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Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial.

ABSTRACT: BACKGROUND:Surgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the literature. It is unclear whether the use of coated suture material for skin closure reduces the risk of SSI. In line with in-vitro results, we hypothesize that the use of antibacterial skin sutures (triclosan-coated poliglecaprone 25) reduces the rate of SSI after open abdominal surgery. METHODS/DESIGN:To prevent SSI, triclosan-coated poliglecaprone 25 sutures will be tested against un-coated suture material for skin closure after elective open abdominal surgery of 364 patients. The study is planned as a single-center, prospective randomized controlled trial. Patients will be followed for 30?days after surgery to detect and document wound complications. The rate of SSI after 30?days will be analyzed in both groups. DISCUSSION:If we can confirm the proposed hypothesis in our study, this could be a promising and feasible approach to lower SSI after open abdominal surgery. By lowering the rate of SSI this might offer a cost-saving and morbidity-reducing procedure. TRIAL REGISTRATION:German Clinical Trials Register, DRKS00010047 . Registered on 05.01.2017.

SUBMITTER: Matz D

PROVIDER: S-EPMC6604458 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial.

Matz Daniel D Teuteberg Saskia S Wiencierz Andrea A Soysal Savas Deniz SD Heizmann Oleg O

Trials 20190702 1

<h4>Background</h4>Surgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the literature. It is unclear whether the use of coated suture material for skin closure reduces the risk of SSI. In line with in-vitro results, we hypothesize that the use of antibacterial skin sutures (triclosan-coated poliglecaprone 25) reduces the rate of SSI after open abd ...[more]

PMID: 31266520

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Project description:ImportanceSurgical site infections remain one of the most frequent complications following abdominal surgery and cause substantial costs, morbidity and mortality.ObjectiveTo assess the effectiveness of wound edge protectors in open abdominal surgery in reducing surgical site infections.Evidence reviewA systematic literature search was conducted according to a prespecified review protocol in a variety of data-bases combined with hand-searches for randomized controlled trials on wound edge protectors in patients undergoing laparotomy. A qualitative and quantitative analysis of included trials was conducted.FindingsWe identified 16 randomized controlled trials including 3695 patients investigating wound edge protectors published between 1972 and 2014. Critical appraisal uncovered a number of methodological flaws, predominantly in the older trials. Wound edge protectors significantly reduced the rate of surgical site infections (risk ratio 0.65; 95%CI, 0.51-0.83; p = 0.0007; I2 = 52%). The results were robust in a number of sensitivity analyses. A similar effect size was found in the subgroup of patients undergoing colorectal surgery (risk ratio 0.65; 95%CI, 0.44-0.97; p = 0.04; I2 = 56%). Of the two common types of wound protectors double ring devices were found to exhibit a greater protective effect (risk ratio 0.29; 95%CI, 0.15-0.55) than single-ring devices (risk ratio 0.71; 95%CI, 0.54-0.92), but this might largely be due to the lower quality of available data for double-ring devices. Exploratory subgroup analyses for the degree of contamination showed a larger protective effect in contaminated cases (0.44; 95%CI, 0.28-0.67; p = 0.0002, I2 = 23%) than in clean-contaminated surgeries (0.72, 95%CI, 0.57-0.91; p = 0.005; I2 = 46%) and a strong effect on the reduction of superficial surgical site infections (risk ratio 0.45; 95%CI, 0.24-0.82; p = 0.001; I2 = 72%).Conclusions and relevanceWound edge protectors significantly reduce the rate of surgical site infections in open abdominal surgery. Further trials are needed to explore their effectiveness in different risk constellations.

Project description:Importance:Knowledge regarding the long-term outcomes of elective treatment of abdominal aortic aneurysm (AAA) using endovascular aortic repair (EVAR) is increasing. However, data with greater than 10 years' follow-up remain sparse and are lacking from population-based studies. Objective:To determine the long-term outcomes of EVAR compared with open surgical repair (OSR) for elective treatment of AAA. Design, Setting, and Participants:This retrospective, population-based cohort study used linked administrative health data from Ontario, Canada, to identify all patients 40 years and older who underwent elective EVAR or OSR for AAA repair from April 1, 2003, to March 31, 2016, with follow-up terminating on March 31, 2017. A total of 17 683 patients were identified using validated procedure and billing codes and were propensity score matched. Analysis was conducted from June 26, 2018, to January 16, 2019. Exposures:Elective EVAR or OSR for AAA. Main Outcomes and Measures:The primary outcome was overall survival. Secondary outcomes were major adverse cardiovascular event-free survival, defined as being free of death, myocardial infarction, or stroke; reintervention; and secondary rupture. Results:Among 17 683 patients who received elective AAA repairs (mean [SD] age, 72.6 [7.8] years; 14 286 [80.8%] men), 6100 (34.5%) underwent EVAR and 11 583 (65.5%) underwent OSR. From these patients, 4010 well-balanced propensity score-matched pairs of patients were defined, with a mean (SD) age of 73.0 (7.6) years and 6583 (82.1%) men. In the matched cohort, the mean (SD) follow-up was 4.4 (2.7) years, and maximum follow-up was 13.8 years. The overall median survival was 8.9 years. Compared with OSR, EVAR was associated with a higher survival rate up to 1 year after repair (91.0% [95% CI, 90.1%-91.9%] vs 94.0% [95% CI, 93.3%-94.7%]) and a higher major adverse cardiovascular event-free survival rate up to 4 years after repair (69.9% [95% CI, 68.3%-71.3%] vs 72.9% [95% CI, 71.4%-74.4%]). Cumulative incidence of reintervention was higher among patients who underwent EVAR compared with those who underwent OSR at the 7-year follow-up (45.9% [95% CI, 44.1%-47.8%] vs 42.2% [95% CI, 40.4%-44.0%]). Survival analyses demonstrated no statistically significant differences in long-term survival, reintervention, and secondary rupture for patients who underwent EVAR compared with those who underwent OSR. Kaplan-Meier analysis suggested superior long-term major adverse cardiovascular event-free survival among patients who underwent EVAR compared with those who underwent OSR (32.6% [95% CI, 26.9%-38.4%] vs 14.1% [95% CI, 4.0%-30.4%]; stratified log-rank P < .001) during a maximum follow-up of 13.8 years. Conclusions and Relevance:Endovascular aortic repair was not associated with a difference in long-term survival during more than 13 years' maximum follow-up. The reasons for these findings will require studies to consider specific graft makes and models, adherence to instructions for use, and types and reasons for reintervention.

