Hemostatic effect and safety evaluation of oxidized regenerated cellulose in total knee arthroplasty- a randomized controlledtrial.

BACKGROUND: Oxidized regenerated cellulose (ORC) is a type of biodegradable hemostatic material, which has been widely used in the field of surgery. However, its hemostatic effect in patients undergoing total knee arthroplasty (TKA) is uncertain. Accordingly, this study investigated the effectiveness and safety of ORC in patients receiving TKA. METHODS: Seventy patients undergoing unilateral TKA were randomized into blank control group and ORC (2 pieces of ORC placed in the joint cavity) groups. Then, the two groups were compared for primary (perioperative blood loss [total blood loss, intraoperative blood loss, and hidden blood loss] and hemoglobin drop values) and secondary (coagulation indicators, inflammatory indicators,operation time, and complication rates) outcomes. RESULTS: The total blood loss in the ORC group was 902.32 ± 307.82 mL, which was statistically significantly lower than that in the control group (1052.25 ± 308.44 mL) (P < 0.05). Postoperative hidden blood loss was also statistically markedly lower in the ORC group (801.61 ± 298.80 mL) than in the control group (949.96 ± 297.59 mL) (P < 0.05). There was no significant difference between the two groups in terms of coagulation indicators, inflammatory indicators, operation time, and complication rates. CONCLUSION: In conclusion, our prospective RCT study proved that regenerated oxidized cellulose can be used safely in vivo and can effectively reduce postoperative blood loss in patients, which is a potential method for preventing blood loss after TKA. TRIAL REGISTRATION: This prospective RCT was reviewed and approved by the Ethics Committee of Honghui Hospital of Xi'an Jiaotong University (No: 202,211,007) and was designed and conducted according to the rules of the Declaration of Helsinki. Written informed consent was obtained from patients or their legal guardians.

Oxidized Regenerated Cellulose Sheets in Postoperative Intrathoracic Adhesions.

Adhesiolysis is often necessary in intrathoracic adhesion during ipsilateral repeat lung resection. This procedure has a risk of surgical complications, including unintentional intraoperative damage of the pulmonary vessels or lung parenchyma. We used an oxidized regenerated cellulose (ORC) sheet to prevent intrathoracic adhesion after lung resection in 55 patients. The sheet was placed on the surface of the resected region and on the lung surface under the wound. No major postoperative complications were observed. Three cases underwent ipsilateral thoracic surgery for the treatment of lung malignancies, and there were no intrathoracic adhesions around the ORC sheet-covered area.

Surgicel-Related Uptake on Positron Emission Tomography Scan Mimicking Prosthetic Valve Endocarditis.

A 78-year-old patient who underwent an aortic valve replacement presented 6 months later with clinical symptoms suspicious for prosthetic valve endocarditis. Echocardiography showed no features suggestive of endocarditis, but a positron emission tomography/computed tomography with fluorine-18-fluorodeoxyglucose (18F-FDG PET/CT) scan showed an area of hyper-uptake around the ascending aorta. We realized that the sheet of Surgicel (Ethicon, Bridgewater, NJ) hemostat had been placed over the aortotomy suture line at the time of surgery. Another follow-up PET/CT scan performed 22 months later showed that the hyper-uptake focus remained persistent. False-positive hyper-uptake on an 18F-FDG PET/CT scan owing to local hemostatics should be considered when interpreting the findings of this technique.

Use of Oxidized Regenerated Cellulose as a Hemostatic Agent in Neurosurgery: Appraisals and Recommendations to Prevent Postoperative Complications and Facilitate Follow-Up.

Neurosurgical hemostasis can be performed with bipolar coagulation and with the support of several dedicated biomaterials including oxidized regenerated cellulose (ORC; e.g., Surgicel®, Johnson & Johnson, New Brunswick, NJ, USA). Oxidized regenerated cellulose is a sterile absorbable fibrous biomaterial that has become a major local hemostatic agent thanks to its ease of use, favorable biocompatibility and bioabsorption characteristics. However, some postoperative issues associated with its use, such as allergic reaction, seroma, foreign-body reaction with compressive neuropathies and misdiagnosis during follow-up, have been reported. These complications could compromise clinical outcomes with a negative impact on patient quality of life and sometimes require risky major surgical procedures. An understanding of the specific properties of ORC combined with adequate surgical expertise and compliance with some basic rules are needed to optimize clinical outcomes and minimize postoperative issues.

