Using the new hemostatic gelatin GELITA-SPON RAPID³ to treat parenchymatous organs – a clinical observation

Current possibilities of influencing local hemostasis

Parenchymatous organs are characterized by high blood perfusion. Although large veins can easily be ligated, problems arise with capillary bleeding from these organs, particularly in cases such as bleeding from the sinusoidal structures of a liver (1). Surgeries performed on parenchymatous organs, both elective resections and traumatological surgeries, pose the risk of blood loss. Surgeons must minimize the risk of blood loss in order to maintain the hemodynamic stability of patients using the least possible volume of blood derivatives. It has been proven that the application of a blood derivative affects the immune status of patients (2), increases the risk of postoperative infections (3) and has a negative effect on the potential recurrence of oncological diseases (3). Bleeding from parenchymatous organs is usually stopped by surgical injection or resection of malacic tissue. Today, surgeons must employ precise surgical skills and modern instrumentation; on top of that, they should also have access to up-to-date local hemostatics and be familiar with them. In general, there are two groups of local hemostatics: on one side products based on oxidized cellulose and gelatine; and on the other, products containing procoagulant factors. The efficiency of the first group of products is ensured by the natural capacity of gelatine and oxycellulose to activate hemostasis and absorb fluids on a capillary level and through the special structure of their surfaces. Randomized controlled studies based on an animal model proved a higher efficiency of bovine collagen over oxycellulose and equine collagen (4). Bovine collagen has been demonstrated to induce a milder inflammatory response of the organism (4). The products of the latter type carry procoagulant factors such as thrombin or fibrinogen that directly activate hemocoagulation cascade. These two types show different levels of efficiency as well as having a significant difference in cost-effectiveness. Of course, the benefit to the patient is the most important criterion for using either of them. But in order to ensure this benefit, surgeons must have personal experience with an extensive portfolio of local hemostatics and be able to select products with the appropriate indication.

Testing and assesment of GELITA-SPON RAPID³

The six-month study was carried out by two surgeons experienced in organ surgery between 1 January and 30 June 2013. Both of them also had experience with the application of local hemostatics (oxycellulose, gelatine and procoagulant factor products). Routinely, all patients received perioperative low molecular weight heparin (Clexane) to prevent thromboembolic disease. GELITA-SPON RAPID³ was applied to the resection area following 10 liver resections (6 atypical resections due to metastasis, 3 resections of liver metastasis to the extent of liver segment, and 1 left hemihepatectomy due to liver tumor) and 11 lung resections (3 atypical resections of the lung or treatment of a fresh area after decortication, 8 resections to the extent of a lobe of the lung – 2 lobectomies were done by thoracoscopy). During the study, the product was also used to treat pancreatic tissue (1 case) and a splenic bed after a splenectomy (1 case) – these cases were not assessed due to the small size of the patient sample.

The product was applied using the standard method in both groups (liver and lungs). After surgical treatment for bleeding, GELITA-SPON RAPID³ was applied on the resection area and mildly pressed down with a wet drape for 1 minute. The surgeon assessed the arrest of capillary leakage, adsorption capacity and adhesion to the tissue.

Questionnaire protocol:

The first record was made immediately after the product was applied. The surgeon assessed the following parameters: hemostatic capacity, absorption capacity, adhesion to tissue, convenience of handling and application, complications, benefits and disadvantages in using the product. The assessors were asked whether they would use the product in the same indication again and whether or not there were any limitations in leaving the product in a patient’s body.

The second record was made after the completion of the study. The surgeon evaluated the benefits of GELITASPON RAPID³ in terms of time saving and affordability, identifying the benefits and drawbacks of its use. With the benefit of hindsight, the surgeons were asked whether they would use the product in the same indication again or whether they would use it in any other indication. The assessment was based on the following 5-point scale: excellent, good, satisfactory, poor, unsatisfactory).

