Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial.

BACKGROUND: Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections. METHODS: This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals. Adult patients (aged ≥18 years) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion. Exclusion criteria were impaired mental state, language problems, and participation in another intervention trial that interfered with the intervention or outcome of this trial. A central web-based randomisation tool was used to randomly assign eligible participants by permuted block randomisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures (PDS Plus) or uncoated sutures (PDS II) for abdominal fascia closure. The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation. Patients, surgeons, and the outcome assessors were masked to group assignment. Interim and final analyses were by modified intention to treat. This trial is registered with the German Clinical Trials Register, number DRKS00000390. FINDINGS: Between April 7, 2010, and Oct 19, 2012, 1224 patients were randomly assigned to intervention groups (607 to PDS Plus, and 617 to PDS II), of whom 1185 (587 PDS Plus and 598 PDS II) were analysed by intention to treat. The study groups were well balanced in terms of patient and procedure characteristics. The occurrence of surgical site infections did not differ between the PDS Plus group (87 [14·8%] of 587) and the PDS II group (96 [16·1%] of 598; OR 0·91, 95% CI 0·66-1·25; p=0·64). Serious adverse events also did not differ between the groups-146 of 583 (25·0%) patients treated with PDS Plus had at least one serious adverse event, compared with 138 of 602 (22·9%) patients treated with PDS II; p=0·39). INTERPRETATION: Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy. Innovative, multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections. FUNDING: Johnson & Johnson Medical Limited.

The Grip Concept of Incisional Hernia Repair-Dynamic Bench Test, CT Abdomen With Valsalva and 1-Year Clinical Results.

Incisional hernia is a frequent consequence of major surgery. Most repairs augment the abdominal wall with artificial meshes fixed to the tissues with sutures, tacks, or glue. Pain and recurrences plague at least 10-20% of the patients after repair of the abdominal defect. How should a repair of incisional hernias be constructed to achieve durability? Incisional hernia repair can be regarded as a compound technique. The biomechanical properties of a compound made of tissue, textile, and linking materials vary to a large extent. Tissues differ in age, exercise levels, and comorbidities. Textiles are currently optimized for tensile strength, but frequently fail to provide tackiness, dynamic stiction, and strain resistance to pulse impacts. Linking strength with and without fixation devices depends on the retention forces between surfaces to sustain stiction under dynamic load. Impacts such a coughing or sharp bending can easily overburden clinically applied composite structures and can lead to a breakdown of incisional hernia repair. Our group developed a bench test with tissues, fixation, and textiles using dynamic intermittent strain (DIS), which resembles coughing. Tissue elasticity, the size of the hernia under pressure, and the area of instability of the abdominal wall of the individual patient was assessed with low-dose computed tomography of the abdomen preoperatively. A surgical concept was developed based on biomechanical considerations. Observations in a clinical registry based on consecutive patients from four hospitals demonstrate low failure rates and low pain levels after 1 year. Here, results from the bench test, the application of CT abdomen with Valsalva's maneuver, considerations of the surgical concept, and the clinical application of our approach are outlined.

Primary and Recurrent Repair of Incisional Hernia Based on Biomechanical Considerations to Avoid Mesh-Related Complications.

Aim: Mechanical principles successfully guide the construction of polymer material composites in engineering. Since the abdominal wall is a polymer composite augmented with a textile during incisional hernia repair we ask: can incisional hernia be repaired safely and durably based on biomechanical principles? Material and Methods: Repair materials were assessed on a self-built bench test using pulse loads to elude influences on the reconstruction of the abdominal wall. Tissue elasticity was analyzed preoperatively as needed with computed tomography at rest and during Valsalva's maneuver. Preoperatively, the critical retention force of the reconstruction to pulse loads was calculated and a biomechanically durable repair was designed based on the needs of the individual patient. Intraoperatively, the design was adjusted as needed. Hernia meshes with high grip factors (Progrip®, Dahlhausen® Cicat) were used for the repairs. Mesh sizes, fixation elements and reconstructive details were oriented on the biomechanical design. All patients recieved single-shot antibiosis. Patients were discharged after full ambulation was achieved. Results: A total of 163 patients (82 males and 81 females) were treated for incisional hernia in four hospitals by ten surgeons. Primary hernia was repaired in 119 patients. Recurrent hernia was operated on in 44 cases. Recurrent hernia was significantly larger (median 161 cm2 vs. 78 cm2; u-test: p = 0.00714). Re-do surgery took significantly longer (median 229 min vs. 150 min; p < 0.00001) since recurrent disease required more often transversus abdominis release (70% vs. 47%). GRIP tended to be higher in recurrent repair (p = 0.01828). Complication rates (15%) and hospital stay were the same (6 vs. 6 days; p = 0.28462). After 1 year, no recurrence was detected in either group. Pain levels were equally low in both primary and recurrent hernia repairs (median NAS = 0 in both groups at rest and under load, p = 0.88866). Conclusion: Incisional hernia can safely and durably be repaired based on biomechanical principles both in primary and recurrent disease. The GRIP concept provides a base for the application of biomechanical principles in incisional hernia repair.

