Instant tough bioadhesive with triggerable benign detachment.

Bioadhesives such as tissue adhesives, hemostatic agents, and tissue sealants have potential advantages over sutures and staples for wound closure, hemostasis, and integration of implantable devices onto wet tissues. However, existing bioadhesives display several limitations including slow adhesion formation, weak bonding, low biocompatibility, poor mechanical match with tissues, and/or lack of triggerable benign detachment. Here, we report a bioadhesive that can form instant tough adhesion on various wet dynamic tissues and can be benignly detached from the adhered tissues on demand with a biocompatible triggering solution. The adhesion of the bioadhesive relies on the removal of interfacial water from the tissue surface, followed by physical and covalent cross-linking with the tissue surface. The triggerable detachment of the bioadhesive results from the cleavage of bioadhesive's cross-links with the tissue surface by the triggering solution. After it is adhered to wet tissues, the bioadhesive becomes a tough hydrogel with mechanical compliance and stretchability comparable with those of soft tissues. We validate in vivo biocompatibility of the bioadhesive and the triggering solution in a rat model and demonstrate potential applications of the bioadhesive with triggerable benign detachment in ex vivo porcine models.

Effect of Changing Surgical Instruments Before Wound Closure to Prevent Wound Infection in Lower GI Surgery: A Randomized Controlled Trial.

BACKGROUND: Surgical site infection is a major surgical complication and has been studied extensively. However, the efficacy of changing surgical instruments before wound closure remains unclear. OBJECTIVE: The aim of this study was to investigate the efficacy of changing surgical instruments to prevent incisional surgical site infection during lower GI surgery. DESIGN: This was a randomized controlled trial. SETTINGS: This study was conducted at the Hyogo College of Medicine in Japan. PATIENTS: Patients undergoing elective lower GI surgery with open laparotomy were included. INTERVENTIONS: Patients were randomly assigned to 1 of 2 groups. In group A, the surgeon changed surgical instruments before wound closure, and in group B, the patients underwent conventional closure. MAIN OUTCOME MEASURES: The primary end point was the incidence of incisional surgical site infection. The secondary end point was the incidence of surgical site infection restricted to clean-contaminated surgery. RESULTS: A total of 453 patients were eligible for this trial. The incidence of incisional surgical site infection was not significantly different between group A (18/213; 8.5%) and group B (24/224; 10.7%; p = 0.78). In the clean-contaminated surgery group, the incidence of incisional surgical site infection was 13 (6.8%) of 191 in group A and 9 (4.7%) of 190 in group B (p = 0.51). LIMITATIONS: This was a single-center study. CONCLUSIONS: Changing surgical instruments did not decrease the rate of incisional surgical site infection in patients undergoing lower GI surgery in either all wound classes or clean-contaminated conditions. See Video Abstract at http://links.lww.com/DCR/B701. EFECTO DE REALIZAR CAMBIO DE LOS INSTRUMENTOS QUIRRGICOS ANTES DEL CIERRE DE LA INCISIN EN LA INFECCIN DE LA HERIDA DEL SITIO QUIRRGICO EN CIRUGA DEL TUBO DIGESTIVO BAJO ESTUDIO ALEATORIO CONTROLADO: ANTECEDENTES:La infección del sitio quirúrgico es una complicación importante y se ha estudiado ampliamente. Sin embargo, la eficacia de cambiar los instrumentos quirúrgicos antes del cierre de la herida sigue sin estar clara.OBJETIVO:El objetivo de este estudio es investigar la eficacia de cambiar el instrumental quirúrgico en la prevención de la infección del sitio quirúrgico en cirugía gastrointestinal inferior.DISEÑO:Estudio aleatorio controlado.AJUSTE:Este estudio se realizó en la Facultad de Medicina de Hyogo en Japón.PACIENTES:Se incluyeron pacientes sometidos a cirugía electiva de tubo digestivo bajo con laparotomía abierta.INTERVENCIONES:Los pacientes fueron asignados aleatoriamente a uno de dos grupos. En el grupo A, el cirujano cambió el instrumental quirúrgico antes del cierre de la herida, y en el grupo B, los pacientes se sometieron a un cierre convencional.PRINCIPALES MEDIDAS DE RESULTADO:El criterio de valoración principal fue la incidencia de infección del sitio quirúrgico de la incisión. El criterio de valoración secundario fue la incidencia de infección del sitio quirúrgico restringida a la cirugía limpia contaminada.RESULTADOS:Un total de 453 pacientes fueron elegibles para este ensayo. La incidencia de infección del sitio quirúrgico no fue significativamente diferente entre el grupo A (18/213; 8,5%) y el grupo B (24/224; 10,7%) (p = 0,78). En el grupo de cirugía limpia-contaminada, la incidencia de infección del sitio quirúrgico incisional fue 13/191 (6,8%) en el grupo A y 9/190 (4,7%) en el grupo B (p = 0,51).LIMITACIÓN:Estudio de un solo centro.CONCLUSIÓNES:El cambio de instrumentos quirúrgicos no disminuyó la tasa de infección del sitio quirúrgico en todas las clases de heridas o condiciones limpias-contaminadas. Consulte Video Resumen en http://links.lww.com/DCR/B701.

