procedure & Post-Procedure Care

How long a wound can a single microMend PRO device close?

  • microMend PRO comes in a variety of sizes, including Small, Medium, Large, and Wide, and can close wounds of different lengths ranging from 0.75 cm to 4 cm depending on the size of the device. Additional microMend PRO devices need to be applied to close longer wounds. There is no limit to the total length of wounds that can be closed with multiple devices.

Do you need any bandages, such as Steri-Strips or butterfly closures to hold the wound closed in addition to microMend PRO?

  • No.

Can a microMend PRO device be reapplied if its placement is suboptimal?

  • No, the used microMend PRO should be removed and discarded, and replaced with a new microMend PRO device.

Is there any pain or discomfort associated microMend PRO application or removal?

  • Minimal to no discomfort with application and/or removal of microMend PRO. Local or topical anesthesia is not required for application.

Can skin preps such as antimicrobial solutions, other creams or ointments be applied to the wound site prior to use of microMend PRO?

  • No, microMend PRO should be applied only to clean, dry skin. After microMend PRO is applied, solutions, creams, and ointments are permitted only if recommended by your healthcare provider.

Should the wound be covered?

  • The wound must be covered for the entire duration in which microMend PRO is attached to the skin. If this is not done, there is a risk of the device detaching from the skin.

  • Ideally, a non-stick dressing such as gauze should be used to cover.

  • Never place adhesive tape or adhesive areas of a cover dressing directly over microMend PRO. It creates a risk of loosening or pulling the device off when the dressing is removed or changed. If it is used, the cover must remain in place until microMend PRO is removed

What precautions need to be taken to prevent microMend PRO from coming off of the skin?

  • Patient may take showers, but should minimize exposure of the wound to water.
  • The microMend PRO site and surrounding area should never come into direct contact with shower spray.
  • After showering, gently pat the wound area until dry.
  • Do not scrub, rub or soak the wound area and/or microMend PRO devices.
  • Do not immerse wound underwater (baths and swimming).
  • Avoid activities that may produce heavy perspiration.
  • Avoid wearing tight clothing over the wound area. Gently remove clothing over the wound area.

Can creams, ointments, and solutions be applied to microMend PRO or the wound?

  • Use of creams and other products that contain moisture is a decision for the healthcare provider; it is recommended that they be avoided unless absolutely necessary. Patients should not apply any products at the wound site without approval from their provider.

What is the effect of wound exudate or drainage on the attachment of microMend PRO to the skin?

  • The surfaces to which microMend PRO is applied should be clean and COMPLETELY DRY prior to application.
  • microMend PRO is designed to adhere to dry skin, and to allow drainage of exudate through the device without compromising its integrity after secure attachment to the skin is obtained during application.
  • In case of fluid accumulation beneath a microMend PRO device, microMend PRO can remain in place unless any detachment of the device is observed. In this case, it should be removed and replaced with a new device after drying the wound area.
  • Absorptive dressings (such as gauze) should be changed as needed so that microMend PRO is not in contact with the saturated dressing material for prolonged periods of time. Cover dressings that absorb and lock in exudate are recommended. Adhesive in dressings or bandages should not come in contact with the device.

What are possible outcomes that the patient may notice during the wearing of microMend PRO?

  • Slight redness, itching, or pain may occur in the area where microMend PRO is applied.
  • Bleeding may occur when microMend PRO is first applied to the skin and while wearing the device. It also occurs upon device removal. Simply placing pressure over the area with a sterile gauze or other material should eliminate bleeding. If it does not, the patient should contact their healthcare provider.
  • Consult the IFU package insert for a full list of possible outcomes.

What kind of wear time can be expected with microMend PRO?

  • Wear time of up to 2 weeks is possible, but not necessary in most cases. In general, wear time to keep the wound closed and allow healing is similar to that with sutures or staples. The patient should wear microMend PRO for the entire time frame recommended by their healthcare provider. However, wear time varies depending on the care of the skin closure, location of the incision and patient skin type.

What problems require action on the part of the patient?

  • If there is significant discomfort or if the wound area becomes significantly reddened, excessively warm to touch, severely painful, or there is drainage, the patient should consult their healthcare provider. This may be a sign of an infection.
  • If the edges of microMend PRO lift off the skin surface and/or the device will not reattach, trim the edge back to where the adhesive backing holds. Doing this may prevent loss of the device due to catching on clothing or other objects.
  • If microMend PRO detaches from the wound site earlier than the number of days recommended, the patient should contact their healthcare provider.
  • If microMend PRO remains in place beyond the recommended treatment time or more than 14 days, the patient should seek the advice of their healthcare provider.

What will the wound site(s) look like after removal of microMend PRO?

  • microMend PRO’s Microstaples produce tiny puncture wounds in the skin. They are much smaller than those that occur with sutures or staples. Some redness may also be noticed where the microMend PRO devices were applied to the skin. These tiny puncture wounds and redness should resolve in a few days to weeks after the device is removed. If they do not, the patient should contact their healthcare provider.
  • Slight bleeding from the wound site may occur at the puncture sites. Applying pressure using sterile gauze or other material should stop the bleeding. If it does not, the patient should contact their healthcare provider.