Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market: Insights from an FDA Workshop on Orthopaedic Device-Related Infections.

ABSTRACT: Orthopaedic device-related infection is one of the most devastating complications in orthopaedic and trauma surgery. With increasing life expectancies as well as the lifelong risk of bacterial seeding on an implant, the prevention and treatment of device-related infection remains an important area for research and development. To facilitate information exchange and enhance collaboration among various stakeholders in the orthopaedic community, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) organized an inaugural workshop on orthopaedic device-related infections, exploring the regulatory challenges that are faced when proceeding from the bench level to marketing and clinical implementation of new infection-control devices and products. This article summarizes the perspectives of scientists, clinicians, and industry partners on the current regulatory approval process for orthopaedic anti-infective technologies as well as the proposed strategies to overcome these regulatory challenges.

In vivo deformation of anatomically pre-bent rods in thoracic adolescent idiopathic scoliosis.

Some surgical strategies can maintain or restore thoracic kyphosis (TK); however, next-generation surgical schemes for adolescent idiopathic scoliosis (AIS) should consider anatomical corrections. A four-dimensional correction could be actively achieved by curving the rod. Thus, anatomically designed rods have been developed as notch-free, pre-bent rods for easier anatomical reconstruction. This study aimed to compare the initial curve corrections obtained using notch-free rods and manually bent, notched rods for the anatomical reconstruction of thoracic AIS. Two consecutive series of 60 patients who underwent anatomical posterior correction for main thoracic AIS curves were prospectively followed up. After multilevel facetectomy, except for the lowest instrumented segment, either notch-free or notched rods were used. Patient demographic data, radiographic measurements, and sagittal rod angles were analyzed within 1 week after surgery. Patients with notch-free rods had significantly higher postoperative TK than patients with notched rods (P < .001), but both groups achieved three-dimensional spinal corrections and significantly increased postoperative rates of patients with T6-T8 TK apex (P = .006 for notch-free rods and P = .008 for notched rods). The rod deformation angle at the concave side was significantly lower in the notch-free rods than in the notched rods (P < .001). The notch-free, pre-bent rod can maintain its curvature, leading to better correction or maintenance of TK after anatomical spinal correction surgery than the conventional notched rod. These results suggest the potential benefits of anatomically designed notch-free, pre-bent rods over conventional, manually bent rods.

Bacteriophage therapy for bone and joint infections.

Antibiotic resistance represents a threat to human health. It has been suggested that by 2050, antibiotic-resistant infections could cause ten million deaths each year. In orthopaedics, many patients undergoing surgery suffer from complications resulting from implant-associated infection. In these circumstances secondary surgery is usually required and chronic and/or relapsing disease may ensue. The development of effective treatments for antibiotic-resistant infections is needed. Recent evidence shows that bacteriophage (phages; viruses that infect bacteria) therapy may represent a viable and successful solution. In this review, a brief description of bone and joint infection and the nature of bacteriophages is presented, as well as a summary of our current knowledge on the use of bacteriophages in the treatment of bacterial infections. We present contemporary published in vitro and in vivo data as well as data from clinical trials, as they relate to bone and joint infections. We discuss the potential use of bacteriophage therapy in orthopaedic infections. This area of research is beginning to reveal successful results, but mostly in nonorthopaedic fields. We believe that bacteriophage therapy has potential therapeutic value for implant-associated infections in orthopaedics. Cite this article: Bone Joint J 2021;103-B(2):234-244.

The influence of duration of infection on outcome of debridement and implant retention in fracture-related infection.