Suture-Free Sealing of Tunical Defect with Collagen Fleece after Partial Plaque Excision in 319 Consecutive Patients with Peyronie's Disease: The Sealing Technique.

PURPOSE: We describe the sealing technique with collagen fleece in patients with advanced Peyronie's disease (PD) and provide the prospective long-term outcomes. MATERIALS AND METHODS: We performed a multicenter cohort study in patients with preserved erectile function and stable PD that precluded sexual intercourse. All patients underwent partial plaque excision with collagen fleece grafting. The applied technique is explained through a high-quality video accompanied by relevant animations. After hospital discharge, all patients were assessed at 1, 4 and 24 weeks after treatment. Subsequently, they presented for an additional long-term evaluation. RESULTS: From December 2004 to June 2015, 367 patients underwent surgery. Of these, 319 (86.9%) presented for the long-term evaluation and were included in the present study. At a median operative time of 79.8 minutes (range 50-130), total straightness of the penis was achieved in 299 cases (93.7%) and mean±SD penile length increased by 1.1±0.6 cm (p=0.017). After a median followup of 47.2 months (range 12-100), 291 patients (91.2%) presented with complete penile straightness. The penile glans sensation returned to the preoperative levels in 300 cases (94%). Only 11 cases of treatment-related grade 1 Clavien-Dindo complications were reported. Erectile function improved in 78 participants (24.5%) and remained unchanged in 191 (59.8%), whereas it was worsened in 50 (15.7%). Overall, the patient satisfaction rate was 87.8% and the partner satisfaction rate was 84.3%. CONCLUSIONS: Grafting with collagen fleece in patients with advanced PD is a safe and effective procedure that reduces operative time, provides an additional hemostatic effect and represents a cost-effective technique.

Neither Skin Sutures nor Foam Dressing Use Affect Tracheostomy Complication Rates.

BACKGROUND: Tracheostomy is commonly used for managing the airway of trauma patients. Complications are common and result in increased length of stays and treatment cost. The aim of this study is to evaluate whether the utilization of skin sutures or foam barrier dressings affect tracheostomy complication rates. MATERIALS AND METHODS: This is a single-center retrospective review of patients who underwent a tracheostomy by the trauma service between January 2014 and December 2017. Collected variables included demographics, patient history, treatment variables, complications, and outcomes. Univariate and multivariate analyses were constructed to identify significant predictors for the development of complications. RESULTS: A total of 268 patients were included. The median age was 43.5 y, 221 (82.5%) patients were men, and the median BMI was 28 (IQR 24.6, 32.2). Most (87.3%) of the procedures were performed in the operating room and 82.5% were open. Skin sutures were used in 46.3% and 53.4% had a foam barrier dressing placed. Current smoking [OR 8.1 (95% CI 1.5, 43.6)] and BMI [OR 1.1 (95% CI 1.03, 1.2)] significantly increased the risk of developing pressure necrosis. Use of sutures or foam dressings was not associated with pressure necrosis, bleeding, or surgical site infection. There were no unexpected tracheostomy decannulations regardless of the use of skin sutures. CONCLUSIONS: Suturing the tracheostomy or applying a foam barrier dressing was not associated with overall complications or decannulation rates. Based on our data, we suggest that skin sutures may be safely abandoned.