Biomechanical Influences on Mesh-Related Complications in Incisional Hernia Repair.

Aim: Hernia repair strengthens the abdominal wall with a textile mesh. Recurrence and pain indicate weak bonds between mesh and tissue. It remains a question which biomechanical factors strengthen the mesh-tissue interface, and whether surgeons can enhance the bond between mesh and tissue. Material and Methods: This study assessed the strength of the mesh-tissue interface by dynamic loads. A self-built bench test delivered dynamic impacts. The test simulated coughing. Porcine and bovine tissue were used for the bench test. Tissue quality, mesh adhesiveness, and fixation intensity influenced the retention power. The influences were condensed in a formula to assess the durability of the repair. The formula was applied to clinical work. The relative strength of reconstruction was related to the individual human abdominal wall. From computerized tomography at rest and during Valsalva's Maneuver, the tissue quality of the individual patient was determined before surgery. Results: The results showed that biomechanical parameters observed in porcine, bovine, and human tissue were in the same range. Tissues failed in distinct patterns. Sutures slackened or burst at vulnerable points. Both the load duration and the peak load increased destruction. Stress concentrations elevated failure rates. Regional areas of force contortions increased stress concentrations. Hernia repair improved strain levels. Measures for improvement included the closure of the defect, use of higher dynamic intermittent strain (DIS) class meshes, increased mesh overlap, and additional fixation. Surgeons chose the safety margin of the reconstruction as desired. Conclusion: The tissue quality has now been introduced into the concept of a critical and a gained resistance toward pressure-related impacts. A durable hernia repair could be designed from available coefficients. Using biomechanical principles, surgeons could minimize pain levels. Mesh-related complications such as hernia recurrence can potentially be avoided in incisional hernia repair.

Prophylactic onlay reinforcement with absorbable mesh (polyglactin) is associated with less early wound complications after kidney transplantation: A preliminary study.

Incidence of wound complications after kidney transplantation (KTx) is still considerable. Here, we report the impact of prophylactic absorbable polyglactin (Vicryl®) mesh reinforcement on the incidence of short-term post-KTx wound complications. Sixty-nine patients were analyzed; 23 with and 46 without preventive onlay mesh reinforcement. Surgical site infections (SSI) were seen in six (26%) patients in the mesh group and in 17 (37%) patients in no-mesh group. A lower, but not statistically significant, rate of early postoperative wound complications occurred in the mesh group. Wound complications were observed in seven (30%) patients in the mesh group and in 23 (50%) patients in the no-mesh group. There was no association between mesh placement and SSI incidence (odds ratios [OR] 0.60, 95% confidence interval [CI] 0.20-1.82, p = 0.369) and wound complications (OR 0.44, 95% CI 0.15-1.26, p = 0.126). Therefore, we conclude that mesh reinforcement does not increase the risk of SSI and overall wound complications. Long-term outcomes have to be evaluated in a randomized trial setting. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:67-72, 2020.

Assessing the GRIP of Ventral Hernia Repair: How to Securely Fasten DIS Classified Meshes.