AIMS: The principle strategies of fracture-related infection (FRI) treatment are debridement, antimicrobial therapy, and implant retention (DAIR) or debridement, antimicrobial therapy, and implant removal/exchange. Increasing the period between fracture fixation and FRI revision surgery is believed to be associated with higher failure rates after DAIR. However, a clear time-related cut-off has never been scientifically defined. This systematic review analyzed the influence of the interval between fracture fixation and FRI revision surgery on success rates after DAIR. METHODS: A systematic literature search was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, in PubMed (including MEDLINE), Embase, and Web of Science Core Collection, investigating the outcome after DAIR procedures of long bone FRIs in clinical studies published until January 2020. RESULTS: Six studies, comprising 276 patients, met the inclusion criteria. Data from this review showed that with a short duration of infection (up to three weeks) and under strict preconditions, retention of the implant is associated with high success rates of 86% to 100%. In delayed infections with a fracture fixation-FRI revision surgery interval of three to ten weeks, absence of recurrent infection was reported in 82% to 89%. Data on late FRIs, with a fracture fixation-FRI revision surgery interval of more than ten weeks, are scarce and a success rate of 67% was reported. CONCLUSION: Acute/early FRI, with a short duration of infection, can successfully be treated with DAIR up to ten weeks after osteosynthesis. The limited available data suggest that chronic/late onset FRI treated with DAIR may be associated with a higher rate of recurrence. Successful outcome is dependent on managing all aspects of the infection. Thus, time from fracture fixation is not the only factor that should be considered in treatment planning of FRI. Due to the heterogeneity of the available data, these conclusions have to be interpreted with caution. Cite this article: Bone Joint J 2021;103-B(2):213-221.

Evaluation of complications in patients with open fractures of the upper and lower extremity treated with internal fixation after the external fixation.

BACKGROUND: Open fractures constitute an important mortality and morbidity cause among all musculoskeletal system injuries and bring along many social and economic problems. The cost occurring due to both long treatment duration and the delay in returning to work made these conditions more complicated. The present study aims to evaluate of the complications which may occur in cases with an application of internal fixation following external fixator in upper and lower extremity open fractures retrospectively. METHODS: Forty-nine patients, who applied to the emergency service between 2007 and 2013, participated in this study. Thirty-two of these patients consisted of the patients to whom external fixator was first placed, and then internal fixation was performed by us, while 17 patients were treated in another center with the external fixator, and then their treatments were performed by us. All patients' injury mechanism, duration of follow-up with an external fixator, whether debridement was performed after external fixator, the period between external fixation and internal fixation, pin site infection, duration of the union, delayed union, nonunion, whether bone graft was used during internal fixation, internal fixation type, reoperation, development of osteomyelitis and follow-up parameters were recorded. RESULTS: Results were evaluated separately for radius, humerus, tibia and femur fractures. Of the 49 patients, 39 were male, and 10 were female. Mean follow-up time for tibia 28.6 months, for femur 34, for humerus 26.9, for Radius 27 months. Of the 49 patients who participated in this study, 15 applied with upper extremity (11 humeri, 4 Radius) injury and 34 applied with lower extremity (25 tibias, 9 femora) injury. Of the 49 patients, 32 had pin tract infection, 11 had nonunion, 11 had delayed union, two had osteomyelitis. CONCLUSION: Open fractures are always hard to treat. After external fixation to the internal fixation process have some complications, phsycians should be aware of all these problems and plan according to the situation.

Anterior Vertebral Body Growth-Modulation Tethering in Idiopathic Scoliosis: Surgical Technique.

The management of idiopathic scoliosis in the skeletally immature patient can be challenging. Posterior spinal fusion and instrumentation is indicated for severe scoliosis deformities. However, the skeletally immature patient undergoing posterior fusion and instrumentation is at risk for developing crankshaft deformities. Moreover, bracing treatment remains an option for patients who are skeletally immature, and although it was found to be effective, it does not completely preclude deformity progression. Recently, fusionless treatment options, such as anterior vertebral body growth modulation, have been developed to treat these patients while avoiding the complications of posterior rigid fusion. Good results have been shown in recent literature with proper indications and planning in the skeletally immature patient.

The NuVasive MAGEC Rod Urgent Field Safety Notice Concerning Locking Pin Fracture: How Does Data From an Independent Explant Center Compare?

STUDY DESIGN: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods. OBJECTIVE: The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data. SUMMARY OF BACKGROUND DATA: On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred. METHODS: From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer. RESULTS: One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter. CONCLUSION: Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer. LEVEL OF EVIDENCE: 4.

Medial malleolar fractures: current treatment concepts.

