Economic Analysis of AbClo, a Novel Abdominal Fascia Closure Device, for Patients With an Open Abdomen Following Trauma or Acute Abdominal Surgery.

BACKGROUND: Open Abdomen (OA) cases represent a significant surgical and resource challenge. AbClo is a novel non-invasive abdominal fascial closure device that engages lateral components of the abdominal wall muscles to support gradual approximation of the fascia and reduce the fascial gap. The study objective was to assess the economic implications of AbClo compared to negative pressure wound therapy (NPWT) alone on OA management. METHODS: We conducted a cost-minimization analysis using a decision tree comparing the use of the AbClo device to NPWT alone among patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure. The time horizon was limited to the length of the inpatient hospital stay, and costs were considered from the perspective of the US Medicare payer. Clinical effectiveness data for AbClo was obtained from a randomized clinical trial. Cost data was obtained from the published literature. Probabilistic and deterministic sensitivity analyses were performed. The primary outcome was incremental cost. RESULTS: The mean cumulative costs per patient were $76 582 for those treated with NPWT alone and $70,582 for those in the group treated with the AbClo device. Compared to NPWT alone, AbClo was associated with lower incremental costs of -$6012 (95% CI -$19 449 to +$1996). The probability that AbClo was cost-savings compared to NPWT alone was 94%. CONCLUSIONS: The use of AbClo is an economically attractive strategy for management of OA in in patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure.

Incisional Surgical Site Infections After Mass and Layered Closure of Upper Abdominal Transverse Incisions: First Results of a Randomized Controlled Trial.

OBJECTIVE: To compare the early results of mass and layered closure of upper abdominal transverse incisions. SUMMARY OF BACKGROUND DATA: Contrary to midline incisions, data on closure of transverse abdominal incisions are lacking. METHODS: This is the first analysis of a randomized controlled trial primarily designed to compare mass with layered closure of transverse incisions with respect to incisional hernias. Patients undergoing laparotomy through upper abdominal transverse incisions were randomized to either mass or layered closure with continuous sutures. Incisional surgical site infection (incisional-SSI) was the primary end-point. Secondary end-points comprised suture-to-wound length ratio (SWLR), closure duration, and fascial dehiscence (clinicatrials.gov NCT03561727). RESULTS: A total of 268 patients were randomized to either mass (n=134) or layered (n=134) closure. Incisional-SSIs occurred in 24 (17.9%) and 8 (6.0%) patients after mass and layered closure, respectively (P =0.004), with crude odds ratio (OR) of 0.29 [95% confidence interval (95% CI) 0.13-0.67; P =0.004]. Layered technique was independently associated with fewer incisional-SSIs (OR: 0.29; 95% CI 0.12-0.69; P =0.005). The number needed to treat, absolute, and relative risk reduction for layered technique in reducing incisional-SSIs were 8.4 patients, 11.9%, and 66.5%, respectively. Dehiscence occurred in one (0.8%) patient after layered closure and in two (1.5%) patients after mass closure (P >0.999). Median SWLR were 8.1 and 5.6 (P <0.001) with median closure times of 27.5 and 25.0 minutes (P =0.044) for layered and mass closures, respectively. CONCLUSIONS: Layered closure of upper abdominal transverse incisions should be preferred due to lower risk of incisional-SSIs and higher SWLR, despite clinically irrelevant longer duration.

Prophylactic sublay non-absorbable mesh positioning following midline laparotomy in a clean-contaminated field: randomized clinical trial (PROMETHEUS).

BACKGROUND: Incisional hernia is a frequent postoperative complication after midline laparotomy. Prophylactic mesh augmentation in abdominal wall closure after elective surgery is recommended, but its role in emergency surgery is less well defined. METHODS: This prospective randomized trial evaluated the incidence of incisional hernia in patients undergoing urgent midline laparotomy for clean-contaminated surgery. Closure using a slowly absorbable running suture was compared with closure using an additional sublay mesh (Parietex ProGrip™). Patients were randomized just before abdominal wall closure using computer-generated permuted blocks. Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to the group allocation. Patients were followed up for 24 months by means of clinical and ultrasonographic evaluations. RESULTS: From January 2015 to June 2018, 200 patients were randomized: 100 to primary closure (control group) and 100 to Parietex ProGrip™ mesh-supported closure (mesh group). Eight patients in the control group and six in the mesh group were lost to follow-up. By 24 months after surgery, 21 patients in the control group and six in the mesh group had developed incisional hernia (P = 0.002). There was no difference between groups in the incidence of haematoma (2 versus 5; P = 0.248) and superficial wound infection (4 versus 5; P = 0.733). Multivariable analysis confirmed the role of mesh in preventing incisional hernia (odds ratio 0.11, 95 per cent c.i. 0.03 to 0.37; P < 0.001). One patient in the mesh group required mesh removal because of deep infection. CONCLUSION: Prophylactic mesh-augmented abdominal wall closure after urgent laparotomy in clean-contaminated wounds is safe and effective in reducing the incidence of incisional hernia. Registration number: NCT04436887 (http://www.clinicaltrials.gov).

