Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650).
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ABSTRACT: Objectives
To assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) rate after caesarian delivery (CD).Study design
Three hundred eighty patients were randomly assigned to closure with polyglactin non coated suture VICRYL, or with polyglactin coated suture VICRYL Plus after caesarian section. The primary outcome was the rate of SSIs within 30 days after surgery and secondary outcomes were the rate of wound healing complications.Results
SSI rate was 2.5% in Triclosan group compared to 8.1% with non-coated suture. Use of Triclosan coated suture (TCS) was associated with 69% reduction in SSI rate (p = 0.037; ORa:0.294; 95% CI:0.094-0.921). The use of Triclosan coated suture was associated with statistically lower risk of wound oedema (2.5% vs 10%), (p = 0.019; OR:0.595), dehiscence (3.8% vs 10.6%), (p = 0.023; OR:0.316) and hematoma (p = 0.035; OR:0.423).Conclusion
Our results confirm the effectiveness of Triclosan coated suture in reducing SSI rate and wound healing disturbances.Trial registration
Registered at ClinicalTrials.gov / ID (NCT05330650).
SUBMITTER: Mbarki W
PROVIDER: S-EPMC9754295 | biostudies-literature | 2022
REPOSITORIES: biostudies-literature
Publications
Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650).
Mbarki Wael W Bettaieb Hajer H Souayeh Nesrine N Laabidi Idriss I Rouis Hadhemi H Halouani Soumaya S Boufarghine Rami R Bouyahia Maha M Bouhmida Rahma R Ouederni Mariem M Ben Amor Anissa A Chermiti Amal A Laamiri Hadir H Lika Amira A Chaibi Imen I Oueslati Hedhili H Hsayaoui Najeh N Mbarki Chaouki C
PloS one 20221215 12
<h4>Objectives</h4>To assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) rate after caesarian delivery (CD).<h4>Study design</h4>Three hundred eighty patients were randomly assigned to closure with polyglactin non coated suture VICRYL, or with polyglactin coated suture VICRYL Plus after caesarian section. The primary outcome was the rate of SSIs within 30 days after surgery and secondary outcomes were the rate of wound healing complications.<h4>Result ...[more]
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Project description:PurposeWe assessed clinical outcomes of patients undergoing open hernia repair using STRATAFIX™ Symmetric, a barbed triclosan-coated suture (TCS; Ethicon), versus conventional polydioxanone suture (PDS) for abdominal wall closure.MethodsThis single-center retrospective cohort study identified patients undergoing hernia repair. The site used PDS from 2013 to 2016 and switched exclusively to barbed TCS in 2017. Outcomes were assessed at 30, 60, and 90 days. Multivariate regression analyses and Cox proportional hazards models were used.ResultsOf 821 hernia repairs, 446 used barbed TCS and 375 used conventional PDS. Surgical site infections (SSIs) were significantly less frequent with barbed TCS (60 days, 5.9% vs. 11.4%; P = 0.0083; 90 days, 5.9% vs. 11.7%; P = 0.006) and this remained consistent after multivariate adjustment (60 days, OR [95% CI]: 0.5 [0.3-0.9]; 90 days, 0.5 [0.3-0.9]). Among patients with SSI, deep SSIs were less frequent with barbed TCS (60 days, 9.1% vs. 35.7%; P = 0.022; 90 days, 9.1% vs. 34.9%; P = 0.0252). Barbed TCS significantly reduced the risk of perioperative complications (HR [95% CI]: 0.5[0.3-0.8]; P = 0.0058). Hospital length of stay was 2.5 days shorter with barbed TCS (mean [95% CI]: 5.7[4.9-6.6] vs. 8.2[7.3-9.1] days; P < 0.0001). No differences in reoperation rate over time were observed by type of suture (HR[95% CI]:1.3 [0.5-3.4]; P = 0.4793).ConclusionsThis study showed that patients who underwent open hernia repair appeared to recover equally well regardless of the suture type. In addition, the use of barbed TCS was associated with significantly reduced risk of perioperative complications and hospital length of stay.