Project description:BackgroundSurgical site infections (SSIs) after elective orthopaedic surgery are very stressful for patients due to frequent rehospitalizations with reoperations and poorer functional outcomes. Prevention of such events is therefore crucial. Although an evidence-based consensus is still lacking, preoperative decolonization could decrease SSI. Specifically, more information is needed about the effect of a preoperative decolonization procedure on SSI proportions in both Staphylococcus aureus carriers and non-S. aureus carriers after general orthopaedic surgery.Questions/purposesOur study addressed the following questions: (1) Does preoperative decolonization reduce the risk of SSI after general elective orthopaedic surgery in patients colonized with S. aureus? (2) Does preoperative decolonization reduce the risk of SSI among patients who are not colonized with S. aureus?MethodsIn this prospective, randomized, single-blinded trial, we recruited patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland. Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled. Patients were allocated into either the S. aureus carrier group (35%, 465 of 1318 patients) or the noncarrier group (65%, 853 of 1318 patients) according to screening culture results. In the S. aureus group, 232 patients were allocated to the intervention arm and 233 were allocated to the control arm. Intervention was 5 days of daily chlorhexidine showers and mupirocin nasal ointment twice a day. Of the 853 noncarriers, 426 were allocated to the intervention arm and 427 were allocated to the control arm. All patients in both groups were analyzed in an intention-to-treat manner. The primary endpoint was SSI occurrence at 90 days postoperative and the secondary endpoint was SSI occurrence at 30 days postoperative.The initial sample size calculation was made for the S. aureus carrier group. Based on the literature review, a 4% proportion of SSI was expected in the control group. Thus, 726 carriers would have been needed to detect a relative risk reduction of 80% with a power of 80% at a two-sided α-error of 0.048 (adjusted for interim analysis). Assuming carrier prevalence of 27%, 2690 patients would have been needed in total. An interim analysis was performed after including half of the targeted S. aureus carriers (363 of 726). Based on the low infection rate in the control group (one of 179), a new sample size of 15,000 patients would have been needed. This was deemed not feasible and the trial was stopped prematurely.ResultsAmong carriers, there was no difference in the risk of SSI between the intervention and control arms (decolonized SSI risk: 0.4% [one of 232], control SSI risk: 0.4% [one of 233], risk difference: 0.0% [95% CI -1.2% to 1.2%], stratified for randomization stratification factors; p > 0.999). For noncarriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference: -0.0% [95% CI -0.7 to 0.6]; p = 0.973).ConclusionsWe found no difference in the risk of SSI between the decolonization and control groups, both in S. aureus carriers and noncarriers. Because of the low event numbers, no definite conclusion about efficacy of routine preoperative decolonization can be drawn. The results, however, may be helpful in future meta-analyses.Level of evidenceLevel II, therapeutic study.

Project description:ObjectivesFor years, many efforts have been invested to prepare patients, in particular, those with reduced physical and psychic status, much better to provide and finally achieve better outocme if there is time available to provide several beneficial measures.MethodsTherefore, the objective was to illustrate the concept and various single elements of a complex prehabilitation concept based on (i) selective references from the medical literature and (ii) own clinical experiences from clinical practice in general and abdominal surgery.ResultsPrehabiliation can be considered the solution of the efforts to improve preoperative status for patients in a disadvantageous status for almost all types of surgery and all other operative and/or interventional procedures. It is the targeted process to improve individual functionality and organ function before a planned (elective) surgical intervention; P. comprises basically nutritional, physical and psychological measures; P. focusses especially onto the elderly, frail and malnourished patients before a planned surgical intervention; the overall aim is to significantly improve final outcome characterized by shorter length of stay, lower complication rate and mortality as well as cost efficiency; P. is especially important in cancer surgery, in which the beneficial effects can be particularly implemented; P. programs and/or "Standard Operating Protocols" (SOP) may help to establish and materialize its single aspects and enhanced recovery after surgery (ERAS). There is still further potential to reliably establish and to utilize the options of prehabilitation measures as listed above.ConclusionsPrehabiliation is an indispensable aspect in today's preparation for elective surgery, which needs to become obligatory part of the preparation measures to planned surgical interventions, which can further contribute to a better final outcome and ERAS as well as, in addtion, needs to be further developed and accomplished.

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Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial.

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Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial.

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