Intraoperative findings, complications, and short-term results after lumbar microdiscectomy with or without implantation of annular closure device.

BACKGROUND: Standard microscopic lumbar discectomy (MLD) is a short operation with minimal blood loss, and a low rate of peri- and intraoperative complications. The objective of this study was to evaluate intraoperative findings, complications, and early postoperative neurological outcome (< 105 days) in patients undergoing MLD with or without implantation of an annular closure device (ACD). METHODS: This study is based on data analysis of a post-marketing, prospective, multicenter RCT in Europe including patients undergoing standard MLD with or without implantation of an ACD (Barricaid®, Intrinsic Therapeutics, Inc., Woburn, MA). Enrollment of 554 patients in 21 centers in Europe (Germany, Switzerland, Austria, Belgium, The Netherlands, and France) started in 2010 and was completed in October 2014, with 276 patients randomized to the ACD group and 278 to the control group. RESULTS: Mean operation time was 70 min in the ACD group and 52 min in the control group (p < 0.0001). Intraoperative fluoroscopy time was 24 s in the ACD group and 7 s in the control group (p < 0.0001). Average blood loss was 94.2 ml in the ACD group and 64.7 ml in the control group (p = 0.0001). Serious device- or procedure-related adverse events occurred in 3.7% (10/272) of the ACD group and 7.9% (22/278) of the control group. Dural injuries occurred in 13 (4.8%) patients in the ACD group and 7 (2.5%) in the control group. There was one device-related nerve root injury resulting in a nerve root amputation. Surgical complications included 3 hematomas in the ACD group and 4 in the control group; 3 infections occurred in both groups. Device migrations were documented in 3 patients in the ACD group. Patients in the ACD group (n = 7, 2.6%) underwent fewer reoperations compared with that in the control group (n = 16, 5.8%, OR = 2.3 (0.9-5.7)). Mean VAS leg pain at 3 months was 11.9 in the ACD and 15.1 in the control group, respectively. CONCLUSION: Short-term outcome after MLD with or without implantation of ACD was similar in both groups. Patients included in the ACD group underwent fewer reoperations in the first 3 months after surgery. Nevertheless, longer operation time, higher amount of blood loss, and risk of nerve root lesion during device implantation should be considered additional risks in patients undergoing ACD implantation after MLD.

Interlocking Multi-Twisted Wires Versus Interrupted Simple Sternal Wires for Closure of Median Sternotomy.

BACKGROUND: Although closure of a sternotomy incision is usually a simple procedure, failure to do so (sternal dehiscence) is a serious complication and is an independent factor that poses a high degree of morbidity or mortality after open heart surgery. Instability of the bone fragments can lead to complete sternal breakdown, sternal wound infection, and mediastinitis. The stainless-steel encircling wire used as either interrupted simple sutures or as figure of eight sutures is the current standard method of median sternotomy closure. Interlocking multi-twisted sternal wire closure is an alternative that provides rigid sternal fixation. We aim to identify the best method of sternal closure in order to implement it as a standardised protocol for our department. METHODS: Two-hundred patients aged 18-70 years were undergoing cardiac surgeries at Ain Shams University hospitals. They were divided into two groups: Group I included 100 patients with sternal closure using simple wire, and group II included 100 patients with sternal closure using interlocking multi-twisted wires. The day 7, 1 month, and 3 months sternal instability, superficial wound infection, ventilation time, cross-clamp time, length of ICU stay, and length of hospital stay were analyzed. RESULTS: The incidence of sternal instability on the 7th day, 1 month, and 3 months was significantly higher in the simple wire closure group (P < 0.05). However, incidence of superficial wound infection, length of ICU stay, and duration of mechanical ventilation were comparable between the two groups. CONCLUSION: The interlocking multi-twist is a safe, effective, and easily reproducible method for preventing sternal dehiscence.