Florid histiocytic reaction to oxidized cellulose masquerading as ovarian malignancy: Report of two cases.

Bioabsorbable hemostatic agents like oxidized regenerated cellulose (ORC) are widely used in surgical practice. Rarely, adverse events due to retained ORC may occur and can pose a diagnostic dilemma. The unique tissue response to ORC may be misdiagnosed as signet ring type of adenocarcinoma. This article aims to highlight this rare phenomenon. We report two such cases involving the ovaries. Both the patients presented with ovarian cysts and tubo-ovarian adhesions 1-2 years following surgery for benign ovarian pathology. The present biopsies were featured by sheets of large cells with abundant vacuolated cytoplasm and often small peripherally displaced nuclei having "signet ring" appearance. These cells were negative for pan-cytokeratin and strongly positive for CD68, indicating the histiocytic nature of the cells. It was confirmed that in both the patients, at the time of the initial surgeries, hemostasis was ensured by packing with ORC.

Diagnóstico mediante EBUS-TBNA de reacción granulomatosa secundaria a Surgicel en adenopatía mediastínica / EBUS-TBNA diagnosis of a granulomatous reaction to Surgicel in mediastinal adenopathy

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A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery.

BACKGROUND/PURPOSE: Rapid hemostasis, an essential prerequisite of good surgical practice during surgical bleeding, including soft tissue open surgery, often requires adjunctive treatment. We evaluated the safety and hemostatic effectiveness of a human plasma-derived fibrin sealant (FS Grifols) in soft tissue open surgery. METHODS: Patients with moderate soft tissue bleeding during open, urologic, gynecologic or general surgery were studied. The trial consisted of a preliminary phase (to familiarize investigators with the technique for FS Grifols application and the intraoperative procedures required by the clinical protocol) and a primary phase: in both phases, patients were randomized 1:1 to FS Grifols or Surgicel®. The primary efficacy endpoint, based on analysis of subjects in the primary phase of the study, was to evaluate whether FS Grifols was non-inferior to Surgicel® in achieving hemostasis, based on the proportion of subjects in both treatment groups who achieved hemostasis at the target bleeding site (TBS) by 4 min (T4) following the start of treatment application. Safety assessments included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests, viral markers, and immunogenicity. RESULTS: A total of 224 subjects were randomized (primary phase): FS Grifols (N = 116), Surgicel® (N = 108). The 95% CI at T4 for the ratio of the proportion of patients achieving hemostasis in the two treatment groups was 1.064 (0.934, 1.213), indicating non-inferiority for FS Grifols vs. Surgicel®. The rate of hemostasis at the TBS by T4 in both phases of the study was higher in the FS Grifols treatment group (preliminary phase: 90.2%; primary phase: 82.8%) than in the Surgicel® treatment group (preliminary phase: 78.8%; primary phase: 77.8%). Overall, reported AEs were as expected in surgical patients and were similar between the two treatment groups. CONCLUSIONS: This study shows the non-inferiority in time to hemostasis of FS Grifols vs. Surgicel as an adjunct to hemostasis in patients undergoing soft tissue open surgery, and a similar rate of AEs.

FNA cytology of postoperative pseudotumoral lesions induced by oxidized cellulose hemostatic agents.

BACKGROUND: The use of topically applied hemostatic substances during surgery has become a common practice. In some cases, the material is not absorbed or induces a granulomatous reaction resulting in a pseudotumoral lesion. With imaging studies, it is not possible to differentiate this from a tumor recurrence or abscess. This study describes the authors' cytologic experience with a large series of pseudotumoral lesions induced by oxidized cellulose, one of the most commonly used hemostatic agents. Almost no cytologic descriptions are available in the medical literature. METHODS: Sixteen patients were evaluated, and the most common sites of fine-needle aspiration (FNA) were the mediastinum and thyroid surgical bed. Other locations were the axilla, neck, vulva, liver, and retroperitoneum. All these lesions appeared after surgical procedures in which oxidized cellulose was used as a topical hemostatic agent. The interval time between surgery and FNA varied from 4 to 46 months with a mean of 15 months. RESULTS: Cytology samples showed very similar findings. In all cases, foreign-body material with a variable granulomatous reaction was present. Oxidized cellulose was seen as laminated inorganic fragments and most often showed an elongated, quadrangular appearance. Amorphous, ill-defined fragments as well as a dense proteinaceous background with phagocytic cells were also present. CONCLUSIONS: The current study demonstrates that FNA cytology is a very useful method for the detection of pseudotumoral lesions induced by hemostatic agents. Pathologists must be familiarized with this finding because cytology permits easy differentiation from tumor recurrence.