Recurrences are frequently observed after ventral hernia repair. Based on clinical data, the mesh-defect area ratio (MDAR) can lead to lower recurrence rates. Using dynamic intermittent strain (DIS) in a pig tissue model, MDAR can be modified to give a measure called grip to better assess the mechanical stability of ventral hernia repair. The focus of this experimental study is to assess the different aspects of mesh overlap (OL) and fixation only in bridging repair of ventral hernias. DIS mimics coughing actions in an ex vivo model with the repetition of submaximal impacts delivered via a hydraulically driven plastic containment. Tissue derived from pig bellies simulates a ventral hernia with varying defect sizes. MDAR is calculated from the hernia orifice and the mesh OL. Commercially available meshes were strengthened with glue, tacks, and sutures to bridge the defects. The reconstructions are strained with up to 425 dynamic impacts. The grip of each repair is assessed using MDAR modified by the strength of the fixation. The DIS classification is based on bridging of a 5 cm ventral hernia orifice with an OL of 5 cm in a sublay position. The classification discriminates meshes properties upon DIS strain. MDAR is calculated to be 9 under these conditions. Decreasing the OL or increasing the hernia orifice reduces MDAR to numbers below 9. MDAR is modified to reach GRIP. Closure of the peritoneum adds about 4 to the grip given by MDAR. The multiplying factor of a transmural suture or one tack of Securestrap® or Protack® is 0.5 times the number of tacks applied. The multiplier given by a bonding spot of Glubran® is similar to that of an Absorbatack® being 0.33. Plotting the likelihood of a bridging repair to survive more than 400 DIS impacts versus the grip estimated from the factors given above, the grip to be passed for a durable repair is 10 for Parietex Progrip®, and Dynamesh Cicat® and 25 for Dynamesh IPOM®. Clinical data previously published can be reculculated to assess MDAR and permit an estimation of the grip of the reconstruction. In these recalculations, a correlation between MDAR and long-term recurrence rates is found. A dimensionless number called grip can be calculated. The grip can be modified by fixation in a reproducible way. A higher grip can improve the durability of ventral hernia repair. We believe that a higher grip leads to lower recurrence rates in the clinical setting.

Functional Results after Repair of Large Hiatal Hernia by Use of a Biologic Mesh.

BACKGROUND: The aim of this observational study is to analyze the results of patients with large hiatal hernia and upside-down stomach after surgical closure with a biological mesh (Permacol(®), Covidien, Neustadt an der Donau, Germany). Biological mesh is used to prevent long-term detrimental effects of artificial meshes and to reduce recurrence rates. METHODS: A total of 13 patients with a large hiatal hernia and endothoracic stomach, who underwent surgery between 2010 and 2014, were included. Interviews and upper endoscopy were conducted to determine recurrences, lifestyle restrictions, and current complaints. RESULTS: After a mean follow-up of 26 ± 18 months (range: 3-58 months), 10 patients (3 men, mean age 73 ± 13, range: 26-81 years) were evaluated. A small recurrent axial hernia was found in one patient postoperatively. Dysphagia was the most common complaint (four cases); while in one case, the problem was solved after endoscopic dilatation. In three cases, bloat and postprandial pain were documented. In one case, an explantation of the mesh was necessary due to mesh migration and painful adhesions. In one further case with gastroparesis, pyloroplasty was performed without success. The data are compared to the available literature. It was found that dysphagia and recurrence rates are unrelated both in biological and in synthetic meshes if the esophagus is encircled. In series preserving the esophagus at least partially uncoated, recurrences after the use of biological meshes relieve dysphagia. After the application of synthetic meshes, dysphagia is aggravated by recurrences. CONCLUSION: Recurrence is rare after encircling hiatal hernia repair with the biological mesh Permacol(®). Dysphagia, gas bloat, and intra-abdominal pain are frequent complaints. Despite the small number of patients, it can be concluded that a biological mesh may be an alternative to synthetic meshes to reduce recurrences at least for up to 2 years. Our study demonstrates that local fibrosis and thickening of the mesh can affect the outcome being associated with abdominal discomfort despite a successful repair. The review of the literature indicates comparable results after 2 years with both biologic and synthetic meshes embracing the esophagus. At the same point in time, reconstruction with synthetic and biologic materials differs when the esophagus is not or only partially encircled in the repair. This is important since encircling artificial meshes can erode the esophagus after 5-10 years.