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Project description:BackgroundAdjustable sutures increase the success rate of strabismus surgery. However, the optimal timing of postoperative suture adjustment remains controversial. This trial was aimed at comparing the surgical outcomes and pain scores of early or 2 - 4 h and delayed or 24 h postoperative suture adjustment in adult patients undergoing strabismus surgery.MethodsAn open-label, prospective, randomized, comparative interventional study was performed in consecutive adult patients scheduled for eye muscle surgery. Patients were randomized into two groups: the early group, with suture adjustment 2 - 4 h postoperatively, and the delayed group, with suture adjustment 24 h postoperatively. Subjective pain scores during the adjustment were also analyzed. The angles of misalignment at 1 and 3 months and the success rate at 3 months postoperatively were compared.ResultsForty-five (90%) patients completed the follow-up, including 23 (92%) in the early adjustment group and 22 (88%) in the delayed adjustment group, with a mean (standard deviation) age of 25.6 (9.5) years and a male-to-female ratio of 46.7:53.3. Thirty patients (66.7%) had exotropia, and 15 (33.3%) patients had esotropia. Both groups had comparable baseline characteristics (all P > 0.05). The mean pain scores during adjustment did not differ significantly between groups (P > 0.05). The postoperative angles of alignment were comparable between the groups before suture adjustment and at the 1- and 3-month follow-ups (all P > 0.05). The success rate in the early adjustment group was slightly higher (87.0% versus 63.6%), but the difference was not statistically significant (P > 0.05). The success rate was comparable between the groups in patients with esotropia or exotropia (both P > 0.05).ConclusionsAlthough the early adjustment group had a slightly higher success rate, the difference was not significant. Both groups had comparable subjective pain scores during adjustment, final motor alignment, or success rate. Future clinical trials should be performed different time intervals for postoperative suture adjustment, and subjective and objective outcomes, such as diplopia and stereopsis, should be compared between patients with a first strabismus surgery and those who underwent reoperation. This could better resolve the persistent controversy related to the optimal time for suture adjustment.
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Project description:BackgroundWound healing and scar quality after trauma are subject to impairment through excessive wound healing, chronic wound or even surgical site infections. Optimizing the process of scar formation and skin healing is crucial in virtually all fields of medicine. In this regard, we tested the possible usage and advantages of titanium coated suture material.MethodsWe performed a prospective observational cohort study including 30 patients who underwent soft tissue reconstruction. One half of the donor flap site was sutured with titanium coated suture material, while the other half was closed with non-coated sutures. Scar quality of the donor flap site was assessed by photographs and POSAS scores on days 2-5, 14, 42, 72 and 180 postoperatively.ResultsNo difference between the titanium coated sutures and non-coated sutures was seen in the POSAS assessment, neither for the patient scale at 14, 42, 72 and 180 days, nor for the observer scale on the same dates. Comorbidities like diabetes, chronic renal failure and smoking as well as the BMI of each patient affected the wound healing process to an equal degree on both sides of the suture.ConclusionsNo difference between the titanium coated and non-titanium-coated suture material was seen in the POSAS assessment in regard to scar quality and wound healing. The titanium-coated suture material can be considered to be equally as effective and safe in all qualities as the non-titanium-coated suture material, even in patients with comorbidities. Clinical trial register This study is registered at the German Clinical Trials Register (DRKS) under the registration number DRKS00021767. ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021767 ).
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Project description:BackgroundSurgical site infections (SSIs) are one of the most frequently reported types of hospital-acquired infection and are associated with substantial clinical and economic burden.AimTo assess the incidence of SSIs and analyze contributing risk factors in a real-world Spanish hospital setting before and after the implementation of triclosan-coated sutures (TCS).MethodsA prospective, observational study was conducted at Hospital Clínico Universitario de Santiago de Compostela, Spain. Enrolled patients underwent surgery in the following specialties: general surgery, urology, neurosurgery, gynaecology, and traumatology. The primary outcome of the study was SSI incidence, assessed at a 30-day follow-up. Secondary outcomes were length of hospital stay, and readmission, reintervention, and mortality rates, also at 30 days.Findings5,081 patients were included in the study, of which 2,591 were treated using non-coated sutures (NCS) and 2,490 using TCS. After adjusting for potential confounders, TCS significantly reduced SSI rate by 36%, compared with NCS (odds ratio [OR]: 0.64; 95% confidence interval [CI]: 0.48-0.85; P<0.003). When stratified by wound classification, a statistically significant reduction in SSI incidence, in favour of TCS use, was observed for Class IV (dirty) wounds (35.6% versus 22.7% for NCS and TCS, respectively; OR: 0.53; 95% CI: 0.31-0.90).ConclusionThe use of TCS reduced SSI risk when compared with NCS. This reduction was significant for Class IV wounds, providing evidence that supports the use of TCS for this type of wound.
