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Wound Closure Study Cites Superiority Of Incisive Surgical Absorbable Subcuticular Staples In Contaminated Wounds

INSORB(R)|20 Subcuticular Skin Stapler Demonstrates Lower Incidence of Infection

According to the results of a surgical wound closure study at the prestigious University of Virginia Health System Department of Plastic Surgery, the INSORB(R)|20 Subcuticular Skin Stapler was found to be "a superior choice" for closure of contaminated wounds compared to a leading bioabsorbable suture due to a "significantly lower incidence of infection." Surgical Site Infections ("SSI's") remain one of the most costly complications of surgery in the United States. The Infectious Diseases Society of America estimates that approximately 500,000 surgical site infections occur every year in the United States resulting in 3.7 million extra hospital days and more than $1.6 billion in additional health care costs.

In a scientific article, "A Revolutionary Advance in Skin Closure Compared to Current Methods", to be published in the January 2006 issue of the Journal of the Long-Term Effects of Medical Implants, the full details of a porcine multi-subject study comparing various skin closure modalities will be published. According to the recently released abstract of the study, multiple incisions on the subjects were contaminated with Staphylococcus aureus (a leading cause of soft tissue infections) and were randomly closed with three closure methods: a braided absorbable suture, percutaneous metal skin staples, and a new absorbable staple (INSORB® Absorbable Staples). Wound infection was assessed seven days after closure by clinical signs and quantitative bacterial swabs. Authors of the study concluded: "The results demonstrated that wounds closed with INSORB staples had the lowest incidence (33%) of infection, followed by percutaneous metal staples (44%). All wounds (100%) closed with [the braided absorbable] suture became infected. The incidence of wound infection directly correlated with the level of quantitative bacterial count at analysis. The [INSORB Absorbable] Staple was associated with significantly reduced closure time, less inflammation and less infection, and better aesthetic result compared to [the absorbable suture]. Compared to metal staples, the INSORB Subcuticular Staplers demonstrated comparable closure time without the need for later staple removal. In conclusion, the closure of contaminated wounds with the INSORB Staples is a superior choice to [the braided absorbable] suture because they have a significantly (p = 0.009) lower incidence of infection. The INSORB Staple is a revolutionary advance in subcuticular skin stapling."

The INSORB|20 Subcuticular Skin Stapler offers the speed of metal skin staplers with the cosmetic results and comfort of sutures. The INSORB|20 uses bioabsorbable staples that are placed under the skin and dissolve in the body within a matter of months. The staples are comprised of a tissue-friendly synthetic material and break down naturally, meaning there is no need for post-operative removal. Clinical experience has shown that patients overwhelmingly prefer the absorbable skin staples compared to metal skin staples.

"The INSORB|20 combines the benefits of the two current closure standards, sutures and metal staples, by offering the comfort and cosmetic results of sutures with the speed of metal staples," said John L. Shannon, Jr., president and chief executive officer of Incisive Surgical. "Patients now have a more comfortable, convenient and cosmetic choice for their abdominal incisions. As awareness of this device increases, we believe that patients will seek out physicians who use the INSORB|20 because the device offers so many patient benefits."

About Incisive Surgical

Incisive Surgical, Inc. is a privately-held medical device company established to develop proprietary mechanical surgical solutions for skin closure. The company's introductory product, the INSORB|20 Subcuticular Skin Stapler, is a patented new skin closure device designed to combine the cosmetic result of absorbable sutures with the rapid closure times associated with metal skin staplers. The INSORB Absorbable Staple is comprised of a biocompatible material, which is absorbed over a period of a few months. The INSORB Subcuticular Skin Stapler recently won a 2005 Medical Design Excellence Award (MDEA) for product innovation, design and engineering achievement and end-user benefit.

To view the abstract of the University of Virginia study, or for more information on Incisive Surgical, visit www.insorb.com.

     
   President & CEO
   Incisive Surgical, Inc.
   Plymouth,    MN,    55447
   USA
   (952) 591-2543, ext. 18 (phone)
   (952) 591-5989 (fax)
   shannon@insorb.com
   www.insorb.com
  

     
   Chief Financial Officer
   Incisive Surgical, Inc.
   Plymouth,    MN,    55447
   USA
   952 591-2543. ext 22 (phone)
   952 591-5989 (fax)
   McClurg@Insorb.com