Common Questions from Physicians

How do the Microstaples actually work?

After entering the skin, the microMend’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 from pulling off the skin from movement or pressure due to fluid in underlying tissues.

What is the length of the microMend device Microstaple?

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

Clinical RFQ

---

​​General Questions
​
What are the indications for use of microMend?

• microMend is a primary skin closure device used to close surgical incisions or lacerations. It can be applied with or without sutures or staples to close superficial wounds that are under minimal tension. microMend can also 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.

Are there wound characteristics – e.g. location, depth, length, linearity – that microMend is best suited for?

• Location: microMend has the capability to be used to close wounds in all areas of the body. 
• Depth: microMend 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 closure on the skin surface.
• Length: microMend is designed to close wounds of any length. Multiple devices are required to close longer wounds.
• Wound type: microMend is 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 should I use microMend when I am happy with using staples or sutures?

• microMend is designed to replace sutures and staples for subcuticular closure of wounds. In healed wounds, it achieves equal tensile strength to sutures.
• microMend has demonstrated better wound closure outcomes compared to sutures in clinical studies.
• microMend is applied like a bandage making it much quicker and easier to use than sutures and staples.
• Wound closure can easily be performed by ancillary personnel, such as physician assistants and nurse practitioners.
• Time saving for the provider creates faster wound closure procedures. Studies have demonstrated that microMend is 7 times faster in closing wounds than sutures.
• microMend eliminates the need for additional superficial wound closure products such as Steri-Strips.

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

• There is extensive pre-clinical porcine data and clinical results documenting the excellent outcomes obtained with microMend.
• 5 porcine studies in which a total of over 90 full thickness skin wounds of varying length (1 to 12 cm.) were closed with microMend devices. Excellent wound closure results were documented in all wounds. There was no occurrences of infection, inflammation, wound dehiscence or other complications.
• Clinical study performed in 18 patients undergoing laparoscopic or robotic surgery in which port site wounds (3-5 per patient) were closed with either microMend or sutures (control) in each patient. Patients and surgeons in the study overwhelmingly preferred the performance of microMend to sutures, and rated microMend cosmetic outcomes superior. (Laparoscopic and Robotic Surgery Study)
• Three additional clinical studies have been performed in which microMend demonstrated excellent results in emergency medicine and dermatology.  In two dermatology studies, patients and doctors reported excellent results in terms of overall assessments of the product and cosmetic results. (Dermatology Study & Mohs Surgery Study)  A study in laceration repair has shown excellent results and the data are being compiled for publication. 

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

• Infected wounds
• Areas of high-tension
• Areas where attachment of microMend 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 known allergy to skin adhesives should not use the device.

How does microMend compare to tissue adhesive?

• Tissue adhesive requires more time to use (30 seconds to 2 minutes compared to only seconds with microMend). 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 can be easily removed and replaced if adequate closure is not achieved. If tissue adhesive enters the wound, it can lead to significant irritation/inflammation

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

• microMend has tiny skin gripping Microstaples which penetrate into the dermis making it possible to oppose and close dermal wounds. Bandages are not designed to close these deeper skin wounds. microMend 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 re-opening of the wound. 

Skin Closure Procedure & Post-Procedure Care

How long a wound can a single microMend device close?

• Each individual device is designed to close 1.5 cm. To close longer wounds, additional microMend devices need to be applied.

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

• No.

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

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

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

• Minimal to no discomfort with application and/or removal of microMend. 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?

• No, microMend should be applied to only applied to clean, dry skin. 

Should the wound be covered?

• After surgical incisions are closed, they are usually covered with a sterile absorbent dressing for 24 to 48 hours. Covering the wound for the entire duration in which microMend is attached to the skin is required in the following situations: under pant legs or other clothing areas that may cause rubbing or friction; easily soiled sites; during showering; in a patient who might pick at the wound site.
• The decision to use and when to use a dressing or tape is up to your healthcare provider.
• Never place adhesive tape or adhesive areas of a cover dressing directly over microMend. It creates a risk of loosening or pulling the device off when a dressing is removed or changed.

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

• Patient may take showers, but should minimize exposure of the wound to water. 
• The microMend 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 devices.
• Do not immerse wound under water (baths and swimming).
• Avoid activities that may produce heavy perspiration.

Can creams, ointments, and solutions be applied to microMend 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 to the skin?

• The surfaces to which microMend is applied should be clean and dry prior to application.
• microMend 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 device, carefully remove microMend and apply a new device.
• Absorptive dressings (such as gauze) should be changed as needed so that microMend is not in contact with the saturated dressing material for prolonged periods of time. Cover dressings that absorb and lock in exudate are recommended.

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

• Slight redness, itching, or pain may occur in the area where microMend is applied.

What kind of wear time can be expected with microMend?

• Wear time of up to 2 weeks is possible. The patient should wear microMend 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 reddened or excessively warm to touch, the patient should consult their healthcare provider. This may be a sign of an infection.
• If the edges of microMend 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 detaches from the wound site earlier than the number of days recommended, contact your health care provider.
• If microMend remains in place beyond the recommended treatment time or more than 14 days, patients should seek the advice of their health care provider.

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

• miroMend’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 devices were applied to the skin. These tiny puncture wounds and redness should resolve within a few days after the device is removed. If they do not, your healthcare provider should be contacted.