Clip-on-clip closure method for a mucosal defect after colorectal endoscopic submucosal dissection: a prospective feasibility study.

BACKGROUND: The closure of mucosal defects after colorectal endoscopic submucosal dissection (ESD) remains difficult. Therefore, various methods and devices have been developed to aid in this procedure. However, a standard method for mucosal defect closure after ESD has not been established. We aimed to examine the efficiency and safety of our clip-on-clip closure method (CCCM) after colorectal ESD. METHODS: The CCCM is a novel method for colorectal mucosal defect closure that uses a conventional clip on the handle of another clip, with the gap as an anchor. The CCCM was prospectively used for closing mucosal defects in 30 patients with 32 lesions after colorectal ESD at the Japanese Ise Red Cross Hospital, Yokkaichi Municipal Hospital, and Medical Corporation Yamashita Hospital between March 2018 and July 2018. Outcome measures were closure success rates of CCCM, procedural closure time, and postoperative adverse events. RESULTS: The median resected specimen size was 34 mm (range 28-73 mm) and the median CCCM defect closure success rate was 97% (31/32). The median procedural time was 8 min (range 3.5-29.2 min), and the median number of clips used was 12 pieces (range 5-20). None of the patients had postoperative adverse events. CONCLUSIONS: CCCM is an efficient, safe, and simple method for the closure of mucosal defects after colorectal ESD that can be performed using only conventional clips.

Over-the-scope clip-assisted endoscopic full thickness resection: a video-based case series.

BACKGROUND: In the management of mucosal neoplasm and early cancer, therapeutic gastrointestinal endoscopy evolved from simply polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection (ESD), to endoscopic full thickness resection (EFTR). Full thickness clip closure followed by transmural resection mimics surgical principles. It is safe, effective, and technically less demanding compared to other techniques. Over-the-scope clip (OTSC)-assisted EFTR or OTSC-EFTR enables the endoscopists to manage difficult lesions. METHODS: We video recorded and report our 1-year single center experience of 12 consecutive EFTR cases since the dedicated OTSC-EFTR device was approved in the USA. RESULTS: We demonstrate that OTSC-EFTR can be very useful to manage residual neoplastic tissue that cannot be removed during conventional mucosal resection due to deeper invasion, submucosal fibrosis, scaring from prior intervention, and appendiceal involvement. Caution should be used for EFTR of the ileocecal valve lesions. CONCLUSION: We propose that layered or stacked biopsy of the appendiceal stump after EFTR should be performed to rule out a positive residual base. Due to the limited size of the FTRD resection hood (13 mm internal diameter × 23 mm depth), for larger sessile adenomas in the colon, we propose a hybrid approach for complete removal: piecemeal EMR for tumor debulking followed by OTSC-EFTR to achieve R0 resection. We believe OTSC-EFTR offers safety and efficiency with very high success rate.

Reprint of : Transcatheter closure of patent foramen ovale to prevent stroke recurrence in patients with otherwise unexplained ischaemic stroke: Expert consensus of the French Neurovascular Society and the French Society of Cardiology.