Infectious Complication in Relation to the Prophylactic Mesh Position: The PRIMA Trial Revisited.

BACKGROUND: Prophylactic mesh reinforcement has proven to reduce the incidence of incisional hernia (IH). Fear of infectious complications may withhold the widespread implementation of prophylactic mesh reinforcement, particularly in the onlay position. STUDY DESIGN: Patients scheduled for elective midline surgery were randomly assigned to a suture closure group, onlay mesh group, or sublay mesh group. The incidence, treatment, and outcomes of patients with infectious complications were assessed through examining the adverse event forms. Data were collected prospectively for 2 years after the index procedure. RESULTS: Overall, infectious complications occurred in 14/107 (13.3%) patients in the suture group and in 52/373 (13.9%) patients with prophylactic mesh reinforcement (p = 0.821). Infectious complications occurred in 17.6% of the onlay group and 10.3% of the sublay group (p = 0.042). Excluding anastomotic leakage as a cause, these incidences were 16% (onlay) and 9.7% (sublay), p = 0.073. The mesh could remain in-situ in 40/52 (77%) patients with an infectious complication. The 2-year IH incidence after onlay mesh reinforcement was 10 in 33 (30.3%) with infectious complications and 15 in 140 (9.7%) without infectious complications (p = 0.003). This difference was not statistically significant for the sublay group. CONCLUSIONS: Prophylactic mesh placement was not associated with increased incidence, severity, or need for invasive treatment of infectious complications compared with suture closure. Patients with onlay mesh reinforcement and an infectious complication had a significantly higher risk of developing an incisional hernia, compared with those in the sublay group.

Early versus delayed complex abdominal wall reconstruction with biologic mesh following damage-control surgery.

BACKGROUND: Damage-control surgery for trauma and intra-abdominal catastrophe is associated with a high rate of morbidities and postoperative complications. This study aimed to compare the outcomes of patients undergoing early complex abdominal wall reconstruction (e-CAWR) in acute settings versus those undergoing delayed complex abdominal wall reconstruction (d-CAWR). METHOD: This study was a pooled analysis derived from the retrospective and prospective database between the years 2013 and 2019. The outcomes were compared for differences in demographics, presentation, intraoperative variables, Ventral Hernia Working Grade (VHWG), US Centers for Disease Control and Prevention wound class, American Society of Anesthesiologists (ASA) scores, postoperative complications, hospital length of stay, and readmission rates. We performed Student's t test, χ2 test, and Fisher's exact test to compare variables of interest. Multivariable linear regression model was built to evaluate the association of hospital length of stay and all other variables including the timing of complex abdominal wall reconstruction (CAWR). A p value of <0.05 was considered significant. RESULTS: Of the 236 patients who underwent CAWR with biological mesh, 79 (33.5%) had e-CAWR. There were 45 males (57%) and 34 females (43%) in the e-CAWR group. The ASA scores of IV and V, and VHWG grades III and IV were significantly more frequent in the e-CAWR group compared with the d-CAWR one. Postoperatively, the incidence of surgical site occurrence, Clavien-Dindo complications, comprehensive complication index, unplanned reoperations, and mortality were similar between the two groups. Backward linear regression model showed that the timing of CAWR (ß = -11.29, p < 0.0001), ASA (ß = 3.98, p = 0.006), VHWG classification (ß = 3.62, p = 0.015), drug abuse (ß = 13.47, p = 0.009), and two comorbidities of cirrhosis (ß = 12.34, p = 0.001) and malignancy (ß = 7.91, p = 0.008) were the significant predictors of the hospital length of stay left in the model. CONCLUSION: Early CAWR led to shorter hospital length of stay compared with d-CAWR in multivariable regression model. LEVEL OF EVIDENCE: Therapeutic, level IV.

Barbed vs conventional suture at cesarean delivery: A systematic review and meta-analysis.

