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.

Single-port versus standard laparoscopic resection for a gastric benign tumor in gastroscopic-laparoscopic rendezvous procedures using a laser-supported diaphanoscopy.

In this study, the standard laparoscopic technique versus the single-port approach was evaluated for the excision of benign gastric tumors using tissue-sparing laser-supported diaphanoscopy for localization. The first group consisted of 10 patients suffering from benign gastric tumors treated by standard laparoscopic resection. The second group included 10 patients treated using the single-port technique. All procedures were successfully completed. Histopathologic examination confirmed 15 cases of gastrointestinal stromal tumor, 3 cases of lipoma, 1 case of leiomyoma, and 1 case of high-grade dysplasia. There was no statistically significant difference for the operation times between both groups. Comparison of the largest and smallest resection margins achieved using the standard laparoscopic technique and single-port techniques showed no statistically significant differences between the groups. During follow-up, all patients were evaluated using the total body image and cosmesis questionnaire. Although scores of all body-image functions were similar, independent of laparoscopic technique, scores of all cosmetic functions in patients operated using the single-port technique showed a statistically significant higher degree of satisfaction with the scar (P<0185). The postoperative pain scores evaluated by the visual analog scale score were not significantly different between 2 groups. The single-port technique was found to be a feasible option for the resection of submucosal or mucosal tumors. However, this method is not intended to replace standard laparoscopic resections.