BACKGROUND: Unlike previous randomized clinical trials (RCTs), recent trials and meta-analyses have shown that transcatheter closure of patent foramen ovale (PFO) reduces stroke recurrence risk in young and middle-aged adults with an otherwise unexplained PFO-associated ischaemic stroke. AIM: To produce an expert consensus on the role of transcatheter PFO closure and antithrombotic drugs for secondary stroke prevention in patients with PFO-associated ischaemic stroke. METHODS: Five neurologists and five cardiologists with extensive experience in the relevant field were nominated by the French Neurovascular Society and the French Society of Cardiology to make recommendations based on evidence from RCTs and meta-analyses. RESULTS: The experts recommend that any decision concerning treatment of patients with PFO-associated ischaemic stroke should be taken after neurological and cardiological evaluation, bringing together the necessary neurovascular, echocardiography and interventional cardiology expertise. Transcatheter PFO closure is recommended in patients fulfilling all the following criteria: age 16-60 years; recent (≤6 months) ischaemic stroke; PFO associated with atrial septal aneurysm (>10mm) or with a right-to-left shunt>20 microbubbles or with a diameter≥2mm; PFO felt to be the most likely cause of stroke after thorough aetiological evaluation by a stroke specialist. Long-term oral anticoagulation may be considered in the event of contraindication to or patient refusal of PFO closure, in the absence of a high bleeding risk. After PFO closure, dual anti-platelet therapy with aspirin (75mg/day) and clopidogrel (75mg/day) is recommended for 3 months, followed by monotherapy with aspirin or clopidogrel for≥5 years. CONCLUSIONS: Although a big step forward that will benefit many patients has been taken with recent trials, many questions remain unanswered. Pending results from further studies, decision-making regarding management of patients with PFO-associated ischaemic stroke should be based on a close coordination between neurologists/stroke specialists and cardiologists.

A novel zipper device versus sutures for wound closure after surgery: a systematic review and meta-analysis.

We performed an updated meta-analysis to compare the efficacy of the zipper device and sutures for wound closure after surgery. A computerised literature search was performed for published trials in PubMed, Web of Science, the Cochrane Library, and Google Scholar. Two reviewers independently scrutinised the trials, extracted data, and assessed the quality of trials. The primary outcome was surgical site infections (SSI). The secondary outcomes were wound dehiscence, total wound complications, wound closure time, and scar score. Statistical analysis was performed in the Stata 12.0. Of the 130 citations, eight trials (1207 participants) met eligibility criteria and were included. The zipper device achieved a lower SSI rate (RR: 0.63, [95% CI: 0.41-0.96, P = 0.032]), a shorter wound closure time (SMD: -8.53 [95% CI: -11.93 to -5.13, P = 0.000]) and a better scar score (SMD: 0.42 [95% CI: 0.22-0.62, P = 0.000]) than sutures. No significant difference was shown in the incidence of wound dehiscence and total wound complications. Therefore, the zipper device provides the advantages of anti-infection, time-saving, and cosmesis for wound closure.

Feasibility of Underwater Clip Closure for Large Mucosal Defects after Colorectal Endoscopic Submucosal Dissection.

BACKGROUND/AIMS: Clip closure of mucosal defects after colorectal endoscopic submucosal dissection (C-ESD) may decrease the incidence of delayed adverse events. The size of the defect to be closed by conventional clip is limited, however, and we sometimes encounter incomplete closure when the defect is located at the flexure. As, theoretically, underwater clip closure (UCC) could achieve complete closure despite these difficult cases, we investigated its feasibility. METHODS: We retrospectively analyzed 21 patients who underwent UCC after C-ESD. The main outcome was the UCC success rate, defined as complete closure of the defect. Other outcomes were procedure time, number of clips, and the delayed adverse event rate. RESULTS: The median resected specimen size was 31 mm (range 18-47 mm). The UCC success rate was 100%. The median procedure time was only 11 min (range 6-21 min). The median number of clips was 9 (range 5-16). No delayed adverse event occurred. CONCLUSION: It is feasible to use UCC to close large mucosal defects, although further studies are warranted to assess its efficacy.

Endoscopic vacuum assisted wound closure (EVAC) device to treat esophageal and gastric leaks: assessing time to proficiency and cost.