INTRODUCTION: Barbed sutures are used in cesarean delivery with the intended benefits of better tissue approximation, hemostasis, and strength, as well as reduced operative time. A systematic review and meta-analysis was undertaken to assess the safety and efficacy of the use of barbed suture compared with conventional sutures in cesarean delivery. MATERIAL AND METHODS: MEDLINE, EMBASE, PubMed, Scopus, Cochrane CENTRAL, and three clinical trial registries, were searched from inception to December 2019, without restriction by language or publication year. Randomized controlled trials comparing the use of barbed suture with conventional sutures in closure of any layer (uterine/fascial/skin) during cesarean delivery were included. The safety outcomes included estimated blood loss, pain, mortality, and other morbidity including infection, re-operation or re-admission. Effectiveness outcomes included closure time, need for additional suture and scar integrity. Study selection, data extraction, risk-of-bias, and quality assessment were independently performed by two authors. Primary analysis compared outcomes for all layers of surgical closure, whereas subgroup analysis was performed by individual layer. Pooled mean differences (MD) and risk ratios (RR) with 95% CI were calculated using a random effects model. Level of evidence was assessed using GRADE criteria. PROSPERO registration number: CRD42020168859. RESULTS: The review included four trials (three comparing uterine closure and one comparing skin closure), at high risk of bias, representing 460 participants. Primary analysis showed no morbidity differences between two groups. The use of barbed suture for uterine closure was associated with shorter incision closure time (MD 110.58 seconds, 95% CI 93.79-127.36 seconds), shorter total surgical time (MD 1.92 minutes, 95% CI 0.03-3.80 minutes), and a reduced need for additional hemostatic sutures (RR 0.39, 95% CI 0.28-0.54), with no difference in estimated blood loss (MD 46.17 mL, 95% CI 13.55 to -105.89 mL) or postoperative morbidity (RR 0.96, 95% CI 0.46-2.01). The level of evidence was deemed to be low to very low, based on inconsistency and imprecision of results. CONCLUSIONS: Barbed sutures may be a suitable alternative to conventional sutures for uterine closure because they reduce uterine repair time, total surgical time, and the need for additional hemostatic sutures, without an increase in blood loss or maternal morbidity.

A safe and reliable technique for fascial closure without special devices after laparoscopic surgery.

INTRODUCTION: To prevent port-site hernia, we established a simple and low-cost closure method that uses a venous catheter needle and suture, without any other special devices. MATERIALS AND SURGICAL TECHNIQUE: We used the inner needle of a 16-G venous catheter and a 2-0 absorbable bladed suture. To evaluate the efficacy of this technique, the procedure time was noted and compared among three operators (an experienced surgeon and two inexperienced surgeons). DISCUSSION: The median suturing time was 60.5 seconds (range, 26-130 seconds) per incision. Even an unexperienced surgeon can close the fascia safely and quickly after some experience with the procedure.

Dual Tack Mesh Fixation System on a Cadaveric Porcine Model-Creation of a Mesh Fixation System for Hernia Treatment and Prevention.

BACKGROUND: Onlay mesh repair (OMR) has proven to be a widely used, simple, and effective technique for treatment and prevention of hernia occurrence. Despite established benefits, there is still a lack of widespread adoption. In this study, we present the Dual Tacker Device (DTD), an enabling technology that directly addresses the limitations to the adoption of OMR, saving surgical time and effort and making OMR more reproducible across a wide range of patients. METHODS: The DTD mesh fixation system is a semiautomated, hand-held, disposable, multipoint onlay mechanical mesh fixation system that is able to rapidly and uniformly tension and fixate mesh for both hernia treatment and prevention. A cadaveric porcine model was used as a pilot test conducted during a 2 day session to assess the usability of the device and to show that the DTD provided equivalent or superior biomechanical support compared with the standard of care (hand-sewn, OptiFix). RESULTS: Our study included 37 cadaveric porcine incisional closure abdominal wall models. These were divided into four groups: DTD-mediated OMR (n = 14), hand-sewn OMR (n = 7), OptiFix OMR (n = 9), and suture-only repair (no mesh) (n = 7). Eight surgical residents performed device-mediated and hand-sewn OMR. Average time to completion was fastest in the DTD cohort (45.6s) with a statistically significant difference compared with the hand-sewn cohort (343.1s, P < 0.01). No difference in tensile strength was noted between DTD (195.32N), hand-sewn (200.48N), and OptiFix (163.23N). Discreet hand movements were smallest in the DTD (29N) and significant (P < 0.01) when compared with hand-sewn (202N) and OptiFix (35N). CONCLUSIONS: The use of the DTD is not only feasible, but demonstrated improvement in time to completion and economy of movement over current standard of care. While more testing is needed and planned, compared with conventional approaches, the DTD represents a robust proof of principle with promising implications for clinical feasibility and adoptability.

Closing Contaminated Fascial Defects With Synthetic Mesh and a Vacuum-Assisted Closure Device.