The medial malleolus, once believed to be the primary stabilizer of the ankle, has been the topic of conflicting clinical and biomechanical data for many decades. Despite the relevant surgical anatomy being understood for almost 40 years, the optimal treatment of medial malleolar fractures remains unclear, whether the injury occurs in isolation or as part of an unstable bi- or trimalleolar fracture configuration. Traditional teaching recommends open reduction and fixation of medial malleolar fractures that are part of an unstable injury. However, there is recent evidence to suggest that nonoperative management of well-reduced fractures may result in equivalent outcomes, but without the morbidity associated with surgery. This review gives an update on the relevant anatomy and classification systems for medial malleolar fractures and an overview of the current literature regarding their management, including surgical approaches and the choice of implants. Cite this article: Bone Joint J 2019;101-B:512-521.

Rationale and Options for Choosing an Optimal Closure Technique for Primary Midsagittal Osteochondrotomy of the Sternum, Part 2: A Theoretical and Critical Review of Techniques and Fixation Devices.

The intact one-piece sternum is indispensible to the thorax for its normal physiological biomechanics. To overcome tri-planar forces acting on the sternum following midsagittal osteochondrotomy, it must be reconstructed using an optimal technique to withstand distraction loads of normal respiration and violent cough. It should be fixed rigidly to reconstitute the anterior coronal column of the axial skeleton to maintain erect posture and prevent kyphosis. Sterile or infective non-union of the sternum compromises the physical endurance of patients and has an immense psychological effect. From an engineering perspective, there is no substantially proven gold standard technique to fix a divided sternum. Stainless steel wire applied in various configurations to a variety of shapes and sizes has become an acceptable standard of care due to its long-standing history and cost-effectiveness. Recently there has been a proliferation of innovative techniques to deal with primary and failed union of the sternum in an effort to prevent mechanical failure and serious deep surgical wound infection progressing to mediastinitis. Among the newer implant designs, the ones currently in use are shaped like clamps and clasps to compress the sternal halves together as well as alphabet-shaped mini-plating systems. In this section of the review series, mechanisms, pros and cons of currently available implants to reconstruct the bisected sternum, and external support systems considered necessary in high-risk clients are discussed.

Colocación de Endobutton intraarticular posterior a plástica de ligamento cruzado anterior / Intra-articular migration of Endobutton fixation following ACL reconstruction

La ruptura del ligamento cruzado anterior es una patología frecuente en deportistas, siendo la reconstrucción del mismo uno de los procedimientos más frecuentes en la cirugía ortopédica. Se han descripto múltiples técnicas quirúrgicas, con distintos injertos y sistemas de fijación. Si bien la fijación femoral es controvertida, el sistema de fijación suspensoria con Endobutton demostró tener una fuerza biomecánica mayor que la de los tornillos interferenciales. La migración intraarticular del Endobutton es una complicación infrecuente que ha sido descripta previamente en la literatura. Presentamos el caso de un paciente masculino de 24 años de edad, con una migración intraarticular del Endobutton posterior a una plástica del ligamento cruzado anterior de cuatro meses de evolución

The anterior cruciate ligament (LCA) ruptures are a frequent pathology in athletes, being the reconstruction one of the most frequent procedures in orthopedic surgery. Many surgical techniques have been described, with different grafts and fixation systems. Although femoral fixation is controversial, the suspensory fixation system with Endobutton have demonstrated a greater biomechanical force in comparison with interferential screws. The intra-articular migration of Endobutton is an infrequent complication that has been previously described in the literature. We present a 24 years male patient, with an intraarticular migration of the Endobutton posterior LCA reconstruction of four months of evolution. Two stage revision ACL reconstruction were performed modifying the fixation method to a bone patellar bone graft

Staged distraction osteogenesis followed by arthrodesis using internal fixation as a form of surgical treatment for complex conditions of the ankle.