BACKGROUND: Endoluminal vacuum therapy (EVAC) is an emerging procedure used to treat anastomotic leaks and/or perforations that would otherwise require surgery. The aim of this study was to determine time to proficiency in EVAC and the cost effectiveness of the procedure. METHODS: We retrospectively reviewed a prospectively maintained IRB approved database for all patients undergoing EVAC after esophageal and gastric complications between October 2013 and December 2017. Proficiency was determined by obtaining predicted estimates and analyzing the point at which average procedure time plateaued based on case volume. Total cost was calculated based on supplies and location where the procedure was performed. RESULTS: There were 50 patients (17 males, 33 female), with a mean age of 52.1 years. EVAC was placed in 23 (46%) patients with esophageal injuries and 28 (56%) with gastric injuries. Two advanced endoscopists performed all EVAC procedures in this study (1 surgeon, 1 gastroenterologist). The average procedure time for all patients was 43.5 min and the average wheel in/wheel out time for all patients was 75.6 min. Analysis of the trend based on average procedure times for EVAC revealed that proficiency was obtained after 10 cases. Total cost of the procedure is significantly lower in the GI lab compared to the operating room ($4528 vs. $11889). The majority of EVAC were performed in the GI lab (62%) compared to the operating room (38%). CONCLUSION: Successful outcomes in managing anastomotic leaks or intestinal perforations non-operatively has led to an increased interest in EVAC. For advanced endoscopists, time to proficiency is approximately 10 cases. Performing the procedure in the GI lab has a 2.5 reduction in total cost compared to the operating room.

A comparison of non-absorbable polymeric clips and staplers for laparoscopic appendiceal stump closure: analysis of 618 adult patients.

PURPOSE: The aim of this long-term study was the comparison of appendiceal stump closure with polymeric clips or staplers with respect to perioperative costs and surgical outcome under routine conditions in a university centre. METHODS: For this retrospective chart review, a total of 618 patients undergoing laparoscopic appendectomy for suspected acute appendicitis between 2010 and 2017 were reviewed: 410 patients in the stapler group and 208 patients in the clip group. The database contained demographic data, operation time, inflammation parameters, closure method of the stump, surgeon status, length of hospital stay, and complications as well as histology reports. The costs were also compared. RESULTS: Clip application was more likely among younger patients (mean age 33.6 years vs. 41.7 years). Histopathological evidence for appendiceal pathology was found in 96.6% of patients in the clip group and 99.5% of patients in the stapler group. Laparoscopic appendectomy in the clip group was more frequently performed by resident physicians (69.2%) than in the stapler group (57.8%). The mean postoperative stay was 2.9 days in the clip group and 3.7 days in the stapler group. The use of the polymeric clip resulted in considerable cost savings (19.94€ vs. 348.70€). CONCLUSIONS: The use of polymeric clips for appendiceal stump closure during appendectomy is safe and effective. The base of the appendix is amenable to clipping in 32% of appendectomies in adult patients. This study supports the use of polymeric clips over staplers to decrease cost and environmental impact.

Comparison of Transthoracic Device Closure and Surgical Repair with Right Submammary or Right Infra-axillary Thoracotomy for Perimembranous VSD.