BACKGROUND: The use of synthetic mesh is considered too high risk, and therefore, not an option when closing a contaminated abdominal fascial defect. This study evaluated the clinical outcomes when using synthetic mesh combined with vacuum-assisted closure (VAC) dressing to close these facial defects. MATERIALS AND METHODS: From 2010 to 2016, a retrospective review was performed, including 34 patients in a single rural trauma center who underwent a damage control laparotomy in the presence of a contaminated or infected field. Definitive abdominal closure with a bridging polypropylene mesh along with the application of a VAC dressing was done in all cases. Data collection included baseline demographics, operative indication, postoperative complications, mortality and length of follow up. RESULTS: Median age of the patients was 67 y (IQR 40-87 y), with 22 (65%) being male at the time of operation. The median duration of clinical follow-up was 15.15 mo. The observed complications included three fistulas, two hernias, nine draining sinus tracts, and three mesh explanations with an overall complication rate of 41.1%. Although the absolute observed fistula rate was 8.8% (3 cases), the adjusted mesh-related fistulas formation rate after chart review was 0.0%. No mortalities were attributed directly to mesh-related complication. CONCLUSIONS: This study found no mesh-related fistulas when using a synthetic mesh along with a VAC dressing for abdominal closure in a contaminated field. These results may provide a platform for further study regarding the safety of this technique.

Biomechanical Parameters of Mesh Reinforcement and Analysis of a Novel Device for Incisional Hernia Prevention.

BACKGROUND: Prophylactic mesh augmentation (PMA) is an effective technique utilized to reduce the risk of incisional hernia. This study analyzes the biomechanical characteristics of a mesh-reinforced closure and evaluates a novel prophylactic mesh implantation device (SafeClose Roller System; SRS). MATERIALS AND METHODS: A total of eight senior-level general surgery trainees (≥4 years of training) from the University of Pennsylvania Health System participated in the study. Biomechanical strength, mesh stiffness, mesh uniformity, and time efficiency for fixation were compared among hand-sewn mesh fixation, SRS mesh fixation and a no-mesh fixation control. Porcine abdominal wall specimens served as simulated laparotomy models. RESULTS: Biomechanical load strength was significantly higher for mesh reinforced repairs (P = 0.009). The SRS resulted in a stronger biomechanical force than hand-sewn mesh (21.2 N stronger, P = 0.317), with more uniform mesh placement (P < 0.01), faster time of fixation (P < 0.001) and with less discrete hand-movements (P < 0.001). CONCLUSIONS: Mesh reinforcement for incisional reinforcement has a significant impact on the strength of the closure. The utilization of a mesh-application system has the potential to amplify the advantages of mesh reinforcement by providing efficiency and consistency to fixation methods, with similar biomechanical strength to hand-sewn mesh. Additional in vivo analysis and randomized controlled trials are needed to further assess clinical efficacy.

Wittmann Patch : Superior Closure for the Open Abdomen.

INTRODUCTION: Damage control laparotomy (DCL) is a life-saving surgical technique, but the resultant open abdomen (OA) carries serious morbidity/mortality. Many methods are utilized to manage OAs, but discrepancy exists in distinguishing closure from coverage techniques. We observed a difference in our DCL patient outcomes managed with the Wittmann Patch (WP) closure device versus the more popular ABThera (AB) coverage device. We hypothesized that the WP contributed to an improved fascial closure rate of the OAs after DCL. METHODS: A retrospective review of OAs managed with the AB or WP at our Level 1 trauma center was performed using billing codes to capture DCL patients from 2011 to 2019. Patients were divided into AB alone or WP groups. Major endpoints included primary fascial closure (PFC) and delayed fascial closure (DFC, fascial closure after greater than 7 days). RESULTS: 189 patients were identified as AB and 38 as WP. Rates of death before closure, age, gender, and Injury Severity Score were similar in both groups. PFC = 81%-90% for AB versus WP, respectively. Excluding patients with preexisting hernias PFC = 87%-100% for AB versus WP (P < .05) and DFC = 44%-100% for AB versus WP (P ≤ 0.001). WP had a statistically higher rate of PFC and DFC. There was a decreased incidence of complications in the WP versus AB group. CONCLUSIONS: While not well reported in the peer-reviewed literature, the application of the WP for management of the OA is an active form of pursuing PFC when compared with the AB, a coverage device. Our interinstitutional results have demonstrated superior PFC and DFC rates and fewer complications, in patients managed with the WP compared with the AB.

Biologic mesh implantation is associated with serious abdominal wall complications in patients undergoing emergency abdominal surgery: A randomized-controlled clinical trial.

