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Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions. We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052. Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31–0·87; p=0·0131). Rates of adverse events did not differ significantly between groups. Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions. Erasmus University Medical Center and Ethicon.

Background Surgical site infection (SSI) after spinal surgery is a devastating complication. Various methods of skin closure are used in spinal surgery, but the optimal skin-closure method remains unclear. A recent report recommended against the use of metal staples for skin closure in orthopedic surgery. 2-Octyl-cyanoacrylate (Dermabond; Ethicon, NJ, USA) has been widely applied for wound closure in various surgeries. In this cohort study, we assessed the rate of SSI in spinal surgery using metal staples and 2-octyl-cyanoacrylate for wound closure. Methods This study enrolled 609 consecutive patients undergoing spinal surgery in our hospital. From April 2007 to March 2010 surgical wounds were closed with metal staples (group 1, n  = 294). From April 2010 to February 2012 skin closure was performed using 2-octyl-cyanoacrylate (group 2, n  = 315). We assessed the rate of SSI using these two different methods of wound closure. Prospective study of the time and cost evaluation of wound closure was performed between two groups. Results Patients in the 2-octyl-cyanoacrylate group had more risk factors for SSI than those in the metal-staple group. Nonetheless, eight patients in the metal-staple group compared with none in the 2-octyl-cyanoacrylate group acquired SSIs ( p  < 0.01). The closure of the wound in length of 10 cm with 2-octyl-cyanoacrylate could save 28 s and $13.5. Conclusions This study reveals that in spinal surgery, wound closure using 2-octyl-cyanoacrylate was associated with a lower rate of SSI than wound closure with staples. Moreover, the use of 2-octyl-cyanoacrylate has a more time saving effect and cost-effectiveness than the use of staples in wound closure of 10 cm in length.

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. 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. 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. 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. National Institute for Health Research Research for Patient Benefit and Allergan.

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. 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. 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). 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. Johnson & Johnson Medical Limited.

PurposeTo compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial.MethodsPatients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale were included. The outcomes analyzed were the incidence of AWD and surgical site occurrence (SSO).Results239 patients were included: 121 mesh group and 118 RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p = 0.56, RR = 0.69, 95% CI = 0.22–2.13) in the per-protocol analysis. The median time of presentation was 6 days. The 95% CI (−0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications did not significantly differ between the two groups: the mesh group (27, 22.3%) and the RTL group (16, 12.8%) (p = 0.09, RR (95% CI) = 1.64 (0.93–2.89)).ConclusionThe use of the RTL technique for preventing AWD was not inferior to the use of mesh in the onlay position, nor did it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).

PurposeThe short-stitch technique for midline laparotomy closure has been shown to reduce hernia rates, but long stitches remain the standard of care and the effect of the short-stitch technique on short-term results is not well known. The aim of this study was to compare the two techniques, using an ultra-long-term absorbable elastic suture material. MethodsFollowing elective midline laparotomy, 425 patients in 9 centres were randomised to receive wound closure using the short-stitch (USP 2-0 single thread, n = 215) or long-stitch (USP 1 double loop, n = 210) technique with a poly-4-hydroxybutyrate-based suture material (Monomax®). Here, we report short-term surgical outcomes. ResultsAt 30 (+10) days postoperatively, 3 (1.40%) of 215 patients in the short-stitch group and 10 (4.76%) of 210 patients in the long-stitch group had developed burst abdomen [OR 0.2830 (0.0768–1.0433), p = 0.0513]. Ruptured suture, seroma and hematoma and other wound healing disorders occurred in small numbers without differences between groups. In a planned Cox proportional hazard model for burst abdomen, the short-stitch group had a significantly lower risk [HR 0.1783 (0.0379–0.6617), p = 0.0115]. ConclusionsAlthough this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique.Trial registryNCT01965249, registered October 18, 2013.

