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.

Surgical outcome and midterm follow-up after transvaginal NOTES hybrid cholecystectomy: analysis of a prospective clinical series.

BACKGROUND: In the last 3 years transvaginal hybrid cholecystectomy (TV-ChE) has gained widespread interest as a potential alternative to laparoscopic cholecystectomy. However, substantial doubts about the transvaginal access and possibly associated complaints and complications have been raised. MATERIALS AND METHODS: This was a prospective clinical series of 80 consecutive female patients, nonrandomly chosen and without a control group, who underwent a TV-ChE. All patients were evaluated with special regard to outcome data such as surgical complications and gynecological complaints. Perioperative clinical data were collected and a gynecological examination was performed 3 weeks after surgery as well as a follow-up survey 3 months after surgery. RESULTS: The TV-ChE was performed in all patients without conversion to laparoscopy or open surgery. Two surgical complications occurred (1 urinary bladder injury and 1 case of bleeding). No infections of the surgical wound or any other complications were seen in the gynecological follow-up examination 3 weeks after the operation. After a follow-up of 3 months, 4% of the patients under 50 years of age reported slight and temporary problems after transvaginal cholecystectomy (dyspareunia and episodes of unclear lower abdominal pain), whereas such phenomena were seen in about 9% of women over 50 years of age (P < .05). A 33-year-old woman became pregnant 3 weeks after the operation. CONCLUSIONS: TV-ChE is a safe and less invasive surgical technique. Doubts about this operating technique with regard to an increased risk of infection or surgical complications as well as subsequent gynecological problems seem to be unfounded.