TissuGlu Surgical Adhesive Enables Drain-Free Recovery in Breast Reconstruction Patients

Outcomes of the SANA Gerresheim series demonstrated that effective donor-site flap closure with TissuGlu Surgical Adhesive is a viable alternative to post-surgical drains. Dr. Sonia Fertsch presented the series, which included 41 DIEP flap breast reconstructions, at the EURAPS Research Council Meeting in Pisa, Italy, last month. The annual event allows young surgeons to present top research initiatives to an audience of plastic surgeons and researchers from around the world. 
 
During a DIEP flap reconstruction, blood vessels, skin and fat of the lower abdomen are removed and utilized to reconstruct a breast following mastectomy.  The technique is widely recognized as the top option for autologous tissue breast reconstruction, but typically requires the use of several surgical drains at the donor site during recovery.  Drains may cause discomfort, anxiety and limited mobility during recovery and are often a deterrent for patients when considering treatment options.
 
The Department of Plastic Surgery at the SANA Clinic in Gerresheim, Germany, headed up by Prof. Christoph Andree, is a top center for reconstruction and performs approximately 200 DIEP procedures per year. The group, dedicated to improving recovery and acceptance of DIEP flap reconstructions, began evaluating TissuGlu Surgical Adhesive in 2015 with hopes it would enable drain-free donor site recovery.
 
“The choice of using a patient’s own tissue for breast reconstruction has clear benefits with respect to implant based reconstruction, and patients who are candidates for DIEP flap-based reconstruction appreciate the reduction in abdominal skin and fatty tissue,” said Andree. “Being able to offer this procedure without the use of donor site drains improves the patient experience in the early recovery period and leads to earlier mobilization—one of the key milestones in postoperative recovery.” 
 
Fertsch, who led the observational series, said, “Many of our patients have had experience with post-surgical drains in the past and they are very enthusiastic about the possibility that they may be able to avoid having them as part of the DIEP flap breast reconstruction procedure. It is not for all patients, but it is a welcome option for those who meet the criteria we have developed based on our clinical outcomes data.”  
 
“We were very pleased that this series report on drain-free donor site closure with TissuGlu was selected for presentation at such a high-level meeting. Prof. Andree and his team at the SANA Clinic in Gerresheim have been very attentive to the patient perspective with regards to the post-surgical recovery period and it is exciting to have their experience discussed at this venue,” added Mart Pearson, vice president of Europe for Cohera Medical.
 
Cohera Medical is developing and commercializing a line of surgical adhesives and sealants. Cohera Medical’s products are based on a unique chemical design that is resorbable, non-toxic, and easy-to-use. The company’s lead product, TissuGlu Surgical Adhesive, is indicated for use in the United States for the approximation of tissue planes in abdominoplasty procedures. TissuGlu is currently approved for sale in the European Union for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty and is being utilized in Europe to eliminate drains or reduce complications in patients undergoing large flap surgical procedures such as abdominoplasty, mastectomy, ventral hernia repair, decubitus and latissimus dorsi flap procedures. The company’s second product under development, Sylys Surgical Sealant, the first synthetic sealant designed specifically to help reduce anastomotic leaks, has received CE Mark approval in Europe as an adjunct to standard closure in ileostomy reversal procedures. TissuGlu and Sylys are the first products in a pipeline of technology that includes adhesives for surgical mesh fixation, meniscal repair and other orthopedic indications. Sylys and the other Cohera Medical products are currently available for investigational use only and have not yet been approved for sale by the U.S. Food and Drug Administration.