Floseal baxter

One was on aspirin and another on low molecular weight heparin. Any large vessel bleed was dealt with by conventional surgical techniques of suture ties and clips. Table 1 outlines the different procedures included in this trial and Table 2 highlights the extent of thyroid surgery performed. Post-operatively, patient length of stay, drain insertion time, bleeding and any complications such as haematoma formation were recorded. Adverse incidents were the main outcome measure, including allergic reaction, wound breakdown, wound infection and thrombosis.

Secondary outcome measures were haematoma formation, hospital stay, drain times and output. A total of 42 procedures were included in the study. Three patients had relevant past medical history of immunosuppression diabetes and immunosuppressive medication and two were current cigarette smokers.

The mean operation time was minutes range: 30— minutes. Wounds were reviewed in the outpatient clinic two weeks after the procedure to confirm the absence of wound infection.

The mean length of hospital stay was 2. With regard to drains, a surgical drain was used in 30 procedures and in 5 cases this was bilateral with the size ranging from 10F to 18F. The average time to drain removal was approximately 60 hours range: 24— hours with a maximum total drain output of ml.

Three patients developed complications of haematoma formation post-operatively Table 3. Patient A developed a wound haematoma after 45 minutes following a superficial parotidectomy lasting 60 minutes with no drain inserted initially and was taken back to theatre where an evacuation procedure was undertaken. The drain was removed after 48 hours with no complications. Patient B developed a haematoma following a left parotidectomy operation time: minutes that was managed conservatively.

The drain inserted during the procedure was removed after 48 hours with no further complications. Patient C underwent an elective left hemithyroid procedure lasting minutes that was complicated by haematoma formation observed while the patient was still in recovery. The patient was taken back to theatre approximately two hours later for evacuation of the haematoma where a small venous bleed was identified and cauterised with bipolar diathermy.

The drain was removed after 48 hours with no further complications. There are many topical haemostatic agents available that use a collagen-based matrix. The final material is excellent at conforming to irregular surgical cavities and clot formation is promoted by the presence of thrombin. HNS differs from other system surgery. The numerous cranial nerves potentially encountered during surgery are quite unique and nerve dysfunction would be particularly pertinent in the context of vital organ functioning swallowing, breathing, voice and facial cosmesis.

Rapidly evolving post-operative haematomas may within a very short period of time result in irreversible nerve ischaemia and dysfunction, causing vocal cord palsies, facial nerve palsies, airway oedema and obstruction. These complications all have significant morbidity if not potential mortality attached to them.

Given the extensive vascular supply to the head and neck region, careful and precise control of bleeding is essential to avoid complications of haematoma formation and catastrophic blood loss. As a baseline study intended to allow us to plan a more extensive investigation protocol, we have sought to demonstrate that haemostatic sealants such as Floseal have no deleterious effects in regular HNS use.

It was confined initially to more complex scenarios where intra-operative haemostasis was deemed troublesome but with its usefulness as a surgical aid gradually realised, its potential for a wider prophylactic application and role has started to be debated. Worryingly, in the head and neck region, a similar finding may result in misdiagnosis and unnecessary further procedures. In Thomas and Tawfic reported on three cases of post-operative pelvic pain in patients who had undergone pelvic surgery.

Although none of our patients reported excessive post-operative pain, this could be an important outcome to measure in any future trials. In particular, this study aimed to evaluate both the incidence of adverse events and outcome measures. Ann R Coll Surg Engl. Author information Article notes Copyright and License information Disclaimer.

A Ujam: moc. Accepted Feb This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Table 1 Procedures included in this trial. Open in a separate window. Table 2 The extent of thyroid surgery performed. Procedure Number of cases Total thyroidectomy 9 Hemithyroidectomy initial or completion 6 Isthmusectomy 3 Total Case reports and case series studies were excluded.

A total of 27 papers met the selection criteria and were analysed. Peer Review reports. Surgery procedures, independently of the type, usually follow a common approach. The major surgical steps are incision, dissection, exposure, resection, haemostasis, restoring anatomy and closure.

Among the procedures, only anatomy differs, but the challenges are always the same. The typical surgical challenges are bleeding, healing complications, leakage and adhesion formation. Improperly addressing of these challenges, could impact on patient outcome such as haemorrhagic shock, blood replacement, longer hospital stay in case of bleeding. Surgical bleeding, concretely, can be associated with an increased risk of morbidity and mortality across all surgical areas. Excessive bleeding complicates surgery and often leads to longer hospital stays, increased healthcare service utilisation, and higher healthcare costs, among other negative consequences[ 1 ].

The length of hospital stay is approximately 2—2. Efforts to control surgical bleeding and the use of blood transfusions are thus needed to reduce healthcare consumption and costs. The most frequent methods typically used to achieve haemostasis were pressure dressings and sutures, but also numerous products have been developed to achieve the same aim by different ways, such as topical haemostatic agents HA e.

Although there is no consensus on how to best approach haemostasis, the number of options available to the surgeon continues to grow. Several factors are important when evaluating the quality of HAs and devices, but the most important are the ability of a product to achieve and maintain haemostasis and the speed with which bleeding is controlled[ 4 ].

Conventional methods for control bleeding are for example electrocautery, suturing, manual compression or ligatures, among others. Gelatine-thrombin matrix sealants are commonly used intra-operatively acting at the end stage of the coagulation cascade to facilitate fibrin formation, promoting coagulation and minimising blood loss.