BACKGROUND: Open, emergency abdominal surgery is associated with a high incidence of fascial dehiscence and incisional hernia. Implantation of biologic meshes potentially reinforces the abdominal wall and therefore decreases such complications. The aim of this prospective randomized study was to compare the outcome after prophylactic intraperitoneal implantation of a biologic Strattice mesh (Allergan, Dublin, Ireland) with standard abdominal closure in patients undergoing emergency abdominal surgery. METHODS: A two-arm randomized clinical trial was performed in patients undergoing emergency abdominal surgery at Bern University Hospital, University of Bern, Switzerland, from April 2016 to March 2019. Patients were randomly assigned to prophylactic implantation of a biological intraperitoneal mesh using Strattice, Allergan (mesh group), or standard abdominal closure using a single, continuous running suture (no-mesh group). Because of safety concerns, patient enrollment was closed prematurely. RESULTS: Eligibility for inclusion was assessed in 61 patients. A total of 48 patients were randomized (21 in the mesh group, 28 in the no-mesh group). No differences in baseline characteristics were found. Abdominal wall complications requiring reoperations were more frequent in the mesh group compared to the no-mesh group (5 [83.3%] of 13 vs. 1 [14.3%] of 13 patients, p = 0.026). Mesh-associated abdominal wall complications included nonintegration of the mesh into the abdominal wall, dissolution of the mesh, and mesh-related infections. CONCLUSION: In patients undergoing emergency abdominal surgery, intraperitoneal biologic Strattice mesh implantation is associated with significantly more frequent abdominal wall complications requiring reoperation. Therefore, the use of such meshes cannot be recommended in the contaminated environment of emergency abdominal surgery. LEVEL OF EVIDENCE: Therapeutic, level I.

Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial.

BACKGROUND: Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed. The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge. A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications. This study has a number of limitations. There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications. METHODS: This is a 1:1 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year. The study will be conducted at AUBMC over a 3-year period. Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique. In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0.05, we will need to recruit 114 patients per arm. After adjusting for loss to follow-up, target recruitment is 274 subjects. We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate. Univariate and multivariate logistic regression will be done. DISCUSSION: This trial will assess postop complications following abdominal midline wound closures via two different suturing techniques. This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure. TRIAL REGISTRATION: ClinicalTrials.gov NCT03527433 . Registered on 17 May 2018 before starting participant enrollment.

Superior primary fascial closure rate and lower mortality after open abdomen using negative pressure wound therapy with continuous fascial traction.

BACKGROUND: Open abdomen (OA) is a useful option for treatment strategy in many acute abdominal catastrophes. A number of temporary abdominal closure (TAC) methods are used with limited number of comparative studies. The present study was done to examine risk factors for failed delayed primary fascial closure (DPFC) and risk factors for mortality in patients treated with OA. METHODS: This study was a multicenter retrospective analysis of the hospital records of all consecutive patients treated with OA during the years 2009 to 2016 at five tertiary referral hospitals and three secondary referral centers in Finland. RESULTS: Six hundred seventy-six patients treated with OA were included in the study. Vacuum-assisted closure with continuous mesh-mediated fascial traction (VACM) was the most popular TAC method used (N = 398, 59%) followed by VAC (N = 128, 19%), Bogota bag (N = 128, 19%), and self-designed methods (N = 22, 3%). In multivariate analysis, enteroatmospheric fistula and the number of needed TAC changes increased the risk for failed DPFC (odds ratio [OR], 8.9; 95% confidence interval [CI], 6.2-12.8; p < 0.001 and OR, 1.1; 95% CI, 1.0-1.3; p < 0.001, respectively). Instead, VACM and ruptured abdominal aortic aneurysm as cause for OA both decreased the risk for failed DPFC (OR, 0.1; 95% CI, 0.0-0.3; p < 0.001 and OR, 0.2; 95% CI, 0.1-0.7; p = 0.012). The overall mortality rate was 30%. In multivariate analysis for mortality, multiorgan dysfunction (OR, 2.4; 95% CI, 1.6-3.6; p < 0.001), and increasing age (OR, 4.5; 95% CI, 2.0-9.7; p < 0.001) predicted increased mortality. Institutional large annual patient volume (OR, 0.4; 95% CI, 0.3-0.6; p < 0.001) and ileus and postoperative peritonitis in comparison to severe acute pancreatitis associated with decreased mortality (OR, 0.2; 95% CI, 0.1-0.4; p < 0.001; OR, 0.5; 95% CI, 0.3-0.8; p = 0.009). Kaplan-Meier analysis showed increased survival in patients treated with VACM in comparison with other TAC methods (LogRank p = 0.019). CONCLUSION: We report superior role for VACM methodology in terms of successful primary fascial closure and increased survival in patients with OA. LEVEL OF EVIDENCE: Therapeutic/care management, level IV.

Negative Pressure Wound Therapy Compared to Petrolatum Gauze and a Bogota Bag to Manage Postoperative Midline Abdominal Wound Dehiscence: A Pilot, Nonrandomized Controlled Trial.