Conclusion

An analysis of a total of 21 questionnaires completed by 2 surgeons, generally showed a positive assessment of the product. The overall assessment in Table 1 was based on the mean of each individual assessment. Graphs demonstrate a percentage (%) of responses concerning a given property of the product. In both groups of operated organs (lungs and liver), the main function of the product, i.e. hemostatic capacity, was rated as excellent (58% excellent, 42% good). The handling and convenience of the products’ application was perceived positively as well. The absorption capacity in both groups was defined as good (23% excellent, 67% good, and 10% satisfactory). A significant difference was observed in the products’ adhesion to particular tissues. In the liver group, adhesion was viewed as good (30% excellent, 50% good, 20% satisfactory), whereas in the lung group it was perceived as poor (18% good, 27% satisfactory, 37% poor, 18% unsatisfactory). The reasons for the decreased adhesion to the tissue are detailed in ‘‘Discussion’’.

In practice, the application of the product via endoscopic ports during mini-invasive surgery was tested in two cases. The material characteristics of the product make it possible to be applied using a folded sponge inserted through an endoscopic port, it is then unfolded and applied to the body cavity.

The surgeons participating in this study pointed out the excellent hemostatic properties, easy handling and cost-effectiveness of the product.

No adverse effects were observed during application of the product or its resorption after the surgery. No postoperative bleeding was noted.

Both surgeons recommend using GELITA-SPON RAPID³ following liver resections.

Every time a medical device or pharmaceutical is used, it increases costs. However, money well spent can actually save time and excess cost. From an economical perspective, it is best for a surgical facility when patients are operated on without complications, are sent home early or at least on schedule, and therefore remain satisfied.

Local hemostatics reduce the risk of postoperative bleeding or formation of postoperative hematomas that can cause inflammatory complications (5). Perfect hemostasis makes it possible to extract postoperative drains sooner, which accelerates both the rehabilitation and verticalization of patients and shortens the hospitalization time necessary for recovery.

In the group of products with no active ingredient, the hemostatic effect of GELITA-SPON RAPID³ was viewed by both surgeons as excellent.

Time of drain extraction after liver surgeries was retrospectively investigated in the same number of patients who were operated on last year in our department. In comparison these patients’ drain extraction time was reduced, on average, by 0.82 days.

The surgeons believe that in liver surgeries GELITASPON RAPID³ indicated particularly well for the treatment of planar resection areas. In these cases, it has an excellent hemostatic effect and an amazing capacity to adhere to liver tissue. In the case of the lung surgeries, the product has good hemostatic properties when it is appropriately pressed down on to the tissue.

However, after inflation and breathing movement of the lung, it does not adhere to the tissue properly. This is undoubtedly the result of the lungs’ natural movement, but it may also be caused by the differing characteristics between lung and liver tissues. As soon as the adhesion of the product to the lung tissue improves, it will be indicated for hemostasis both to reduce blood loss and to prevent air leaks from pulmonary resection areas.

The excellent material characteristics of the product facilitate its application via working ports during mini-invasive surgeries.

The authors believe that the product will be very efficient in the treatment of other parenchymatous organs such as the spleen and kidney. As far as the spleen is concerned, conservational operations after traumas come into question. The authors did not have the opportunity to test the product in this indication due to the short period for testing (6 months) and low frequency of conservational operations on the spleen – today, conservative surgery is preferred in cases whose degree of injury is below 3, as well as radiological methods (6), are often recommended in patients with stable hemodynamics. A multicentric longitudinal study should be designed to investigate this indication.

Final recommendation for the use of GELITA-SPON RAPID³

GELITA-SPON RAPID³ is a new, efficient and cost-effective product, used to ensure the local hemostasis in the non-surgical bleeding of parenchymatous organs. The product is made from purified porcine gelatin with a structurally modified surface for a better hemostatic effect. When used as recommended, the product displays excellent results after it is applied to the resection area of the liver (Figure 1).

When it was used to treat the resection area of the lungs, its capacity to adhere to tissue was lost due to the lungs’ inflation and natural breathing. No adverse effects were observed in any case; none of the patients showed postoperative bleeding or had to undergo further surgery.

Considering the performance of the product in liver surgery, it should also be efficient in cases of kidney resection and conservational operations after splenic traumas.

In order to improve the efficacy of the product in lung surgery, the authors suggest that the adhesive capacity of the product could be optimized by using an adhesive material or by modifying the structure of the product surface further.

MUDr. Peter Hromádka

Slovanská 731

46312, Liberec 10

e-mail: peter.hromadka@nemlib.cz

Telefon: 602544648