These agents are a mixture of a flowable gelatine matrix bovine or porcine and a human-derived thrombin component. English-language articles published during the last decade from 1 January to 31 August were identified. A secondary search among the citations of the articles retrieved in the initial search was performed to ensure that all relevant studies were included.

Abstract and poster publications were only considered if they were published within the past two years, as information about ongoing studies may be available as partially published research, such as conference abstracts[ 5 ]. In contrast, case series and case reports were excluded from the review. The studies were then separately assessed based on surgery type. Two reviewers screened the references based on the defined inclusion criteria and extracted the data.

The data were collected by one author ME and checked by a second author IO , and all disagreements were resolved through discussion. Figure 1 shows the flowchart of the selection process, indicating the potentially relevant studies identified, the studies retrieved for more detailed evaluation, the included studies, and the excluded studies[ 6 — 32 ].

Flow diagram of the selection process to identify studies to be included. A total of 27 studies were ultimately identified and selected[ 6 — 33 ]. An overview of the characteristics of these 27 evaluations, including a total of 39, patients undergoing surgical procedures, is shown in Table 3. Six studies involved sinus surgery Finally, three total knee arthroplasty TKA studies Fourteen studies In these studies, blood loss and the time to achieve haemostasis were the most reported outcomes used to assess treatment efficacy.

Other outcomes included the length of hospital stay LOS and postoperative pain. A synthesis of the selected studies is presented in Table 3. The population targeted in our review was any patient undergoing surgical procedures. To aggregate the results, studies included in this systematic review are grouped by surgical procedure. In a retrospective database analysis of a U.

Surgeries included in the analysis were open valvuloplasty, valve replacement, and coronary artery bypass. The primary outcome of the study was the LOS. Although the rates of revision for bleeding and of minor complications were not significantly different between groups in the overall cohort, there were significant differences in the subgroup of patients with evident intraoperative bleeding.

In this subgroup of patients, 4. Also in this subgroup, minor postoperative complications, including renal failure, respiratory insufficiency, and inotropic support lasting for more than 24 hours, occurred in Additionally, 54 surgical revisions for bleeding and blood transfusions would be avoided. All were US studies, two of them were prospective and the other one retrospective.

In both the prospective studies the endpoint of measurement of blood loss through drain output was the same[ 9 , 10 ], however the results were different. In the retrospective study the principal endpoint was the measurement of haemoglobin levels, which is an indirect way to estimate blood loss in any surgery type[ 11 ].

Four prospective, randomised trials in tonsillectomy and adenoidectomy were identified and detailed on Table 6. Two of these trials were European studies that included all patients over 16 years of age[ 12 , 13 ]. The other two were US studies and included only children mean age 7. The European studies were performed in patients over 16 years of age undergoing tonsillectomy. Five of these 6 studies were completed in North America, and the other one was performed in Europe.

Chandra et al. Patients were followed for 1. In all, 20 patients received the same treatment on both sides, whereas 25 patients received a different treatment on each side.

The primary outcome measure of the study was total operative blood loss. The study concluded that there were no significant differences in intraoperative bleeding between the two groups.

The groups were also comparable in bleeding grade and the number of nasal pledgets used. The comparators were different between the studies; thus, the results also differed. Six evaluations of urologic procedures were identified. All were clinical evaluations, two of which also aimed to estimate the cost savings of each alternative. The primary endpoints in all of these studies were different and all details were collected on Table 9.

Additionally, Guzzo et al. A different surgical procedure was evaluated in a study by Pace et al. The authors observed significantly higher rates of successful haemostasis and a shorter time to haemostasis 8. Four of these patients had to be treated with percutaneous puncture, and six needed drainage and subsequent laparoscopic fenestration. In order to avoid exclusion of studies related to sealants consisting of gelatine and matrix components it was important not to restrict the search strategy too much.

The large number of articles identified in our literature review could signify the relevance of research in the field of surgical sealants. Some limitations can be taken into account concerning this review. Some of them common to any other systematic reviews, were inherent to the methodology used.

However, this risk should be minimal because of the large number of articles that were initially found. However, during the secondary search among the citations of the articles retrieved in the primary search, it was observed that three studies were mentioned in many of the reviewed articles. This review reflects the difficulty of comparing results because all 27 finally identified studies revealed a wide variety of surgery types cardiac surgery, ESS, LPN, and adenoidectomy , and comparators electrocautery, conventional methods, and other HAs.

However, this cannot be extrapolated if economic evaluations are not performed. Reduction of both intra- and postoperative blood loss would reduce the need for blood transfusions and the LOS, and thus greatly reduce costs. Fifteen of the 26 clinical evaluations considered in this review with the exception of an economic study[ 8 ] included 50 patients or more, and 12 of the studies had sample sizes of less than 50 patients. However, Article Google Scholar.

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Local hemostasis was achieved, but not maintained and metrorrhagia resumed requiring transfusion. FloSeal was applied intrauterine and to the vaginal walls, and stable hemostasis was achieved after 2 h. At the one-month post-delivery visit, anatomic and physiological status had returned to normal, although the patient had low fibrinogen and prothrombin activity.

This case demonstrates the safety and effectiveness of FloSeal in combination with conventional procedures to achieve hemostasis in postpartum bleeding in a patient with hypofibrinogenemia. Abstract FloSeal hemostatic gelatin matrix with a human-derived thrombin component; Baxter Healthcare, Deerfield, IL, USA hemostatic matrix is used as an adjunct to hemostasis when conventional procedures have proved ineffective.

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