Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.
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ABSTRACT:
SUBMITTER: Hesselvig AB
PROVIDER: S-EPMC7170680 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The purpose of this study is to assess the efficacy and safety of intracameral mydriatic solution, as compared to preoperative topical mydriatics, in patients undergoing manual small incision cataract surgery (MSICS) under peribulbar anesthesia. To assess the sustainability of intracameral mydriasis in MSICS by monitoring pupil size at specific junctures during the surgery.This trial recruited 127 patients, who underwent MSICS under peribulbar block. Mydriasis in topical group was achieved with preoperative topical dilating drops while patients in intracameral group were taken up for surgery without dilation, and mydriasis was achieved intraoperatively with intracameral solution. Pupil sizes were measured serially, at six different junctures during surgery. Time duration of surgery, any intraoperative complications and first postoperative day visual acuity, corneal edema score, and anterior chamber inflammation score were noted in all patients.Mean pupil size just before peribulbar block was 7.3 mm in topical group and 3.3 mm in intracameral group (P < 0.001). Mean pupil size in intracameral group increased to 7.3 mm 30 s after injecting intracameral dilating solution. Mean pupil size in both groups progressively reduced, reaching 5.5 mm (topical group) and 6.2 mm (intracameral group) just before intraocular lens implantation (P = 0.001), and measured 5.1 mm and 5.5 mm, respectively, at the end of surgery (P = 0.048). On first postoperative day, there was no significant difference in distribution of corneal edema scores, AC inflammation scores, and in median logMAR visual acuity between the two groups.MSICS can be performed effectively and safely utilizing intracameral mydriatic solution, without the use of preoperative dilating drops.CTRI/2016/06/007036.
| S-EPMC5549410 | biostudies-other
Project description:Comparison between pretreated donor grafts corticosteroid vs. placebo Prospective, randomised, double-blind, placebo-control trial, xls files contain normalized data (Default Total Intensity Normalization, see Stanford Microarray Database website), gpr files the raw data
2010-08-17 | E-GEOD-14700 | biostudies-arrayexpress
Project description:Comparison between pretreated donor grafts corticosteroid vs. placebo
2010-08-17 | GSE14700 | GEO
Project description:BackgroundScar visibility is multifactorial and skin closure technique is thought to play an important role. It is an established principle in plastic surgery that Z plasties generally reduce scar contracture by breaking up the lines of tension in a wound. As an extension of this principle, it is postulated that irregular "deckled" skin incisions made during tumor excision would produce aesthetically superior scars.ObjectiveThe primary objective of this study is to assess both the clinician and patient opinion of scar quality using the Patient and Observer Scar Assessment Scale (POSAS). Secondary objectives include the proportion of scars judged as good by the both the patient and clinician (less than or equal to 5 on the overall PSOAS scale), the number of adverse events, and the proportion of the scar visible at 1 meter.MethodsThe deckling study will be a patient-blinded, simple randomized controlled trial (RCT) at a single center institution. The two groups will be equally allocated on a 1:1 ratio into the control and treatment arms. All patients greater than 18 years of age undergoing a plastic surgery procedure involving excision of skin lesions will be enrolled. Any patients requiring re-excision through the wound or undergoing injectable corticosteroid therapy will be excluded. A total of 500 patients will be enrolled. The patients will be followed-up at 1 week, 3 months, and 6 months post-operatively.ResultsThe study is expected to begin enrolment in August 2016. We anticipate that the deckling study group will have superior scar outcomes when compared to the straight line incision. From clinical experience this is especially true for lesions involving the face and in those areas of the skin that have undergone radiation therapy. The study will be funded by the Plastics and Reconstructive Surgery Department at St Vincent's Hospital, Sydney, Australia. Ethics approval has been obtained for the study.ConclusionWe believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort.ConclusionsWe believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000193471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000193471 (Archived by Webcite at http://www.webcitation.org/6gmG8yf1A).
