3M Steri-Strip S Surgical Skin Closure. Commonly Asked Questions

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1 3M Steri-Strip S Surgical Skin Closure Commonly Asked Questions What are the indications for use of 3M Steri-Strip S Surgical Skin Closure? Steri-Strip S Surgical Skin Closures are indicated as a primary skin closure to treat low-tension lacerations or surgical incisions. The closure device can also be used as an adjunct to suture or staple closures in high-tension wounds. It is also indicated as reinforcement for wounds after early suture or staple removal. What are the contraindications for use of Steri-Strip S Surgical Skin Closures? The use of Steri-Strip S Surgical Skin Closures are contraindicated for infected wounds. It is contraindicated in areas of high-tension or repetitive motion, such as incisions which cross joint lines. It is also contraindicated in areas where adhesion cannot be obtained. Potential causes of inadequate adhesion include presence of exudate, skin oil, moisture or hair. Persons with known allergy to skin adhesives should not use the device. What if I need to adjust the placement of the pad once it is applied? If pad placement is unsatisfactory, the current device should be carefully peeled back to remove and a new one applied. Are Steri-Strip S Surgical Skin Closures latex free? Yes. Steri-Strip S Surgical Skin Closures and its packaging are made from latex-free materials. Page 1 of 8

2 What kind of wear time can be expected with this product? Wear time for Steri-Strip S Surgical Skin Closures varies depending on the care of the skin closure, location of the incision and patient skin type. If the skin closure releases earlier than seven (7) days, the physician should be contacted. If the skin closure remains in place at least 14 days, the patient should seek the advice of the physician and follow the physician s instructions for proper removal. How well does this product hold wound edges together compared to skin sutures, staples or tissue adhesive? Clinical experience in many specialties has shown Steri-Strip S Surgical Skin Closures can be used alone as a primary closure to close appropriate wounds. A formal clinical trial of lacerations treated with Steri-Strip S Surgical Skin Closures versus sutures demonstrated the Steri-Strip S Surgical Skin Closures to be comparable to sutures in strength and performance. 1 Steri-Strip S Surgical Skin Closures are indicated for closure of low-tension wounds. Why should I use Steri-Strip S Surgical Skin Closures when I am happy with my subcuticular suturing and conventional 3M Steri-Strip Skin Closures? Steri-Strip S Surgical Skin Closures may allow you to reduce or possibly eliminate subcuticular suturing. This can result in time savings with good cosmetic results. Page 2 of 8

3 How does using Steri-Strip S Surgical Skin Closures compare to using skin staplers? The use of Steri-Strip S Surgical Skin Closures result in good cosmetic outcome without piercing or penetrating the skin. Steri-Strip S Surgical Skin Closures have good lateral adjustability which allows manipulation of wound edges for precise alignment prior to closure. Steri-Strip S Surgical Skin Closures can be removed and replaced with another closure if device placement is not optimal. What are the differences between Steri-Strip S Surgical Skin Closures and conventional Steri-Strip Skin Closures? Primary closure Secondary closure Adhesive enhancing skin preps Steri-Strip S Surgical Skin Closure Close low-tension lacerations & incisions, replacing skin sutures, staples, and tissue adhesive Subcuticular suture may be omitted Most any length of wound Adjunct to subcuticular or skin sutures After early staple or suture removal Not needed or recommended Steri-Strip Skin Closure Small lacerations Over subcuticular suture Arthroscopy & laparoscopy sites without suture Typically shorter length wounds To support sutures After early staple or suture removal May be required Can adhesive enhancing skin preps be used under Steri-Strip S Surgical Skin Closures? For best results Steri-Strip S Surgical Skin Closures should be applied to clean, dry skin. In an early study comparing clean, dry skin to skin prepped with either Mastisol Liquid Adhesive or Benzoin, there was no difference in adhesion. 2 Page 3 of 8

4 Can antimicrobial skin preps be used under Steri-Strip S Surgical Skin Closures? For best results Steri-Strip S Surgical Skin closures should be applied to clean, dry skin. How does Steri-Strip S Surgical Skin Closures compare to tissue adhesive? Steri-Strip S Surgical Skin Closure Tissue Adhesive Application Quickly aligns, approximates & closes Time-consuming skin edge manipulation Drying time none Bonding time 30 seconds to 2.5 mins for each segment of incision closed. Use per manufacturer s directions Adjustability Inflammation Approximation with good lateral adjustment. Can easily remove and replace device if placement is unsatisfactory Surface approximation device, non invasive limits reactive inflammation Once polymerized, adjustments cannot be made Migration of adhesive into wound may cause tissue inflammation Page 4 of 8