Aims: The aim of this study was to describe the technique of distraction osteogenesis followed by arthrodesis using internal fixation to manage complex conditions of the ankle, and to present the results of this technique. Patients and Methods: Between 2008 and 2014, distraction osteogenesis followed by arthrodesis using internal fixation was performed in 12 patients with complex conditions of the ankle due to trauma or infection. There were eight men and four women: their mean age was 35 years (23 to 51) at the time of surgery. Bone healing and functional recovery were evaluated according to the criteria described by Paley. Function was assessed using the ankle-hindfoot scale of the American Orthopedic Foot and Ankle Society (AOFAS). Results: A solid fusion of the ankle and eradication of infection was achieved in all patients. A mean lengthening of 6.1 cm (2.5 to 14) was achieved at a mean follow-up of 25.2 months (14 to 37). The mean external fixation index (EFI) was 42 days/cm (33.3 to 58). The function was judged to be excellent in six patients and good in six patients. Bone results were graded as excellent in ten patients and good in two patients. The mean AOFAS score was 37.3 (5 to 77) preoperatively and 75.3 (61 to 82) at the final follow-up. Minor complications, which were treated conservatively, included pain, pin-tract infection, loosening of wires, and midfoot stiffness. Major complications, which were treated surgically included grade V pin-tract infection with inflammation and osteolysis, poor consolidation of the regenerate bone, and soft-tissue invagination. The reoperations required to treat the major complications included the exchange of pins and wires, bone grafting and invagination split surgery. Conclusion: The technique of distraction osteogenesis followed by arthrodesis using internal fixation is an effective form of treatment for the management of complex conditions of the ankle. It offers a high rate of union, an opportunity to remove the frame early, and a reduced EFI without infection or wound dehiscence. Cite this article: Bone Joint J 2018;100-B:755-60.

Outcomes of growing rod surgery for severe compared with moderate early-onset scoliosis: a matched comparative study.

Aims: The aim of this study was to compare the outcomes of surgery using growing rods in patients with severe versus moderate early-onset scoliosis (EOS). Patients and Methods: A review of a multicentre EOS database identified 107 children with severe EOS (major curve ≥ 90°) treated with growing rods before the age of ten years with a minimum follow-up of two years and three or more lengthening procedures. From the same database, 107 matched controls with moderate EOS were identified. Results: The mean preoperative major curve was 101° (90 to 139) in the severe group and 67° (33° to 88°) in the moderate group (p < 0.001), which was corrected at final follow-up to 57° (10° to 96°) in the severe group and 40° (3° to 85°) in the moderate group (p < 0.001). T1-S1 height increased by a mean of 54 mm (-8 to 131) in the severe group and 27 mm (-4 to 131) in the moderate group at the initial surgery (p < 0.001), and by 50 mm (-17 to 200) and 54 mm (-11 to 212), respectively, during distraction (p = 0.84). The mean number of complications per patient was 2.6 (0 to 14) in the severe group and 1.9 (0 to 10) in the moderate group (p = 0.040). Five patients (4.7%) in the severe group and three (2.8%) in the moderate group developed a neurological deficit postoperatively (p = 0.47). Conclusion: Severe EOS can be treated effectively using growing rods, but the risk of complications is high. Cite this article: Bone Joint J 2018;100-B:772-9.

Surgical considerations with the operative fixation of unstable paediatric pelvic ring injuries.

INTRODUCTION: The operative treatment of unstable pelvic injuries in paediatrics is not frequently indicated. The detailed modes of pelvic ring failure, surgical techniques, fixation choices, and peri-operative difficulties are not well reported. METHODS: From September 2010 to March 2016, 62 paediatric patients were admitted to an academic level I trauma center with the diagnosis of pelvic ring injury. Of them, 29 (17 males and 12 females) had operative fixation of unstable pelvic injuries. Their average age was 11.7 ± 4.4 years. RESULTS: There were six Tile's B injuries and 23 type C injuries. The commonest modes of pelvic ring failure were pubic rami fractures anteriorly and ligamentous sacroiliac joint injuries posteriorly. The iliac apophysis was avulsed in nine patients. Supra-acetabular external fixators were frequently used for anterior fixation while iliosacral IS screws and lateral compression LC screws were commonly used posteriorly. Difficulties were encountered with open reduction and repair of avulsed iliac apophyses in two patients. The IS screws pierced the soft iliac wing in three patients. In two patients with open triradiate cartilage, the purchase of retrograde LC screws was weak due the small sized crescent fragment. CONCLUSION: The iliac apophysis needs to be repaired following reduction of the displaced hemipelvis. Anterior supra-acetabular external fixation is a good choice in paediatrics even with pubic symphysis diatasis as the pathology is commonly a pubic apophysis avulsion. IS screws might be inserted through plates to prevent piercing the soft iliac wing. Retrograde LC screws should be avoided in young children.