Comparative study of four different types of intraperitoneal mesh prostheses in rats.

PURPOSE: To compare four types of mesh regarding visceral adhesions, inflammatory response and incorporation. METHODS: Sixty Wistar rats were divided into four groups, with different meshes implanted intraperitoneally: polytetrafluoroethylene (ePTFE group); polypropylene with polydioxanone and oxidized cellulose (PCD); polypropylene (PM) and polypropylene with silicone (PMS). The variables analyzed were: area covered by adhesions, incorporation of the mesh and inflammatory reaction (evaluated histologically and by COX2 immunochemistry). RESULTS: The PMS group had the lowest adhesion area (63.1%) and grade 1 adhesions. The ePTFE and PM groups presented almost the total area of their surface covered by adherences (99.8% and 97.7% respectively) The group ePTFE had the highest percentage of area without incorporation (42%; p <0.001) with no difference between the other meshes. The PMS group had the best incorporation rate. And the histological analysis revealed that the inflammation scores were significantly different. CONCLUSIONS: The PM mesh had higher density of adherences, larger area of adherences, adherences to organs and percentage of incorporation. ePTFE had the higher area of adherences and lower incorporation. The PMS mesh performed best in the inflammation score, had a higher incorporation and lower area of adherences, and it was considered the best type of mesh.

Internal surgical use of biodegradable carbohydrate polymers. Warning for a conscious and proper use of oxidized regenerated cellulose.

Oxidized regenerated cellulose has become a major local surgical hemostatic biomaterial because of its ease of use, favorable biocompatibility, bactericidal activity and bioabsorption characteristics. Additional clinical indications of oxidized regenerated cellulose include wound repair and tissue reconstruction. Sometimes, some unusual adverse events are described. Studies report cases of minor postoperative complications as nidus of infection or allergic reaction mainly presenting as acute dermatitis, eczema and sieroma. Also, rare and serious cases of foreign body reaction or impingement on nerve, due to not optimal bioabsorption, are showed in various surgical sites. Thus, on the one hand, patients should be informed by their clinicians of the possibility of these low incidence postoperative complications when considering preparations made of cellulose derivatives; and the clinicians should clearly indicate use of this biomaterial in the surgical procedure report so that radiologists may appropriately interpret any unusual findings potentially associated with this biomaterial use and thus avoid misdiagnosis and undue alarm in the follow-up of patients. On the other hand, the biomedical carbohydrate scientist must consider effective experimental design that substantially addresses the clinical adverse events associated with carbohydrate polymer use. Optimal development of carbohydrates for clinical use depends on excellent clinician/biomedical scientist communication.

Comparative study of four different types of intraperitoneal mesh prostheses in rats

Abstract Purpose: To compare four types of mesh regarding visceral adhesions, inflammatory response and incorporation. Methods: Sixty Wistar rats were divided into four groups, with different meshes implanted intraperitoneally: polytetrafluoroethylene (ePTFE group); polypropylene with polydioxanone and oxidized cellulose (PCD); polypropylene (PM) and polypropylene with silicone (PMS). The variables analyzed were: area covered by adhesions, incorporation of the mesh and inflammatory reaction (evaluated histologically and by COX2 immunochemistry). Results: The PMS group had the lowest adhesion area (63.1%) and grade 1 adhesions. The ePTFE and PM groups presented almost the total area of their surface covered by adherences (99.8% and 97.7% respectively) The group ePTFE had the highest percentage of area without incorporation (42%; p <0.001) with no difference between the other meshes. The PMS group had the best incorporation rate. And the histological analysis revealed that the inflammation scores were significantly different. Conclusions: The PM mesh had higher density of adherences, larger area of adherences, adherences to organs and percentage of incorporation. ePTFE had the higher area of adherences and lower incorporation. The PMS mesh performed best in the inflammation score, had a higher incorporation and lower area of adherences, and it was considered the best type of mesh.