Evidence for Replacement of an Infected Synthetic by a Biological Mesh in Abdominal Wall Hernia Repair.

INTRODUCTION: The incidence of deep infection using a synthetic mesh in inguinal hernia repair is low and reported to be well below 1%. This is in contrast to incisional hernia surgery where the reported incidence is 3% respective 13% comparing laparoscopic to open mesh repair reported in a Cochrane review. Main risk factors were long operation time, surgical site contamination, and early wound complications. An infected mesh can be preserved using conservative treatment were negative pressure wound therapy (VAC(®)) could play an important role. If strategy fails, the mesh needs to be removed. This review aims to look at evidence for situations were a biological mesh would work as a replacement of a removed infected synthetic mesh. MATERIALS AND METHODS: A literature search of the Medline database was performed using the PubMed search engine. Twenty publications were found relevant for this review. RESULTS: For studies reviewed three options are presented: removal of the infected synthetic mesh alone, replacement with either a new synthetic or a new biological mesh. Operations were all performed at specialist centers. Removal of the mesh alone was an option limited to inguinal hernias. In ventral/incisional hernias, the use of a biological mesh for replacement resulted in a very high recurrence rate, if bridging was required. Either a synthetic or a biological mesh seems to work as a replacement when fascial closure can be achieved. Evidence is though very low. CONCLUSION: When required, either a synthetic or a biological mesh seems to work as a replacement for an infected synthetic mesh if the defect can be closed. It is, however, not recommended to use a biological mesh for bridging. Mesh replacement surgery is demanding and is recommended to be performed in a specialist center.

Dynamic intermittent strain can rapidly impair ventral hernia repair.

Ventral hernia repair fails frequently despite advanced mesh inserting surgery. A model for dynamic intermittent straining (DIS) of ventral hernia repairs was developed. The influence of phospholipids, position, overlap, fixation and tissue quality of various meshes on the durability of hernia repair was studied. DIS comprises the repetition of submaximal impacts delivered via a hydraulically driven plastic containment. Pig tissues simulate a ventral hernia with a standardized 5cm defect. Commercially available meshes strengthened with tacks, glue and sutures were used to bridge this defect in an underlay (IPOM) or sublay (retromuscular) position starting with a 5cm overlap in all directions. We tested 35 different ways of ventral hernia repair with up to 425 submaximal intermittent dynamic impacts until mesh dislocation occurred 10 times or a maximum of 4000 impacts each were withstood. The likelihood of a failing repair was related to the mesh, the lubricants, the position, the overlap, the fixation and the tissue quality. Most meshes dislocated easily and required fixation. One of the meshes tested was stable without fixation with a 5cm overlap and failed after reducing the overlap. Phospholipids exerted a strong influence on the biomaterial tested. The sublay position was about 10% more durable in comparison to the IPOM position. DIS revealed distinct degrees of stability with primarily stable, intermediate and primarily unstable repairs. Based on the DIS results available, the currently used ventral hernia repair options can be classified. In the future, DIS investigations can improve the durability of hernia repair.

Correlation of hemodynamic impact and morphologic degree of renal artery stenosis in a canine model.

In a noninvasive comprehensive magnetic resonance (MR) examination, the morphologic degree of renal artery stenosis was correlated to corresponding changes in renal artery flow dynamics. Different degrees of stenosis were created with the use of a chronically implanted inflatable arterial cuff in seven dogs. For each degree of stenosis, an ultrafast three-dimensional gadolinium MR angiography with high spatial resolution was performed, followed by cardiac-gated MR flow measurements with high temporal resolution for determination of pulsatile flow profiles and mean flow. Flow was also measured by a chronically implanted flow probe. In three of the dogs, trans-stenotic pressure gradients (DeltaP) also were measured via implanted catheters. Five different degrees of stenosis could be differentiated in the MR angiograms (0%, 30%, 50%, 80%, >90%). The MR flow data agreed with the flow probe within +/-20%. Stenoses between 30 and 80% gradually reduced the early systolic peak (Max(1)) of the flow profile but only minimally affected the midsystolic peak (Max(2)) or mean flow. Stenoses of more than 90% significantly depressed mean flow by more than 50%. The ratio between Max(1) and Max(2) (Rmax(1/2)) gradually fell with the degree of stenosis. The onset of significant mean flow reduction and DeltaP was indicated by a drop of Rmax(1/2) below 1 to 1.2. Thus, the analysis of high-resolution flow profiles allows detection of early hemodynamic changes even at degrees of stenoses not associated with a reduction of mean flow. Rmax(1/2) allows differentiation of the grade of hemodynamic compromise for a given morphologic stenosis independent of mean flow in a single comprehensive MR examination.