Comparison of intramedullary nail, plate, and external fixation in the treatment of distal tibia nonunions.

PURPOSE: The purpose of this study was to examine time to union of extra-articular distal tibia nonunions based on fracture type and fixation methods: intramedullary nail (IMN), plate osteosynthesis (PO), and external fixation (EF). METHODS: This retrospective chart review included all patients who presented at a Level I trauma center with AO/OTA 43A & distal third 42A-C fracture nonunions between 2008 and 2014. Fixation methods were recorded and patient course was followed until nonunion had healed clinically. RESULTS: Thirty-three distal tibia nonunions were included, and 29 reached eventual union (88%). Five AO/OTA fracture types were present. Mean times to union from nonunion diagnosis between original fracture types were compared (p = 0.203). Comminuted fracture types had longer times to union from nonunion diagnosis compared to simple fracture types (78 vs. 46 weeks, p = 0.051) and more revision fixations (1.5 vs. 0.5, p = 0.037). Mean time to union from nonunion diagnosis was shorter when no revision fixation was done compared to revisions (15 vs. 42 weeks, p = 0.102). Times to union from nonunion diagnosis without revision fixation were: IMN (12 weeks), PO (27 weeks), and EF (13 weeks) (p = 0.202). Times to union from definitive revision fixation were: IMN (17 weeks), PO (21 weeks), and EF (66 weeks) (p = 0.009), with EF taking significantly longer than both other methods. 21 patients (64%) underwent revision fixation. Revision fail rates were: IMN (0/6, 0%), PO (2/8, 25%), and EF (15/21, 71%). Time to union was longer in revisions that changed fixation method compared to revisions that used the same method (51 vs. 18 weeks, p = 0.030). Deep infections were also associated with longer union times (81 vs. 47 weeks, p = 0.040). CONCLUSIONS: In this nonunion population, comminuted fracture types needed more time and revisions to reach union. Time to union was only clinically shorter when revision fixation was not performed, but IMN and PO were both successful fixation options with significantly shorter times to union than EF. Mean time to union increased even more when revision of fixation method was performed vs. exchange revision, as did nonunions with deep infections.

Corrective osteotomy of the distal femur with fixator assistance: A novel technique of minimally invasive osteosynthesis.

PURPOSE: Varus or valgus deformity of the distal femur may progress into knee osteoarthritis. To delay or prevent this, various types of corrective osteotomy techniques have been used to shift the mechanical axis from the diseased compartment to the healthy one. We introduced a new, minimally invasive osteotomy of the distal femur with the assistance of temporary external fixation. METHODS: We retrospectively studied 25 legs that underwent open-wedge osteotomy of the distal femur, involving insertion of a Schanz pin at the medial femoral condyle and another pin at the distal diaphysis of the femur. At the meta-diaphyseal junction, osteotomy was performed. After achieving angular correction, two pins were locked for temporary external fixation and a locking plate was fixed at the lateral side of the femur submuscularly. Radiological and functional outcomes were evaluated, including mechanical lateral distal femoral angle (m-LDFA), mechanical axis deviation, tibiofemoral angle, osseous union, and knee joint motion. RESULTS: The minimum follow-up was 12 months (mean, 39 months; range, 12-88 months). Bone healing occurred in all legs, with an average of 16.6 weeks. The m-LDFA was corrected from 77.7° (18 valgus) and 104.6° (7 varus) to 88.1° after surgery, with an average correction of 12.9°. At the final follow-up, the mechanical axis deviation averaged 7.6 mm and the tibia-femoral angle averaged 5.6°. Most of legs (88%) achieved acceptable m-LDFA (87° ± 3°). CONCLUSIONS: A new, minimally invasive osteotomy of the distal femur offers excellent bone healing with few complications, attributable to preserved blood supply.