Purpose Suturing with small stitches instead of with large reduces the risk for surgical site infection and incisional hernia in continuously closed midline abdominal incisions. The purpose was to analyse if using small stitches generated cost savings. Methods Between 2001 and 2006 closure of midline incisions using small stitches was, in a randomised trial, compared with the use of large stitches. In 2011 all patients included in the randomised trial, who until then, had had an incisional hernia repair, were recorded. The cost for an open incisional hernia repair with mesh reinforcement during 2010 was calculated. The analysis included both direct and indirect costs. Results Of 321 patients closed with small stitches incisional hernia occurred in 11 and 3 needed repair. Of 370 patients closed with large stitches herniation occurred in 45 and 14 needed repair. The direct cost per hernia repair was 59,909 Swedish krona (SEK) and the indirect cost was 26,348 SEK. Suturing time with small stitches was 4.6 min longer, increasing the cost for the index operation by 1,076 SEK. From the societal perspective (direct and indirect costs), using small stitches generated a cost reduction of 1,339 SEK for each patient. From the perspective of the public payer (direct costs) the cost reduction was 601 SEK. Using small stitches generated cost savings from a societal perspective if the suturing time was not prolonged over 10.3 min. Conclusions Using small stitches when closing midline abdominal incisions with a continuous single-layer technique generates cost savings.

Prevention of surgical site infections (SSIs) can improve surgical quality through reductions in morbidity and cost. We sought to determine whether the abdominal closure protocol, in isolation, decreases SSI at an academic teaching hospital. Adult patients undergoing laparotomy were prospectively randomized to an abdominal closure protocol, which includes unused sterile instruments and equipment at fascial closure, or usual care. A 30-day SSI rates were compared. General surgery, colorectal, urology, or gynecologic oncology patients undergoing anticipated wound classification II cases were eligible. Overall SSI rates were 11.6% in patients randomized to protocol closure vs 12.4% for usual care (total n = 233; P = .85). The abdominal closure protocol and usual care groups had similar rates of superficial (4.5% vs 4.1%; P = .9), deep (.9% vs 0%, P = .3), organ-space SSI rates (6.2% vs 8.3%, P = .55), and wound dehiscence (2.7% vs 5.3%; P = .24). An abdominal closure protocol did not decrease the rate of SSI and is likely not a key intervention for SSI reduction. •A closing tray used at fascial closure does not decrease surgical site infection.•This study was a prospective randomized quality improvement trial.•A total of 233 patients were randomized to the closing tray or usual care.

BackgroundSeveral 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.MethodsIn 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.ResultsBetween 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].ConclusionsTachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.

Temporary abdominal closure (TAC) techniques are routinely used in the open abdomen. Ideally, they should prevent evisceration, aid in removal of unwanted fluid from the peritoneal cavity, facilitate in achieving safe definitive fascial closure, as well as prevent the development of intra-abdominal complications. TAC techniques used in the open abdomen were compared with negative pressure wound therapy (NPWT) to identify which was superior. A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines involving Medline, Excerpta Medica, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, and Clinicaltrials.gov. All studies describing TAC technique use in the open abdomen were eligible for inclusion. Data were analyzed per TAC technique in the form of a meta-analysis. A total of 225 articles were included in the final analysis. A meta-analysis involving only randomized controlled trials showed that NPWT with continuous fascial closure was superior to NPWT alone for definitive fascial closure [mean difference (MD): 35% ± 23%; P = 0.0044]. A subsequent meta-analysis involving all included studies confirmed its superiority across outcomes for definitive fascial closure (MD: 19% ± 3%; P < 0.0001), perioperative (MD: -4.0% ± 2.4%; P = 0.0013) and in-hospital (MD: -5.0% ± 2.9%; P = 0.0013) mortality, entero-atmospheric fistula (MD: 22.0% ± 1.8%; P = 0.0041), ventral hernia (MD: -4.0% ± 2.4%; P = 0.0010), and intra-abdominal abscess (MD: -3.1% ± 2.1%; P = 0.0044). Therefore, it was concluded that NPWT with continuous fascial traction is superior to NPWT alone.