| S-EPMC4961880 | biostudies-literature
Project description:BackgroundPostoperative surgical site infection (SSI) is one of the most common hospital infections and contributes substantially to postoperative morbidity and mortality. In addition, SSIs dramatically increase the treatment cost and length of hospital stay. Following visceral surgery by laparotomy, SSI rates are especially high (14-25%). Therefore, measures to prevent SSI in this field are urgently needed. Prophylactic intraoperative wound irrigation (IOWI) of the subcutaneous soft tissue before skin closure hypothetically represents an easy and economical option to reduce SSI rates and is already frequently used in clinical practice. However, there are currently no definite recommendations on the use of IOWI since high-level evidence supporting its use is lacking. Consequently, clinical practice varies widely. Antiseptic polyhexanide (PHX)-based solutions are approved for soft-tissue wound irrigation in surgery but have not been specifically evaluated in randomized clinical trials for the prevention of SSI following laparotomy for visceral surgery.Methods/designThe IOWISI trial is a multicentre, randomized, observer- and patient-blinded clinical trial with three parallel treatment groups, comparing IOWI with a 0.04% PHX solution to no irrigation (test 1) or saline (test 2) before skin closure after laparotomy for visceral surgery (contamination level II-IV). The primary endpoint of the trial is the SSI rate within 30 days postoperatively. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 2.5% for test 1 and 5% for test 2 and the sample size (n = 540) is determined to assure a power of 94% (test 1) and 85% (test 2).DiscussionThe IOWISI trial will provide high-level evidence as a basis for clinical recommendations regarding the use of IOWI with PHX or saline and will potentially impact on future clinical guidelines and practice. The pragmatic trial design guarantees high external validity.Trial registrationRegistered at the German Clinical Trials Register, DRKS00012251 . Registered on 3 July 2017.
| S-EPMC5584516 | biostudies-literature
Project description:Background ?Postcesarean wound morbidity is a costly complication of cesarean delivery for which preventative strategies remain understudied. Objective ?We compared surgical site occurrences (SSOs) in cesarean patients receiving closed-incision negative-pressure therapy (ciNPT) or standard-of-care (SOC) dressing. Study Design ?A single-center randomized controlled trial compared ciNPT (5-7 days) to SOC dressing (1-2 days) in obese women (body mass index [BMI]???35), undergoing cesarean delivery between 2012 and 2014. Participants were randomized 1:1 and monitored 42?±?10 days postoperatively. The primary outcome SSOs included unanticipated local inflammation, wound infection, seroma, hematoma, dehiscence, and need for surgical or antibiotic intervention. Results ?Of the 92 randomized patients, 82 completed the study. ciNPT and SOC groups had similar baseline characteristics. Mean BMI was 46.5?±?6.5 and no treatment-related serious adverse events. Compared with SOC, the ciNPT group had fewer SSOs (7/43 [16.3%] vs. 2/39 [5.1%], respectively; p? =?0.16); significantly fewer participants with less incisional pain both at rest (39/46 [84.8%] vs. 20/46 [43.5%]; p ?<?0.001) and with incisional pressure (42/46 [91.3%] vs. 25/46 [54.3%]; p? <?0.001); and a 30% decrease in total opioid use (79.1 vs. 55.9?mg morphine equivalents, p? =?0.036). Conclusion ?A trend in SSO reduction and a statistically significant reduction in postoperative pain and narcotic use was observed in women using ciNPT.
| S-EPMC5511052 | biostudies-literature
Project description:BackgroundObesity disproportionately affects Latino youth. Community clinics are an important resource, yet there is little evidence for the efficacy of clinic-based approaches in this population.ObjectiveThe purpose of this study was to test the efficacy of a clinic-based intervention to lower body mass index (BMI) and improve body composition among overweight Latino children.MethodsA randomized trial (2 group × 3 repeated measures) was conducted among 297 randomly sampled, overweight paediatric patients (5-10 years old) and their parents. The 12-month family-based culturally tailored behavioural intervention (Luces de Cambio) was based on the 'traffic light' concepts to address behaviour change and was delivered by clinic health educators and mid-level providers. The primary study outcome was child BMI (kg m-2 ) assessed at baseline, 6-month (n = 191) and 12-month (n = 201) post-baseline. A subsample of the children was examined for overall and site-specific adiposity using dual-energy X-ray absorptiometry (n = 79).ResultsThere were no significant intervention effects on child BMI (p > 0.05); however, intervention children showed significantly (p < 0.05) lower total and trunk per cent fat compared with the usual care condition.ConclusionsThe Luces intervention did not reduce child BMI, yet small but significant reductions were observed for child per cent body fat. Further research is needed to identify and reduce barriers to recruitment and participation among Latino families.
