New study on surgical repair of advanced pressure sores (decubitis ulcer) shows >50% reduction in revision surgery and an 8 day reduction in length of stay
RALEIGH, NC, November 29, 2016 – A recent German study published in Journal of Spine (Kuhfuss I, J Spine 5:318) demonstrates that using TissuGlu® Surgical Adhesive provides both major reductions in the need for revision surgeries and shorter lengths of hospital stay after surgical flap repair for late-stage pressure sores.
The benefits of using this synthetic adhesive to bond tissue planes together after decubitus surgeries were assessed in a retrospective analysis of patients before and after TissuGlu became available. The study compared data from a group of 28 consecutive patients with standard wound closure (March 2011-November 2013) with data from a similar group of 22 consecutive patients with TissuGlu (October 2013-July 2015). Key findings reported:
- 50% reduction in the need for revision surgery in the TissuGlu group
- 8 day (35%) reduction in the mean length of hospital stay
Late-stage decubitus ulcers (also known as pressure sores, or bed sores) involve tissue necrosis and often require debridement and surgical repair or reconstruction with skin or muscle flaps. Most patients are either elderly or physically impaired (eg,spinal cord injury), which impedes self care. Complication rates after decubitus ulcer repair surgeries are relatively high and hospital stays tend to be very long compared with other types of surgery, in part because of the underlying conditions of the patients. This represents an enormous burden on patients, caregivers and society.
Dr. Ingo Kuhfuss, lead author of the TissuGlu study and Chief of the Plastic Surgery Department at St. Joseph’s Hospital in Hagen, Germany, stated: “We are very pleased with the improvements we have seen in outcomes when using TissuGlu in these surgeries. Any reduction in revision rates is a huge advance, and of course, reducing the time that these patients stay in the hospital is also important, both for the patients and for the hospital.”
Mart Pearson, VP Europe for Cohera Medical, Inc. said: “We are excited to see these results in print, as they add to a growing body of evidence demonstrating that TissuGlu can hold large tissue planes together during the critical early stages of the healing process. Dr. Kuhfuss and his team have taken the time to document the benefits of TissuGlu use in these procedures and to share them with the international medical community, which is a major step towards bringing these improvements in patient care to others in need.”
TissuGlu is a surgical adhesive designed to hold tissues together and facilitate healing after surgeries which require “undermining” between tissue planes, such as abdominoplasty (tummy tuck).
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About Cohera Medical
Cohera Medical, Inc. is a growing medical device company that 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 U.S. for the approximation of tissue planes in abdominoplasty procedures. Refer to the complete Directions for Use information available at TissuGlu.com for a full description of use information including the contraindications, warnings, precautions, benefits, and risks of use of TissuGlu Surgical Adhesive. TissuGlu is currently approved for sale in the EU 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 Food and Drug Administration (FDA) in the U.S..
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company’s future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
©2016 Cohera Medical, Inc. All Rights Reserved. Cohera Medical, Inc.®, TissuGlu® and Sylys® are registered trademarks of Cohera Medical, Inc.
TissuGlu® Surgical Adhesive is covered by one or more of the following U.S. Patents 7,264,823; 8,182,647; 8,652,293; 8,950,629. Other Patents Pending.