Treating postoperative abdominal wound dehiscence following abdominal surgery using negative pressure wound therapy (NPWT) has shown promising results. PURPOSE: A study was conducted to evaluate the efficacy of NPWT for fascial closure/cutaneous cover compared to non-NPWT treatment using petrolatum gauze and a Bogota bag in patients with postoperative laparotomy wound dehiscence. METHODS: A single center, prospective, nonrandomized pilot study was conducted. Using convenience sampling methods, consecutive patients on 6 different surgical units who were at least 18 years of age and who developed postoperative abdominal wound dehiscence following elective and emergency laparotomy from January 2017 to December 2018 were recruited. NPWT dressing with polyvinyl white foam sponge or loosely packed, saline-soaked petrolatum gauze followed by Bogota bag application were used and compared. Baseline patient demographics and history were collected, and patients were followed for an average of 6 months after surgery. Number of days until first signs of granulation tissue appearance, time until complete granulation tissue cover/fascial surgical closure, and hospital discharge were compared. Categorical variables (gender, comorbidities, presence or absence of stoma, exposure to prior radiotherapy) were expressed as proportions and analyzed using chi-squared test or Fischer's exact test. Continuous variables such as age, body mass index, albumin, postoperative hospital stay, and number of days required for decision for fascial closure were expressed as Mean ± standard deviation and analyzed using an independent t test or Mann Whitney U test based on whether the data followed normal distribution. Postoperative day of wound dehiscence, the number of days for the appearance of granulation tissue, and the number of NPWT placements required also were assessed using Mean ± standard deviation and analyzed using an independent t test. A P value <.05 was considered significant. RESULTS: Sixty (60) patients were included, but 4 in NPWT group and 10 in the non-NPWT group could not complete the study, leaving 26 patients in NPWT group and 20 patients in non-NPWT group. Demographic and surgical variables were not significantly different. Patients in both groups achieved complete wound coverage by surgical closure or healing by secondary intention. Days until first signs of granulation tissue (2.92 vs. 6.65; P <.001), number of days until fascial closure (15.50 vs. 29.50; P <.001), and length of postoperative hospital stay (24.30 vs. 37.90; P <.001) were significantly less in NPWT group. Two (2) patients (7.6%) in the NPWT developed a fistula during the 6-month follow-up period. No fistulas developed in the control group, and no intra-abdominal abscesses, ventral hernias, or wound dehiscence were reported in either group. CONCLUSION: Time until first signs of granulation tissue appearance and complete granulation tissue coverage was significantly shorter in the NPWT group, but time until definitive closure was not evaluated. Randomized, controlled clinical studies to compare definitive time to wound closure and long-term follow up to evaluate long-term complication rates, including the risk of developing fistulas, are warranted.

Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial.

BACKGROUND: Triclosan-coated sutures have been shown to reduce surgical-site infection (SSI) in emergent operation for fecal peritonitis. Barbed sutures provoke a homogeneous distribution of tension throughout the suture, implying better blood supply to the wound edges and healing. The aim of this study was to evaluate the effect, on SSI and evisceration, of using triclosan-coated and barbed sutures for fascial closure in patients undergoing emergent surgery. STUDY DESIGN: A prospective, randomized clinical trial was performed. Patients were randomized into 3 groups: those undergoing aponeurotic closure with triclosan-coated barbed suture (Stratafix Symmetric [Johnson & Johnson]), patients undergoing closure with triclosan-coated polydioxanone loop suture (PDS plus [Johnson & Johnson]), and patients undergoing closure with polydioxanone loop suture (PDS [Johnson & Johnson]). Primary investigated outcomes were SSI and evisceration rates during a follow-up period of 30 days. The primary analysis plan was based on a per-protocol approach. RESULTS: Incisional SSI was 6.4% (3 of 47) in the Stratafix Symmetric group, 8.9% (4 of 45) in the PDS plus group, and 23.4% (11 of 47) in PDS group (p = 0.03). The evisceration rate was 0% in Stratafix Symmetric, 8.9% (4 of 45) in PDS plus, and 12.8% (6 of 47) in PDS (p = 0.05). Median hospital stay was 4 days (range 2 to 14 days) in Stratafix Symmetric, 5 days (range 2 to 21 days) in PDS plus, and 8 days (range 2 to 60 days) in PDS (p = 0.012). The use of triclosan-coated sutures (Stratafix Symmetric and PDS plus) was associated with a lower risk of incisional SSI (p = 0.009), and the use of barbed suture was associated with a lower risk of evisceration (p = 0.019). Comparing Stratafix Symmetric with PDS plus, there were no significant differences in SSIs, but the evisceration rate was significantly higher in the PDS plus group (p = 0.036). CONCLUSIONS: The use of triclosan-coated sutures (Stratafix Symmetric and PDS plus) in emergent surgery reduces the incidence of incisional SSIs. The use of barbed sutures reduces the incidence of evisceration.