BACKGROUND: Transthoracic device closure (TTDC) and surgical repair with right infra-axillary thoracotomy (SRRIAT) or with right submammary thoracotomy (SRSMT) are all the primary alternative treatments for restrictive perimembranous ventricular septal defect (pmVSD). However, few studies have compared them in terms of effectiveness and complications. METHODS: Patients with restrictive pmVSD undergoing TTDC, or SRRIAT, or SRSMT from March 2016 to February 2017 were retrospectively reviewed in our cardiac center. There were no differences in age (1.3 ± 1.2 vs 1.1 ± 1.1 vs 1.2 ± 1.1 years), gender (35/37 vs 30/33 vs 29/29), body weight (8.3 ± 2.6 vs 8.2 ± 2.4 vs 8.1 ± 2.5 kg), and size of VSD (4.2 ± 1.1 vs 5.2 ± 1.3 vs 5.1 ± 1.2 mm) distribution between the three groups. RESULTS: The procedure success rates were similar in the three groups. The TTDC group had the shortest operative time, postoperative mechanical ventilation time, duration of intensive care, postoperative length of hospital stay, medical cost, and length of the incision. There were no significant differences in terms of operative time, aortic cross-clamping time, duration of cardiopulmonary bypass (CPB), blood transfusion volume, mechanical ventilation time, duration of intensive care, duration of hospital stays, pleural fluid drainage, or cost between the SRSMT and SRRIAT groups. No significant differences were noted in terms of major adverse events. CONCLUSIONS: TTDC, SRRIAT, and SRSMT all showed excellent outcomes and cosmetic appearances for selected VSD patients. TTDC had advantages over SRRIAT and SRSMT in terms of short operation duration and smaller incision size and shorter durations of intensive care and hospital stays.

A new device to prevent fascial retraction in the open abdomen - proof of concept in vivo.

BACKGROUND: An open abdomen is often necessary for survival of patients after peritonitis, compartment syndrome, or in damage control surgery. However, abdominal wall retraction relieves delays and complicates abdominal wall closure. The principle of the newly fascia preserving device (FPD) is the application of anteriorly directed traction on both fascial edges over an external support through a longitudinal beam to relieve increased abdominal pressure and prevent fascial retraction. METHODS: Twelve pigs were randomly divided into two groups. Both groups underwent midline laparotomy under general anesthesia. Group one was treated with the new device, group two served as controls. The tension for closing the abdominal fascia was measured immediately after laparotomy as well as at 24 and 48 h. Vital parameters and ventilation pressure were recorded. Post mortem, all fascial tissues were histologically examined. RESULTS: All pigs demonstrated increases in abdominal circumference. In both groups, forces for closing the abdomen increased over the observation period. Concerning the central closing force after 24 h we saw a significant lower force in the FPD group (14.4 ± 3 N) vs. control group (21.6 ± 5.7 N, p < 0.001). By testing the main effects using an ANOVA analysis we found a significant group related effect concerning closing force and abdominal circumference of the FDP-group vs. control group (p < 0.001; p < 0.001). The placement of the device on chest and pelvis did not influence vital parameters and ventilation pressure. Histologic exam detected no tissue damage. CONCLUSIONS: This trial shows the feasibility to prevent fascial retraction during the open abdomen by using the new device. Thus, it is expected that an earlier closure of the abdominal wall will be possible, and a higher rate of primary closure will be attained.

Monobloc Total Thyroidectomy Using Sealing Devices: Preliminary Results and Comparative Analysis.

Background: The desire for perfect haemostasis has led the medical equipment industry to produce ideal instruments for safe thyroidectomy. Thus, haemostasis and sealing instruments such as the LigaSureTM Small Jaw, ThunderbeatTM Open Fine Jaw and HarmonicTM Focus have been indicated for thyroid surgery. Aim: The purpose of this study is to present the initial results of using these three surgical instruments for performing monobloc thyroidectomy. Material and Methods: We performed a prospective study between January 2014 and July 2019 in which we included all the patients operated by same surgeon using those 3 sealing devices. Thyroidectomies were performed using LigaSureTM Small Jaw (group 1), the ThunderbeatTM Open Fine Jaw (group 2) and HarmonicTM Focus (group 3). The groups were statistically compared in term of duration of surgery and hospitalisation, early postoperative complications as well as voice alteration or acute respiratory failure. Results: No significant differences were observed among groups in terms of patient demographics, pathological diagnoses, postoperative complications, length of hospitalization, and clinical outcomes. Operating time was shorter in group 1. Conclusions: New surgical instruments have beneficial properties, including shortening the operative time, maintaining a clean operating field, and minimising smoke released during the operation.

Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial.

BACKGROUND: Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer. METHODS: In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage. RESULTS: Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2]. CONCLUSIONS: TachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.