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Project description:Dexmedetomidine and magnesium sulfate have been used in anesthesia as adjuvant to provide hemodynamic stability and anesthetic agents sparing effect. We compared these effects of dexmedetomidine and magnesium sulfate in spine surgeries.Ninety patients were randomly assigned to three groups. Group D received dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.5 µg/kg/h throughout the surgery. Group M received magnesium sulfate loading dose 50 mg/kg over a period of 15 minutes and maintenance 15 mg/kg/h throughout the surgery. Group C received same volume of normal saline. Heart rate (HR) and blood pressure values were recorded at various intervals. The induction and maintenance doses of anesthetics and recovery parameters were also recorded.Heart rate in group D and group M were significantly decreased (p<0.05) during the whole intraoperative period compared to preoperative values. There was a significant difference in HR values between group C, D and M, during the whole intraoperaive period (p<0.05). Blood pressure values were statistically significantly lower in the group D and group M compared to group C after intubation and all time observations of surgery (p<0.05). Both drugs reduced the anesthetic agent's requirement during surgery. However, the recovery parameters were statistically significant increase with magnesium sulphate compared to dexmedetomidine and control groups.Dexmedetomidine is more effective than magnesium sulfate for maintaining the hemodynamic stability in spine surgeries. Both these drugs also reduce the requirements of anesthetic agents. Recovery from dexmedetomidine is as rapid as control group compared to magnesium sulfate.
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Project description:BackgroundCoated polyglactin 910 suture with chlorhexidine (NEOSORB® Plus) has recently been developed to imbue the parent suture with antibacterial activity against organisms that commonly cause surgical site infections (SSI). This prospective, single-blinded, randomized trial, was performed to compare the intraoperative handling and wound healing characteristics of NEOSORB® Plus with those of the traditional polyglactin 910 suture (NEOSORB®) in urologic surgery patients.MethodsPatients (aged 19 to 80 years, n = 100) were randomized in a 1:1 ratio for treatment with either NEOSORB® Plus or NEOSORB®, and stratified into an open surgery or a minimally invasive surgery group. The primary endpoint was the assessment of overall intraoperative handling of the sutures. Secondary endpoints included specific intraoperative handling measures and wound healing characteristics. Wound healing was assessed at one and 11 days after surgery. Cumulative skin infection, seroma, and suture sinus events within 30 days after surgery were also evaluated.ResultsA total of 96 patients were included, with 47 patients in the NEOSORB® Plus group and 49 patients in the NEOSORB® group. Scores for intraoperative handling were favorable and were not significantly different between the two suture groups. Wound healing characteristics were also comparable. The incidence of adverse events was 13.6%, although none were deemed attributable to the suture, and no difference was observed between the two groups.ConclusionsNEOSORB® Plus is not inferior to traditional sutures in terms of intraoperative handling and wound healing, potentially making NEOSORB® Plus a beneficial alternative for patients at increased risk of SSI.Trial registrationClinicalTrials.gov: NCT02431039 . Trial registration date 14 August 2015.
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Project description:BackgroundMost retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later.ObjectiveThis study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals.Study designAuthor guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals.ResultsMost studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals.ConclusionProspective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.
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Project description:The incidence of surgical site infection (SSI) after open vein harvesting in coronary artery bypass grafting (CABG) patients ranges in different studies between 2 and 20%. Triclosan is an antibacterial substance that reduces the growth of bacteria by inhibiting fatty acid synthesis. We hypothesized that wound closure with triclosan-coated sutures would reduce SSI after open vein harvesting.An investigator-initiated prospective randomized double-blind single-centre study was performed with 374 patients, randomized to subcutaneous and intracutaneous leg-wound closure with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Somerville, NJ, USA) (n = 184) or identical sutures without triclosan (n = 190) from the same manufacturer. All patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). Primary endpoint was SSI within 60 days after surgery according to the definition of Center for Disease Control. Predefined secondary endpoints included culture-proven and antibiotic-treated SSI.The primary endpoint occurred in 23 patients (12.5%) with triclosan-coated sutures and in 38 patients (20.0%) in the group without triclosan (P = 0.0497, risk ratio 0.63, (95% confidence interval 0.39-1.00). Corresponding figures for culture-proven infections were 7.6 vs 12.1%, (P = 0.15), and for antibiotic-treated infections, 10.9 vs 18.4%, (P = 0.039). Staphylococcus aureus and coagulase-negative staphylococci were the most common pathogens in both groups. Insulin-treated diabetes and vein-harvesting time were associated with SSI after vein harvesting.Leg-wound closure with triclosan-coated sutures in CABG patients reduces SSIs after open vein harvesting. (ClinicalTrials.gov number NCT01212315).