Immediate Closure of Abdominal Cavity with Biologic Mesh versus Temporary Abdominal Closure of Open Abdomen in Non-Trauma Emergency Patients (CLOSE-UP Study).

Background: In more than 10% of emergency laparotomies in non-trauma patients, primary fascial closure is not achievable because of excessive visceral edema, which leaves the patient with an open abdomen (OA). An OA harbors an inherent high risk of serious complications, and temporary closure devices are used to achieve delayed fascial closure. A potential new strategy in preventing OA is immediate closure during the emergency procedure with a non-crosslinked biologic mesh. Methods: This is a prospective comparative cohort feasibility study in 13 teaching hospitals in the Netherlands. Non-trauma patients who underwent emergency laparotomy in which regular sutured primary fascial closure was not achievable because of excessive intra-abdominal edema were eligible. In one cohort, Biomesh (n = 20), the abdominal cavity was immediately closed at the emergency laparotomy with a non-crosslinked biologic mesh. In a parallel cohort, Control (n = 20), the resulting OA was managed by temporary abdominal closure (TAC; inlay polyglactin [Vicryl™] mesh [n = 7]) or commercial (ABTheraTM) abdominal negative pressure therapy device (n = 13)). The primary end point was the proportion of closed abdominal cavities at 90 days. Results: At 90 days, 65% (13/20) of the abdominal cavities were closed in the Biomesh cohort versus 45% (9/20) in Controls (p = 0.204). In the Biomesh cohort, seven of 20 (35%) patients had at least one major complication versus 15 of 20 (75%) patients in the Control cohort (p = 0.011). Both the median number of intensive care unit (ICU) and mechanical ventilation days were significantly lower in the Biomesh cohort; one versus 10 (p = 0.002) and 0 versus four (p = 0.003) days, respectively. The number of abdominal reoperations was significantly lower in the Biomesh cohort (median 0 vs. two, p < 0.001; total number five vs. 44). Conclusions: If primary fascial closure cannot be achieved at the emergency laparotomy in non-trauma patients, immediate abdominal closure by use of a non-crosslinked biologic mesh prevents OA management. This results in a non-significant higher proportion of closed abdominal cavities at 90 days compared with OA management with TAC techniques, and in a significant reduction of major complications and reoperations, and a shorter ICU stay.

Suturable mesh better resists early laparotomy failure in a cyclic ball-burst model.

PURPOSE: The small bites surgical technique supported by the STITCH trial has been touted as a strategy for preventing early laparotomy dehiscence through greater force distribution at the suture-tissue interface. However, this hernia prevention strategy requires an alteration in the standard closure technique that has not been widely adopted in the USA. This study seeks to determine whether incorporating a mid-weight polypropylene mesh material into a hollow-bore surgical suture material will effectively increase the force distribution at the suture-tissue interface and potentially help prevent early laparotomy dehiscence in an ex vivo model. METHODS: A cyclic stress ball-burst model was used to compare suturable mesh (0 DuraMesh™) to conventional suture. After midline laparotomy, 28 porcine abdominal wall specimens were closed with either 0 DuraMesh™ or #1 polydioxanone double-loop suture. A custom 3D-printed ball-burst test apparatus was used to fatigue the repair on a MTS Bionix Load Frame. The tissue was repetitively stressed at a physiological force of 15-120 N cycled at a rate of 0.25 Hz for a total of 1000 repetitions, followed by a load to failure, and the maximal force was recorded. RESULTS: The mean maximal force at suture pull-through was significantly higher (p < 0.0095) in the 0 DuraMesh suture group (mean: 850.1 N) compared to the 1 PDS group (mean: 714.7 N). CONCLUSION: This ex vivo study suggests that using rational suture design to improve force distribution at the suture-tissue interface may be a viable strategy for preventing the suture pull-through that drives incisional hernia.

Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis.

BACKGROUND: Incisional hernia is a frequent complication after abdominal surgery. The aim of this study was to assess the efficacy of prophylactic mesh reinforcement (PMR) after midline laparotomy in reducing the incidence of incisional hernia. METHODS: A meta-analysis was conducted following PRISMA guidelines. The primary outcome was the incidence of incisional hernia after follow-up of at least 12 months. Secondary outcomes were postoperative complications. Only RCTs were included. A random-effects model was used for the meta-analysis, and trial sequential analysis was conducted. RESULTS: Twelve RCTs were included, comprising 1815 patients. The incidence of incisional hernia was significantly lower after PMR compared with sutured closure (risk ratio (RR) 0·35, 95 per cent c.i. 0·21 to 0·57; P < 0·001). Both onlay (RR 0·26, 0·11 to 0·67; P = 0·005) and retromuscular (RR 0·28, 0·10 to 0·82; P = 0·02) PMR led to a significant reduction in the rate of incisional hernia. The occurrence of seroma was higher in patients who had onlay PMR (RR 2·23, 1·10 to 4·52; P = 0·03). PMR did not result in an increased rate of surgical-site infection. CONCLUSION: PMR of a midline laparotomy using an onlay or retromuscular technique leads to a significant reduction in the rate of incisional hernia in high-risk patients. Individual risk factors should be taken into account to select patients who will benefit most. [Correction added on 19 February 2020, after first online publication: J. García Alamino has been amended to J. M. Garcia-Alamino].