A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections.

BACKGROUND: Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. METHODS: In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T4) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T2, T3, T5, T7, and T10. RESULTS: The rate of hemostasis by T4 was 92.8% in the FS Grifols group (n = 163) and 80.5% in the Surgicel® group (n = 162) (p = 0.01). The mean TTH was significantly shorter (p < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T2, T5, and T7 was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%). CONCLUSIONS: FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.

Practical Suggestions for Prevention of Complications Arising from Oxidized Cellulose Retention: A Case Report and Review of the Literature.

BACKGROUND Bleeding is a major intraoperative complication during surgical procedures. When conventional methods such as ligature and diathermocoagulation are ineffective for bleeding management, hemostatic agents should be used. Oxidized cellulose is one of the major hemostatic agents used worldwide. Oxidized cellulose is often left in situ after hemostasis because of its high level of reabsorption that lasts up to 8 weeks. However, 38 cases of retaining-associated complications are reported in the literature. CASE REPORT A 51-year-old male patient presented in our emergency department with acute abdominal pain, nausea, and vomiting. The patient had been admitted in our department for laparoscopic cholecystectomy for acute cholecystitis 25 months previously. Abdominal ultrasound and CT scan showed the presence of a cystic circular mass, with homogeneous fluid content, close to the surgical clips of the previous surgery, resembling a "neogallbladder". Laparoscopic abdominal exploration and drainage were performed. Histological examination reported protein-based amorphous material with rare lymphocytes and macrophages. Culturing was negative for bacterial growth. The patient was discharged uneventfully on the 4 th postoperative day. The primary surgical report was evaluated with evidence of application of Gelita-Cel ® Standard for hemostatic purposes. Results of 12-month follow-up were normal. CONCLUSIONS Herein, we report the first case of a complication associated with the use of Gelita-Cel ® Standard. We reviewed the literature to better define the purpose and limits of oxidized cellulose use as a hemostatic agent. Despite the fundamental role of oxidized cellulose as a hemostatic agent, we provide some practical suggestions to prevent the reported severe complications and surgical overtreatments.

Oxidized resorbable cellulose (Gelita-cel) causing foreign body reaction in the mediastinum.

Different types of oxidized cellulose have been used for haemorrhage control in thoracic surgery, abdominal surgery and neurosurgery. Oxidized resorbable cellulose (Gelita-cel) is a new haemostatic agent. Once saturated with blood, it swells and makes a gelatinous mass that formats as a fibrin clot. We have performed a prospective observational cohort study of patients operated for lung cancer or suspected lung cancer using Gelita-cel as a haemostatic agent. Between October 2010 and April 2012, 477 patients were operated in our department for lung cancer. Gelita-cel was used in 200 patients due to minor intraoperative haemorrhage after lymph node resection from Stations 2 to 11. During follow-up for lung cancer, computed tomography, which was performed 4-60 months after the primary operation, showed enlarged lymph nodes in the mediastinum in 16 patients. Endoscopic bronchial ultrasonographic biopsies of the lymph nodes showed foreign body material and granulomatous inflammation, and no sign of lung cancer recurrence. Gelita-cel has a high risk of causing granuloma and should not be used as a haemostatic agent in thoracic surgery.

Surgicel® packing remnants mimicking mediastinitis after adult cardiac surgery.

Surgicel® is one of the most commonly used bioabsorbable topical haemostatic agents. Some articles have reported that Surgicel® remnants might be misdiagnosed as an abscess. However, the number of reports in the cardiothoracic surgical field is limited. Herein, we report a 65-year-old woman who was suspected of having mediastinitis on computed tomography after redo-Bentall operation. Reoperation revealed that internal accumulation of Surgicel® remnants mimicked mediastinitis. It is important to share the use and location of Surgicel® with radiologists. If mediastinitis cannot be ruled out, the next step of reoperation or magnetic resonance imaging should be promptly taken.