5 What clinical evidence do you have to support the use of Steri-Strip S Surgical Skin Closures? A prospective blinded study by Kuo et al. 1 evaluated 15 patients with surgical wounds in which half of each wound was closed with sutures and the other half closed with ClozeX (now sold as 3M Steri-Strip S Surgical Skin Closure). Sixty-six percent of blinded physician examiners rated cosmetic appearance better with ClozeX; 14% rated appearance better with sutures; 20% rated appearance equal with both. Seventy-eight percent of the examiners were completely satisfied or satisfied with ClozeX; 39% with sutures. Eighty-five percent of patients were completely satisfied or satisfied with ClozeX; 39% with sutures. In a study presented to ACEP Scientific Assembly in Boston, MA, October 2003, Hopkins et al 3 compared 30 lacerations which were repaired with either ClozeX (now sold as 3M Steri-Strip S Surgical Skin Closure) or sutures. Closure time with ClozeX was shorter and patients reported less pain with ClozeX repair. After 3 months patients were equally satisfied with outcome regardless of closure method. In addition to the studies mentioned above, physicians have been using this product for over two years with good results. Where have Steri-Strip S Surgical Skin Closures been used in clinical practice? Steri-Strip S Surgical Skin Closures have been used at various community hospitals and large medical teaching centers. Specialties where Steri-Strip S Surgical Skin Closures are currently used include cardiovascular, thoracic and vascular surgery, plastic surgery, orthopedic surgery, obstetrics & gynecology, general surgery, dermatology, urology, head and neck surgery and emergency medicine. Page 5 of 8

6 Can Steri-Strip S Surgical Skin Closures be used on any wound or surgical incision? Steri-Strip S Surgical Skin Closures are designed to be used on a wide variety of surgical incisions and traumatic lacerations. It is recommended for low-tension wounds where the configuration of the incision and surrounding tissue is relatively planar. Avoid areas of repetitive motion, over joints, areas of hightension and areas which are inherently moist; e.g., groin and axilla (armpit). Steri- Strip S Surgical Skin Closures are contraindicated for use on infected wounds. What is the effect of wound exudate or drainage on the adhesion of Steri-Strip S Surgical Skin Closures? The surfaces to which Steri-Strip S Surgical Skin Closures are applied should be clean and dry prior to application. Steri-Strip S Surgical Skin Closures are designed to adhere to dry skin and to allow drainage of exudate through the device without compromising device integrity if a secure bond is obtained at the time of application. If there is fluid under the pads or under the filaments, the device should be carefully removed and replaced with another device. Exudate that occurs after proper placement should not affect adhesion of Steri-Strip S Surgical Skin Closures. However, cover dressings should be changed as needed so that device is not in contact with the saturated dressing material for prolonged periods of time. Page 6 of 8

7 Should Steri-Strip S Surgical Skin Closures be covered? Per 1999 CDC Guideline for Prevention of Surgical Site Infection, when a surgical incision is closed primarily, the incision is usually covered with a sterile dressing for 24 to 48 hours. Coverage of Steri-Strip S Surgical Skin Closures are discretionary. If used, a non-adhesive dressing should be applied over the Steri- Strip S Surgical Skin Closures. Never place adhesive tape or the adhesive part of a cover dressing directly on the Steri-Strip S Surgical Skin Closures as there may be a risk of either loosening or inadvertently removing the device during dressing changes. Follow the protocol of your institution or physician s usual practice for covering incisions or lacerations following closure. What type of post-application care is required with Steri-Strip S Surgical Skin Closures? Steri-Strip S Surgical Skin Closures should be smoothed down completely immediately after application to ensure the best adhesion of the pressure sensitive adhesive. Consult and follow the doctor s instructions for care and removal. Otherwise, in general the use of a cover dressing over Coverage Steri-Strip S Surgical Skin Closure is optional and may be suggested for extra protection. Examples of situations when covering would be advantageous include: areas subject to friction or rubbing, to prevent site from becoming soiled; during shower if desired; if recommended by physician or to prevent access by a patient who might pick at the area. Never place adhesive tape or the adhesive part of a cover dressing directly on the skin closure as there may be a risk of either loosening or inadvertently removing the device during dressing changes. Patient may take brief showers. Gently pat dry. Do not scrub or soak the skin closure or wound area. Avoid activities producing heavy perspiration. Some discoloration of the skin closure due to adhesive residue around the outer perimeter of the pads may occur. Page 7 of 8

8 If discomfort increases or if wound area is excessively warm to touch, consult doctor as this may be a sign of infection. If edges of the skin closure begin to lift, it is recommended to trim the edge if the adhesion cannot be maintained. This will prevent accidental removal of the device caused by it sticking to clothing or other materials. If closure releases earlier than seven (7) days, consult your doctor. If the skin closure remains in place at least 14 days, seek the advice of your doctor before removing and follow the doctor s instructions for proper removal. How do I purchase Steri-Strip S Surgical Skin Closures? Contact your local 3M authorized distributor, or call References 1. Kuo, F, Lee, D and Rogers, G.: Prospective Randomized, Blinded Study of a New Wound Closure Film Versus Cutaneous Suture for Surgical Wound Closure. Dermatol Surg 32: , HTR Study No On file, 3M Clinical Research 3. Hopkins, J, et.al. (2003, October 12-14) Suturing Versus an Adjustable Tissue Closure Device for Extremity Wound Closures. Poster presented at the ACEP Scientific Assembly, Boston, MA. Mastisol is a registered trademark of Ferndale Laboratories, Inc Dermabond is a registered trademark of Ethicon, INC INDERMIL is a registered trademark of United States Surgical 3 Health Care 3M Center, Building 275-4W-02 St. Paul, MN USA For More Information Contact your 3M Health Care Sales Representative, or call the 3M Health Care Customer Helpline at These products can be ordered from your local distributor. Outside the United States, contact the local 3M subsidiary Page 8 of 8 Page 8 of 8