Successful Treatment of Persistent Pain After Pectus Excavatum Repair Using Paravertebral Nerve Radiofrequency Thermoablation.

We present a case of a 25-year-old male patient suffering from severe prolonged pain after uneventful pectus excavatum repair that could be treated successfully by paravertebral nerve radiofrequency thermoablation. The patient was scheduled for a minimally invasive Nuss pectus excavatum repair. Surgical correction was performed under general anesthesia in combination with a thoracic peridural catheter. The immediate postoperative course was uneventful; however, the patient developed severe prolonged bilateral chest wall pain across segments T8 and T9. After failure of conservative treatment options, a specialized interventional anesthesiologist performed paravertebral nerve radiofrequency thermoablation of segment T9 bilaterally, after which the patient was pain free until scheduled removal of the pectus bar 3 years after placement.

[Orthognathic surgery: surgical failures and complications]. / Chirurgie orthognathique : échecs chirurgicaux et complications∗.

Orthognathic surgery procedures mark the endpoint of lengthy orthodontic-surgical preparations and herald the completion of treatment for patients and their families. The main types of procedure are full maxillary Le Fort I osteotomies, mandibular osteotomies and chin surgery. To ensure a successful outcome, all require a favorable environment and extreme technical skill. But, like all surgical operations, they are also subject to peri- and post-operative complications resulting from treatment hazards or errors. Whatever the cause, surgical complications can entail failures in the management of the malformation. By seeking to understand and analyzing these complications, we can already help to prevent and reduce the contingent risks of failure.

Prosthetic Joint and Orthopedic Device Related Infections. The Role of Biofilm in the Pathogenesis and Treatment.

Prosthetic joint infections (PJI) in orthopedic related devices (ORD) are major issues following replacement of joints. It results in serious morbidity and mortality and is expensive to treat and manage. The pathogenesis of these infections is related to the presence of biofilm on the metallic and plastic surfaces of the devices. This biofilm results in poor penetration of antibiotics resulting in persistence and difficulty in eradication of the infection despite appropriate antibiotics. This paper summarizes the present data of biofilm as it relates to PJI/ORD.

[EXOTHERMIC REACTIONS OF PLASTER IMMOBILIZATION ­ ANALYSIS OF THREE KINDS OF PLASTER BANDAGES].

Exothermic reaction of plaster is a very important characteristic to understand, especially when it comes to complications which can occur during local temperature change during molding plaster of Paris. And these complications directly influence the speed and quality of treatment. In this paper we measured temperatures of plaster bandage tiles 10×10 cm, from three different manufacturers in Croatian hospitals: Safix plus (Hartmann, Germany), Cellona (Lohmann &Rauscher, Austria) and Gipsan ( Ivo Lola Ribar, Croatia). We made three different plaster tiles 10×10 cm, from 10, 15 and 30 layers of plaster bandages. We immersed plaster tiles in two different water temperatures, one group in water 22 °C, and another in 34 °C. Although all plaster bandages have similar chemical characteristics, we have measured some differences. All three kinds of plaster bandages used in Croatia have low exothermic reaction when plaster molding is done in standard conditions, average local temperature is low and there is no danger of local burns. We immersed a plaster tile with 15 layers in water on 34° C, and highest average temperature was measured at Gipsan (46.2 °C), then Cellona (41.3 °C) and Safix plus (38.9 °C). On the same water immersion temperature, on plaster tile with 30 layers average temperatures were Gipsan (48.4°C), Cellona (45.4 °C), and lowest in Safix plus (41.3 °C). Plaster tiles form all manufacturers, when used 15-30 layers thick, and water immersion temperature is 34°C, develop average temperature over 40°C, in duration from 8-12 minutes. Between three different plaster bandages analyzed, Gipsan (Ivo Lola Ribar, Croatia) developed highest temperature, and some plaster tiles were measured over 50 °C.