| S-EPMC6420225 | biostudies-literature
Project description:Urinary, sexual and anorectal sequelae are frequent after rectal cancer surgery and were found to be related to intraoperative neurogenic impairment. Neuromonitoring methods have been developed to identify and preserve the complex pelvic autonomic nervous system in order to maintain patients' quality of life. So far no randomized study has been published dealing with the role of neuromonitoring in rectal cancer surgery.NEUROS is a prospective two-arm randomized controlled multicenter clinical trial comparing the functional outcome in rectal cancer patients undergoing total mesorectal excision (TME) with and without pelvic intraoperative neuromonitoring (pIONM). A total of 188 patients will be included. Primary endpoint is the urinary function measured by the International Prostate Symptom Score. Secondary endpoints consist of sexual, anorectal functional outcome and safety, especially oncologic safety and quality of TME. Sexual function is assessed in females with the Female Sexual Function Index and in males with the International Index of Erectile Function. For evaluation of anorectal function the Wexner-Vaizey score is used. Functional evaluation is scheduled before radiochemotherapy (if applicable), preoperatively (baseline), before hospital discharge, 3 and 6 months after stoma closure and 12 months after surgery. For assessment of safety adverse events, the rates of positive resection margins and quality of mesorectum are documented.This study will provide high quality evidence on the efficacy of pIONM aiming for improvement of functional outcome in rectal cancer patients undergoing TME.Clinicaltrials.gov: NCT01585727 . Registration date is 04/25/2012.
| S-EPMC4875600 | biostudies-literature
Project description:Aims/hypothesis: Dietary restriction (DR) reduces adiposity and improves metabolism in patients with one or more symptoms of the metabolic syndrome. Nonetheless, it remains elusive whether the benefits of DR in humans are mediated by calorie or nutrient restriction. This study was conducted to identify whether isocaloric dietary protein restriction is sufficient to confer the beneficial effects of dietary restriction in patients with metabolic syndrome. Methods: We performed a prospective, randomized controlled dietary intervention under constant nutritional and medical supervision. A total of 21 individuals diagnosed with the metabolic syndrome was randomly assigned for caloric restriction (CR; n = 11, mean age 49 ± 8.5 years, female 63%; diet of 5,941 ± 686 KJ per day) or isocaloric dietary protein restriction (PR; n = 10, mean age 51.6 ± 8.9 years, female 50%; diet of 8,409 ± 2,360 KJ per day) and followed for 27 days. Results: Like CR, PR promoted weight loss (-6.6%, P= 0.0041) due to reduction in adiposity (-9.9%, P= 0.0007), associated with reductions in blood glucose (-52.7%, P= 0.0002), lipid levels (cholesterol, -35.4%, P= 0.0010; triglycerides, -39.5% P= 0.0022) and blood pressure (systolic, -37.7 P< 0.0001; diastolic, -73.2% P< 0.0001). PR resulted in enrichment of metabolic pathways related to the immune system such as B cell proliferation, lymphocyte proliferation and leukocyte proliferation in subcutaneous adipose tissue. Hence, a reduction in calorie intake or changes in the gut microbiome are not necessary to confer the metabolic benefits of DR. Instead, a reduction in protein intake with a mild increase in carbohydrate intake to maintain the isocaloric balance of the diet is sufficient to improve metabolic control. Conclusions/interpretation: Protein restriction is sufficient to confer almost the same clinical outcomes as calorie restriction without the need for a reduction in calorie intake. The isocaloric characteristic of the PR intervention makes this approach a more attractive and less drastic dietary strategy in clinical settings and has greater potential to be used as adjuvant therapy for people with the metabolic syndrome.
2022-06-20 | GSE192587 | GEO
Project description:Background and purpose - Iodine-impregnated incision drapes (IIIDs) are used to prevent surgical site infection (SSI). However, there is some evidence to suggest a potential increase in SSI risk as a result of IIID use, possibly from promotion of skin recolonization. A greater number of viable bacteria in the surgical field of an arthroplasty, and surgery in general, may increase the infection risk. We investigated whether IIID use increases bacterial recolonization compared to no drape use under conditions of simulated total knee arthroplasty (TKA). Methods - 20 patients scheduled for TKA were recruited. Each patient had 1 knee randomized for draping with IIID, while the contralateral knee was left bare. The patients thus served as their own control. The operating room conditions and perioperative procedures of a TKA were simulated. Cylinder samples were collected from the skin of each knee prior to disinfection, and again on 2 occasions after skin preparation-75 min apart. Quantities of bacteria were estimated using a spread plate technique under aerobic conditions. Results - We found similar quantities of bacteria on the intervention and control knees immediately after skin disinfection and after 75 min of simulated surgery. These quantities had not increased at the end of surgery when compared to baseline, so no recolonization was detected on the draped knees or on the bare knees. Interpretation - The use of IIIDs did not increase bacterial recolonization in simulated TKA. This study does not support the hypothesis that IIIDs promote bacterial recolonization and postoperative infection risk.
| S-EPMC4967281 | biostudies-literature