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TissuGlu® Surgical Adhesive

Holding Strong, Healing Naturally™:
Click above to view animation of how TissuGlu Surgical Adhesive* works.

A new era for surgical adhesives.

TissuGlu® Surgical Adhesive* is a lysine-derived urethane adhesive with a unique chemical composition that cures in the presence of moisture. The adhesive is resorbable, biocompatible for internal use, uses no human or animal based ingredients and forms a bond between tissue layers that is five times stronger than any other product available today for this indication.1

Cohera Medical, Inc.® researchers developed TissuGlu Surgical Adhesive to serve the needs of plastic and aesthetic surgeons who perform abdominoplasty (tummy tuck) and other procedures that require the creation of large planar flaps of tissue. It is indicated in the European market for the approximation of tissue layers where subcutaneous deadspace exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

Seroma formation in large flap procedures

Postoperative seroma formation following extensive undermining and wide dissection of tissues as required in the preparation of large flaps (e.g. abdominoplasty, latissimus dorsi) has been reported in recent patient series to occur in 13% to 50% of patients following surgery.2-6 Seroma formation is believed to result from the “dead space” created between tissue layers during flap elevation, as well as from shearing forces between the tissues after surgery.7

By helping to reduce the accumulation of wound exudate in large flap procedures, TissuGlu Surgical Adhesive may also reduce the risk of seroma formation and other complications associated with post-surgical fluid accumulation.

Download Retrospective Study White Paper

White Paper: Serous Fluid Drainage and Seroma Formation after Flap Procedures Requiring Wide Undermining: A German Multicenter Evaluation

In a retrospective chart review conducted at six centers in Germany using a standardized data collection protocol for surgical procedures involving wide dissection, including cosmetic (CA) and medically indicated (MIA) abdominoplasty and circumferential dermo-lipectomy (CDL), as well as flap procedures (TRAM, DIEP and latissimus dorsi flap), researchers found a mean rate of seroma formation for all patients of 18.5%, ranging from 6.7% for patients undergoing CA to 42.1% for patients undergoing MIA or CDL procedures.8

Incremental post-operative interventions or procedures required for patients with seromas in this patient series (2.3 procedures per patient) added increased costs, and these tended to be concentrated in the procedures with lower payment levels. Medically indicated abdominoplasty, which had the lowest reported mean reimbursement value (€4,306), had one of the highest reported rates of post operative seroma formation (41.7%) and the highest mean number of post operative interventions related to fluid accumulation (2.7).8 Download the full report here.

Reduced need for surgical drains.9

TissuGlu Surgical Adhesive helps to reduce fluid accumulation by reducing dead space in the surgical wound. The adhesive holds tissue layers together in close approximation and resists shearing forces by forming a bond that surpasses that of fibrin-based sealants by a multiple of five.1

Clinical Study Results: Mean total Drain Volume

  • Total drain volume graph
    In a multicenter, prospective randomized trial comparing patients treated with TissuGlu Surgical Adhesive to a control group, patients in the control group experienced a 45% higher mean total drain volume compared to the treatment group (303.5 ± 240.8 mL vs. 208.7 ± 138.23 mL; p = 0.14).1

Patient follow-up visits

By helping to reduce post-surgical fluid build-up following abdominoplasty (tummy tuck) procedures, TissuGlu Surgical Adhesive may reduce the time interval to drain removal and help patients avoid multiple follow up visits for drain related complications, including interventions to aspirate accumulated fluids.

Potential shorter hospital stays

Use of TissuGlu Surgical Adhesive may contribute to reduced hospital length of stay by helping to reduce the average length of time to drain removal for patients undergoing abdominoplasty (tummy tuck) procedures.

Potential increased patient satisfaction

Use of TissuGlu Surgical Adhesive may reduce the need for uncomfortable and inconvenient post-operative drains and the interventions that are subsequent to fluid accumulation following abdominoplasty (tummy tuck) procedures. Time to ambulation after surgery may be reduced, due to the earlier removal of drains.

Simple, fast and easy application.

TissuGlu Surgical Adhesive stores at room temperature, requires no mixing and comes prepackaged in an ergonomic applicator featuring a Multi-Tip™ Pivoting Head that facilitates rapid application.

Bonding strength comparison

  • Bonding strength comparison graph
    The bond formed by TissuGlu Surgical Adhesive is significantly stronger than fibrin or PEG-based products and has equivalent strength to topical cyanoacrylate adhesives.1

Curing Strength Curve

  • Curing strength curve graph
    TissuGlu Surgical Adhesive begins to cure immediately when exposed to moisture in the body, achieving a strong bond in 20 minutes, and is fully cured in less than an hour.

Link to Aesthetic Plastic Surgery JournalRandomized, prospective study of TissuGlu® Surgical Adhesive in the management of wound drainage following abdominoplasty. Aesthetic Plas Surg. 2011 Dec 29. DOI:10.1007/s00266-011-9844-3.

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Cohera Medical has engaged HealthLink Europe to act as its European Authorized Representative.

References:

  1. Data on file.
  2. Andrades P, Prado A, Danilla S, Guerra C, Benitez S, Sepulveda S, Sciarraffia C, De Carolis V. Progressive tension sutures in the prevention of postabdominoplasty seroma: a prospective, randomized, double-blind clinical trial. Plast Reconstr Surg. 2007; 120:935-46.
  3. Neaman KC, Hansen JE. Analysis of complications from abdominoplasty: A review of 206 cases at a university hospital. Plast Surg. 2007; 58:292-8.
  4. Hensel JM, Lehman JA, Tantri MP, Parker MG, Wagner DS, Topham NS. An outcomes analysis and satisfaction survey of 199 consecutive abdominoplasties. An Plast Surg. 2001; 46:357-63.
  5. Najera RM, Asheld W, Sayeed S, Glickman LT. Comparison of seroma formation following abdominoplasty with or without liposuction. Plast Reconstr Surg. 2011; 127:417-22.
  6. Beer GM, Wallner H. Prevention of seroma after abdominoplasty. Aesthet Surg J. 2010; 30:414-7.
  7. Kim J, Stevenson TR. Abdominoplasty, liposuction of the flanks, and obesity: Analyzing risk factors for seroma formation. Plast Reconstr Surg. 2006; 117:773-9.
  8. Kwak M, Müller D, Ziegler U, et al. Serous Fluid Drainage and Seroma Formation after Flap Procedures Requiring Wide Undermining: A German Multicenter Evaluation. White Paper. 2011.
  9. Walgenbach KJ, Bannasch H, Kalthoff S, Rubin JP. Randomized, prospective study of TissuGlu® Surgical Adhesive in the management of wound drainage following abdominoplasty. Aesthetic Plas Surg. 2011 Dec 29. DOI:10.1007/s00266-011-9844-3.

*Disclaimer: TissuGlu Surgical Adhesive received European CE Mark in 2011. Currently, TissuGlu Surgical Adhesive is approved for investigational use only in the United States and is not approved for sale or marketing in the U.S. or any other country outside of the EU. No other Cohera Medical product is currently approved for sale in any country.