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Project description:Background Liver surgery is the standard of care for primary and many secondary liver tumors. Due to variability and complexity in liver anatomy preoperative imaging is necessary to determine resectability and for planning the surgical strategy. In the last few years, computer-assisted resection planning has been introduced in liver surgery. Aim of this trial was the evaluation of computer-assisted three-dimensional (3D)-navigation for liver surgery. Methods This study was a prospective randomized-controlled pilot trial and patients were randomized in navigated or non-navigated group. Primary end point was the quotient of intraoperative resected volume and planned resection volume. Secondary end points included operation time, resection margin and postoperative complications. 3D reconstructions were performed with MeVis Distant Services (MeVis AG, Bremen, Germany). The navigation system CAS-One Liver (CAScination AG, Bern, Switzerland) was used for intraoperative computer-assisted 3D-navigation. Results The data of 16 patients with 20 liver tumors were used in this analysis. Of these, 8 liver tumors were resected with the utilization of intraoperative navigation. Two postoperative complications were classified grade IIIa or higher. There was no difference in duration of operation (189 vs. 180 min, P=0.970), rate of postoperative complications (n=1 vs. n=1, P=0.696) and length of hospital stay (9 vs. 7 days, P=0.368) between the two groups. Minimal resection margin (0.15 vs. 0.40 cm, P=0.384) and quotient of planned to intraoperative resection volume (0.94 vs. 1.11, P=0.305) were also similar. Conclusions Intraoperative navigation is a technology that can be safely used during liver resection. Surgical accuracy is not yet superior to the current standard of intraoperative orientation. Further technological advances with suitable deformation algorithms and augmented reality systems will enable a further improvement of the technical feasibility.
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Project description:BackgroundCytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy for pseudomyxoma peritonei (PMP) is associated with excessive bleeding and acquired fibrinogen deficiency. Maintaining plasma fibrinogen may support hemostasis.ObjectivesTo compare hemostatic efficacy and safety of human fibrinogen concentrate (HFC) vs cryoprecipitate as fibrinogen sources for bleeding patients with acquired fibrinogen deficiency undergoing PMP CRS.MethodsFORMA-05 was an off-label single-center, prospective, randomized, controlled phase 2 study. Patients undergoing PMP surgery with predicted intraoperative blood loss ≥2 L received human fibrinogen concentrate (HFC; 4 g) or cryoprecipitate (two pools of 5 units, containing approximately 4.0-4.6 g fibrinogen), repeated as needed. The primary endpoint was a composite of intraoperative and postoperative efficacy, graded using objective 4-point scales and adjudicated by an independent committee.ResultsOne hundred percent of patients receiving HFC (95% confidence interval: 83.9-100.0, n = 21) or cryoprecipitate (84.6-100.0, n = 22) achieved hemostatic success. HFC demonstrated noninferior efficacy (P = .0095; post hoc) and arrived in the operating room 46 minutes faster. There were significantly greater mean increases with HFC vs cryoprecipitate in plasma fibrinogen (0.78 vs 0.35 g/L; P < .0001) and FIBTEM A20 (3.33 vs 0.93 mm; P = .003). Factor XIII, factor VIII, and von Willebrand factor activity were maintained throughout surgery. Only red blood cells were transfused intraoperatively (median units: HFC group, 1.0; cryoprecipitate group, 0.5). Thromboembolic events were detected with cryoprecipitate only. Safety was otherwise comparable between groups.ConclusionsHuman fibrinogen concentrate was hemostatically efficacious in patients undergoing major abdominal PMP surgery, with a favorable safety profile. These results are relevant to other surgical settings where bleeding and acquired fibrinogen deficiency occur.
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