Prognostic impact of reoxygenation in advanced cancer of the head and neck during the initial course of chemoradiation or radiotherapy alone.

BACKGROUND: Previous studies have shown that radiation of hypoxic tumors can result in reoxygenation phenomenon. The relevance of this phenomenon for prognosis is unclear. This study analyzes whether the presence of hypoxia, or the extent to which reoxygenation occurs during the initial phase of primary chemoradiation or radiotherapy, can predict the clinical outcome in advanced tumors of the head and neck. METHODS: The distribution of oxygen partial pressures was determined using pO(2) histography (Kimoc 6650, Sigma pO(2)-Histograph, Eppendorf, Hamburg, Germany). In cervical lymph node metastases of 37 patients with advanced carcinoma of the head and neck (stage IV, UICC), these values were determined before the start of primary chemoradiation or radiotherapy alone (pO(2)x). Thirty-two of 37 patients were reexamined after 1 week of therapy, and measurements were taken again in the same nodes (pO(2)y). The results obtained from these measurements were correlated with both, the initial response to therapy and follow-up results (43 months). RESULTS.: In all patients, pronounced hypoxia (median pO(2), 3.2 mmHg) was found before therapy. In 19 of 32 patients, chemoradiation/radiotherapy induced reoxygenation (deltaO(2) = pO(2)y - pO(2)x), with median deltapO(2) increasing to 6.5 mmHg after 1 week (p =.049). The group of patients with a complete or partial response showed only a slight increase of median deltapO(2) (1 mmHg) compared with a strong reoxygenation effect in the group of patients with no change (mean value of median deltapO(2) = 10.3 mmHg; p =.0062). The group of patients with deltapO(2) values lower than median showed significantly better survival rates compared with the other group (p =.036). CONCLUSION: These data suggest that reoxygenation under therapy may have prognostic relevance in patients with advanced carcinoma of the head and neck treated by primary chemoradiation or radiation therapy. Remarkably, however, a poor outcome was associated with a higher degree of reoxygenation.

Morphologic and functional magnetic resonance imaging of renal artery stenosis: a multireader tricenter study.

The effect of combined morphologic and functional magnetic resonance (MR) imaging on the interobserver and intermodality variability for the grading of renal artery stenosis is assessed. In a randomized, blinded tricenter analysis, seven readers evaluated 43 renal arteries on x-ray digital subtraction angiography (DSA), 3D-Gadolinium MR angiography (3D-Gd-MRA), cine phase-contrast flow measurement (PC-flow), and a combined analysis of the last two. Interobserver variability was assessed for the grading of renal artery stenosis as well as regional vessel visibility. Intermodality variability for stenosis grading was analyzed in cases in which the readers agreed on the degree of stenosis in DSA. DSA had a substantial interobserver variability for the grading of stenosis (mean kappa kappa 0.64). 3D-Gd-MRA revealed a slightly improved interobserver variability but incorrectly graded 6 of 34 stenoses on a two-point scale (<50%, > or =50%). The combined approach of 3D-Gd-MRA and PC-flow revealed the best (P = 0.0003) interobserver variability (median kappa = 0.75) and almost perfect intermodality agreement with DSA (97% of cases). These findings were confirmed in a prospective analysis of 97 renal arteries. The vessel visibility of the renal artery ostium was significantly better in 3D-Gd-MRA than in DSA, whereas the visibility of the hilar and intrarenal vessels was significantly worse (P = 0.0001). A combined morphologic and functional MR examination significantly reduces interobserver variability and offers reliable and reproducible grading of renal artery stenosis based on stenosis morphology and hemodynamic changes. It can be considered a safe and noninvasive alternative for diagnostic DSA in cases that do not require assessment of intrarenal vessels.