ANTECEDENTES: La eventración (hernia incisional) es una complicación frecuente de la cirugía abdominal. El objetivo es evaluar la eficacia de la inserción de una malla profiláctica de refuerzo (prophylactic mesh reinforcement, PMR) después de la laparotomía media para reducir la incidencia de eventración. MÉTODOS: Se realizó un metaanálisis siguiendo las recomendaciones PRISMA. La variable principal fue la incidencia de eventración después de un seguimiento mínimo de 12 meses. Las variables secundarias fueron las complicaciones postoperatorias. Solo se incluyeron ensayos controlados aleatorizados. Se utilizó un modelo de efectos aleatorios para el metaanálisis y se realizó un análisis secuencial de los ensayos. RESULTADOS: Se incluyeron 12 ensayos aleatorizados y controlados con 1.815 pacientes. La incidencia de eventración fue significativamente menor después de la PMR en comparación con el cierre simple (riesgo relativo, RR 0,35; i.c. del 95%: 0,21-0,57, P < 0,0001). Hubo una reducción significativa de la tasa de eventración tanto si la PMR se colocó en posición supra-aponeurótica (RR 0,26; i.c. del 95% 0,11-0,67, P = 0,005) como retromuscular (RR 0,28; i.c. del 95% 0,0-0,82, P = 0,02). La aparición de seromas fue mayor en los pacientes con RPM supra-aponeurótica (RR 2,23; i.c. del 95% 1,10-4,52, P = 0,03). La PMR no conllevó una mayor tasa de infecciones de la herida quirúrgica. CONCLUSIÓN: Una PMR en una laparotomía de la línea media, tanto en posición supra-aponeurótica como retromuscular, reduce de forma significativa el desarrollo de eventraciones en pacientes de alto riesgo. Se deben considerar los factores de riesgo individuales para seleccionar a los pacientes que más puedan beneficiarse.

Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial.

BACKGROUND: Closure of an abdominal stoma, a common elective operation, is associated with frequent complications; one of the commonest and impactful is incisional hernia formation. We aimed to investigate whether biological mesh (collagen tissue matrix) can safely reduce the incidence of incisional hernias at the stoma closure site. METHODS: In this randomised controlled trial (ROCSS) done in 37 hospitals across three European countries (35 UK, one Denmark, one Netherlands), patients aged 18 years or older undergoing elective ileostomy or colostomy closure were randomly assigned using a computer-based algorithm in a 1:1 ratio to either biological mesh reinforcement or closure with sutures alone (control). Training in the novel technique was standardised across hospitals. Patients and outcome assessors were masked to treatment allocation. The primary outcome measure was occurrence of clinically detectable hernia 2 years after randomisation (intention to treat). A sample size of 790 patients was required to identify a 40% reduction (25% to 15%), with 90% power (15% drop-out rate). This study is registered with ClinicalTrials.gov, NCT02238964. FINDINGS: Between Nov 28, 2012, and Nov 11, 2015, of 1286 screened patients, 790 were randomly assigned. 394 (50%) patients were randomly assigned to mesh closure and 396 (50%) to standard closure. In the mesh group, 373 (95%) of 394 patients successfully received mesh and in the control group, three patients received mesh. The clinically detectable hernia rate, the primary outcome, at 2 years was 12% (39 of 323) in the mesh group and 20% (64 of 327) in the control group (adjusted relative risk [RR] 0·62, 95% CI 0·43-0·90; p=0·012). In 455 patients for whom 1 year postoperative CT scans were available, there was a lower radiologically defined hernia rate in mesh versus control groups (20 [9%] of 229 vs 47 [21%] of 226, adjusted RR 0·42, 95% CI 0·26-0·69; p<0·001). There was also a reduction in symptomatic hernia (16%, 52 of 329 vs 19%, 64 of 331; adjusted relative risk 0·83, 0·60-1·16; p=0·29) and surgical reintervention (12%, 42 of 344 vs 16%, 54 of 346: adjusted relative risk 0·78, 0·54-1·13; p=0·19) at 2 years, but this result did not reach statistical significance. No significant differences were seen in wound infection rate, seroma rate, quality of life, pain scores, or serious adverse events. INTERPRETATION: Reinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias. FUNDING: National Institute for Health Research Research for Patient Benefit and Allergan.