Preventing leaks in surgery

The use of products to prevent leakage, whether of air, blood, or other liquids during surgery has always been variable and traditionally surgeons have resorted to products not designed for purpose, such as haemostatic felts, to attain some form of seal. An interesting alternative to surgical sealants has been developed by TissueMed, for use in a range of surgical procedures, offering surgeons a solution to seal potentially leaky tissues in seconds. It took five years to develop and refine the product. Probably the most challenging aspect was to develop a fast acting but stable polymer with ten times the adhesive power of liquid glues, while ensuring that the material remained user friendly and safe for in vivo use. Early in the product development process the company discounted the use of low strength PEG-based hydrogel technology used by its competitors and launched the first product, TissuePatch3 to the cardiothoracic community in 2007. For operating surgeons, a selfadhesive, synthetic surgical sealant film represents a useful addition to their existing armoury of tools. Practical applications start with sealing suture or staple lines with an instantly available, instantly functional, biologically near-invisible film, which has a sustained clinical effect until it is eventually broken down in the body. The simple principle of being able to stick materials to the internal organs of the body also offers future promise, including maybe even the closure of wounds. It could also be used in procedures where surgeons prefer the tissues to be non-adherent to each other, for example where nerves or vessels are involved, as in thyroid surgery. By applying a thin barrier to a tissue surface, overlying tissues are prevented from becoming associated with that surface and in so doing normal anatomical planes are preserved. TissuePatch3 was first CE-marked in 2007 and indicated for sealing air leaks during lung surgery, and leakage of blood and other fluids. A year later came TissuePatchDural, dedicated to neuro/spinal surgery use. In 2010 TissuePatchThoracic was introduced to meet the needs of thoracic surgeons, again for air leak reduction purposes. In fulfilment of its ongoing post-market surveillance requirements, the company has also been accumulating clinical evidence. Consultant oral, maxillofacial, head and neck surgeon Mr Leo Cheng who works between Homerton, Royal Lonodn and St Bartholomews Hospitals, has existing armoury of tools. Practical applications start with sealing suture or staple lines with an instantly available, instantly functional, biologically near-invisible film, which has a sustained clinical effect until it is eventually broken down in the body. The simple principle of being able to stick materials to the internal organs of the body also offers future promise, including maybe even the closure of wounds. It could also be used in procedures where surgeons prefer the tissues to be non-adherent to each other, for example where nerves or vessels are involved, as in thyroid surgery. By applying a thin barrier to a tissue surface, overlying tissues are prevented from becoming associated with that surface and in so doing normal anatomical planes are preserved. TissuePatch3 was first CE-marked in 2007 and indicated for sealing air leaks during lung surgery, and leakage of blood and other fluids. A year later came TissuePatchDural, dedicated to neuro/spinal surgery use. In 2010 TissuePatchThoracic was introduced to meet the needs of thoracic surgeons, again for air leak reduction purposes. In fulfilment of its ongoing post-market surveillance requirements, the company has also been accumulating clinical evidence. Consultant oral, maxillofacial, head and neck surgeon Mr Leo Cheng who works between Homerton, Royal Lonodn and St Bartholomews Hospitals, has Mr Cheng has undertaken around 30 thyroid surgeries using TissuePatch surgical sealant and when comparing patients having similar surgery without using it he has identified a reduction in the blood drained the following day in patients where the product was used. “I believe that it also has an impact in the number of bed days because if there is a significant amount of blood drainage we tend to wait longer before discharging the patient,” said Mr Cheng.”Since I started to use TissuePatch most of the drains come out between 12 and 24 hours after surgery. Mr Cheng has also found the product to be easy to use. He said: “You can actually take the pack straight from the shelf as it does not need to be stored in the fridge. Because it is adhesive it does not come off after you position it in the patient and apply moderate pressure onto it. “I really love to use the product in my head and neck procedures. In thyroid procedures surgeons often use cellulose based haemostats to put on the tumour bed to act as a barrier between the recurrent laryngeal nerve and the suction drain. I find TissuePatch3, being only 40 microns thick and resorbable, provides a good solution to separating the nerve from the suction drain tube and it also acts as a barrier and a haemostat to reduce oozing from the tumour bed.” Mr Cheng also usesTissuePatch3 and its sister product TissuePatchDural for voluntary work he undertakes on Mercy Ships, which travel to some of the worlds poorest countries to offer medical assistance to those who have no access to this type of healthcare. “In Africa I saw cases that I never imagined I would get involved in. For example, in this country I remove benign tumours from a patient’s face with no change to the outside. I can take the tumour out within half an hour under day case. In Africa I saw really big tumours, extending down the neck. TissuePatch3 is useful for such large surgical tumour beds in thyroid surgery and in chylous leak to seal off residual leaks after removal of these big teratomas. I also use its sister product, TissuePatchDural, for encephaloceles to seal off cerebrospinal fluid (CSF) leaks.”

Closure of the dura

The use of this surgical sealant in neuro and spinal surgery has also been mentioned in a report from the Department of Neurosurgery at the University of Bonn, Germany1 which stated: “The use of TissuePatchDural sealant film ensured water-tight closure of the dura. Postoperatively, the patient recovered without any complications. Three months postoperatively the patient was contacted again. No irregularities have been documented. The film does not require lengthy preparation in advance and was easy to use, covering the leaks and being easily conformable to the underlying soft structures. For small leaks along the sutured dura, TissuePatchDural is a convenient material providing easy, safe and fast water-tight closure.” Della Puppa et al2 from the Department of Neurosurgery, Padua University Hospital in Italy said: “CSF leak is an adverse event that can affect the postoperative course of neurosurgical patients. Despite the large intra-operative use of effective strategies, as well as specific devices, post-operative occurrence of CSF leak has been recently reported in up to 11% of cases. TissuePatchDural is a sealant that is now available in neurosurgery to repair dural defects and, consequently, prevent the postoperative formation of CSF fistulas. This synthetic absorbable film can actively create a firm temporary connection with the external dural surface and thus favour a satisfactory healing of the wound.” The authors reported their preliminary experience about the use of the device in 12 selected patients, saying: “The device is worthy of interest because it represents a new strategy in order to solve the problem. In contrast to biological patches (i.e. fat or pericranium) TissuePatchDural has the property of quickly developing a tight connection with the dural surface by means of covalent links. It is a sealant, like biological glues, but unlike them it is a large film, able to cover large dural surfaces affected by multiple defects. Moreover, the application does not take time to prepare as with biological glues. In our current dural defect management in selected patients its use has reduced repair time and improved final results.”