Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial.

Importance: Negative pressure wound therapy (NPWT) is an established treatment option, but there is no evidence of benefit for subcutaneous abdominal wound healing impairment (SAWHI). Objective: To evaluate the effectiveness and safety of NPWT for SAWHI after surgery in clinical practice. Design, Setting, and Participants: The multicenter, multinational, observer-blinded, randomized clinical SAWHI study enrolled patients between August 2, 2011, and January 31, 2018. The last follow-up date was June 11, 2018. The trial included 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands, and 539 consecutive, compliant adult patients with SAWHI after surgery without fascia dehiscence were randomly assigned to the treatment arms in a 1:1 ratio stratified by study site and wound size using a centralized web-based tool. A total of 507 study participants (NPWT, 256; CWT, 251) were assessed for the primary end point in the modified intention-to-treat (ITT) population. Interventions: Negative pressure wound therapy and conventional wound treatment (CWT). Main Outcomes and Measures: The primary outcome was time until wound closure (delayed primary closure or by secondary intention) within 42 days. Safety analysis comprised the adverse events (AEs). Secondary outcomes included wound closure rate, quality of life (SF-36), pain, and patient satisfaction. Results: Of the 507 study participants included in the modified ITT population, 287 were men (56.6%) (NPWT, 155 [60.5%] and CWT, 132 [52.6%]) and 220 were women (43.4%) (NPWT, 101 [39.5%] and CWT 119 [47.4%]). The median (IQR) age of the participants was 66 (18) years in the NPWT arm and 66 (20) years in the CWT arm. Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days) (difference, 3.0 days; 95% CI 1.6-4.4; P < .001). Wound closure rate within 42 days was significantly higher with NPWT (35.9%) than with CWT (21.5%) (difference, 14.4%; 95% CI, 6.6%-22.2%; P < .001). In the therapy-compliant population, excluding study participants with unauthorized treatment changes (NPWT, 22; CWT, 50), the risk for wound-related AEs was higher in the NPWT arm (risk ratio, 1.51; 95% CI, 0.99-2.35). Conclusions and Relevance: Negative pressure wound therapy is an effective treatment option for SAWHI after surgery; however, it causes more wound-related AEs. Trial Registration: ClinicalTrials.gov Identifier: NCT01528033.

Retrospective Analysis and Systematic Review of Isolated Traumatic Dissections of the Celiac Artery.

BACKGROUND: Isolated dissections of the celiac artery (CA) after blunt trauma are rarely described. This retrospective analysis and systematic review analyzes epidemiology, radiologic examinations, patterns of injuries, therapeutic measures, clinical courses, and outcomes. METHODS: Retrospective analysis of polytraumatized patients admitted between 1997 and 2012 to a trauma center level I. Systematic literature search was carried out on pubmed.gov, eurorad.org, and google.com. RESULTS: Isolated traumatic dissections of the CA had an incidence of 0.17% in a retrospective collective (n = 9). Mean age was 31.7 years in 6 male (66.7%) and 3 female (33.3%) patients. Systematic literature search identified 12 primary sources describing 13 males (100%) with a mean age of 41.3 years. Traffic accidents and falls were the most common causes of injury. An intimal flap (77.7%) and a thrombosed false lumen (59.1%) were the most common computed tomographic findings. Twenty-two patients were analyzed, and 16 patients were treated conservatively. The CA was bypassed in 2 symptomatic patients. One patient was treated with a stent. Two patients died because of massive bleeding, and 1 patient died because of liver failure. About 19 discharged patients were asymptomatic on follow-up. Long-term follow-up with magnetic resonance angiography showed stable dissections (n = 1), medium stenosis (n = 1), resolution of the dissection (n = 2), high-grade stenosis of the CA combined with a small pseudoaneurysm (n = 1), or occlusion of the CA with sufficient collateralization (n = 3). Pharmaceutical treatment was individualized with low-molecular-weight heparin, heparin, or warfarin, and acetylicsalicylic acid. CONCLUSIONS: Traumatic CA dissections are mostly caused by traffic accidents and falls. Visceral perfusion should be monitored clinically and radiologically. Beginning visceral ischemia requires early invasive treatment. Endovascular and open surgery are possible options. Benefits of specific pharmaceuticals are still up for debate. Follow-up via magnetic resonance imaging or computed tomography angiography is essential to rule out vascular complications. LEVEL OF EVIDENCE: III (Retrospective therapeutic study and systematic literature review).

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.