Subhepatic mass occurrence after using oxidized and regenerated cellulose polymer in laparoscopic cholecystectomy: a case series.

BACKGROUND: Oxidized regenerated cellulose (ORC) is a bioabsorbable surgical hemostatic. We present the first prospective case series of circumscribed mass occurrence after using ORC in laparoscopic cholecystectomy. METHODS: Tabotamp (Ethicon, Inc., Somerville, NJ) in the form of tightly woven knitted patches was used to achieve hemostasis in 83 patients submitted to LC. RESULTS: A subhepatic mass was detected in five patients and radiologic characteristics were described. Abdominal contrast enhanced CT showed a heterogeneous soft-tissue mass. NMR was performed in one patient and showed a T2-weighted hyperintense mass. CONCLUSION: ORC retention after surgery is not uncommon at long-term follow-up. The radiologic characteristics of a suspected ORC retention mass can differentiate it from a neoplastic lesion, so that surgery can be avoided.

The Effectiveness of Oxidized Regenerated Cellulose as a Graft Material in Transalveolar Osteotome Sinus Lift Procedure.

The posterior maxilla is challenged with postextraction alveolar bone resorption and pneumatization drive of the Schneiderian membrane that reduces the subantral distance. To overcome such anatomic obstacle a sinus augmentation procedure was introduced either via lateral or crestal approach depending on residual ridge height. The current study evaluated oxidized regenerated cellulose (ORC) as a grafting material versus osteon II by measuring bone gain and graft density, 24 weeks postoperatively. Twenty consecutive patients (24 cases) aged from 20 to 65 years were considered eligible after clinical and radiographic evaluation. These patients were allocated in 2 groups (study and control) that underwent transcrestal osteotome antral membrane balloon elevation and surgical void augmentation with ORC in the study group, while the control group grafted with collagen membrane and osteon II with simultaneous dental implant placement in both groups and were followed up for 1 year. Cone beam computed tomography was taken for all patients preoperatively and postoperatively to verify neoformed bone and density in Hounsfield units (HU). The mean gained height of the bone was 6.48 mm (5.94 mm in the study and 7.02 mm in the control). The mean density of graft above implant apex was 497.99 HU (434.23 HU in the study and 561.75 HU in the control). Apart from Schneider membrane thickening in 2 patients from the control group, there were no serious complications reported throughout the study. These results demonstrate that ORC is a reasonable grafting material with comparable outcomes when compared to osteon II with less postoperative complications.

An Outbreak of Surgical Site Infections in A Neurosurgical Ward.

Objective To survey an outbreak of surgical site infections in a neurosurgery ward of a tertiary hospital. Methods The patients of surgical site infection were investigated individually based on a uniformly designed epidemiological survey form. The distribution of cases was analyzed by characteristic epidemiology,and a case-control study was carried to explore the risk factors. Results A total of 9 patients with surgical site infections from February 5 to March 7,2014 were identified in 68 patients who had received surgery in a neurosurgery ward,yielding a prevalence of 13.24%. The infections occurred in 7 of 14 patients who had used surgicel,a hemostatic agent,and in 2 of 54 patients who had not used surgicel. (χ2=16.637,P<0.001). Conclusion The use of surgicel may be the cause of this surgical site infection outbreak.

Reduction of postoperative adhesion development.

Despite use of meticulous surgical techniques, and regardless of surgical access via laparotomy or laparoscopy, postoperative adhesions develop in the vast majority of women undergoing abdominopelvic surgery. Such adhesions represent not only adhesion reformation at sites of adhesiolysis, but also de novo adhesion formation at sites of surgical procedures. Application of antiadhesion adjuvants compliment the benefits of meticulous surgical techniques, providing an opportunity to further reduce postoperative adhesion development. Improved understanding of the pathophysiology of adhesion development and distinguishing variations in the molecular biologic mechanisms from adhesion-free peritoneal repair represent future opportunities to improve the reduction of postoperative adhesions. Optimization of the reduction of postoperative adhesions will likely require identification of unique, personalized approaches in each individual, representing interindividual variation in peritoneal repair processes.