Prevention of nasal septoplasty surgical site infections by povidine-iod disinfection: proposal for a pragmatic randomized controlled study (Preprint)

2021 ◽  
Author(s):  
Jan Mikael Gerl ◽  
Truls Leegaard ◽  
Rohit Singh ◽  
Preben Homøe ◽  
Gregor Bachmann-Harildstad
Keyword(s):  
Controlled Trial ◽  
Surgical Site Infections ◽  
Standard Of Care ◽  
Controlled Study ◽  
Nasal Surgery ◽  
Randomized Controlled ◽  
Long Run ◽  
Hand Wash ◽  
Life Threatening ◽  
Clean Contaminated

UNSTRUCTURED Surgical site infections (SSIs) from nasal bacteria are an increasingly feared complication in general surgery, in implantation surgery and in intensive care units with consequences for the patient and society not only in the short, but also in the long run. The increasing hazard of antibiotic resistances may accelerate this problem. In rhinosurgery, SSIs as a complication consist of either local wound infections, septal perforation, pneumonia or life-threatening sepsis. Standard of care for rhinosurgery is surgical hand wash, sterile drapes, gloves and antiseptic disinfection of the skin around the mid-face. Surgeons perform septoplasties in a clean contaminated field and the disinfection of the surgical field in the nasal vestibule and nasal cavity at nasal surgery is not common practice. The infection rates for septorhinoplasty spread along the range of 1 to 27 % according to the literature. It is therefore unknown, whether endonasal disinfection at nasal surgery will prevent the rate of postoperative SSIs. For the proposed pragmatic randomized controlled trial (pRCT), we chose the following primary goal: The preventive effect of aqueous povidine-iod (PVP-I) disinfection on septoplasty related SSIs. As secondary goals serve (a) to determine the safety of endonasal disinfection using PVP-I, (b) to identify the risk of endonasal PVP-I toxicity on olfactory epithelium, (c) to characterize the endonasal microbiota dependent on endonasal PVP-I disinfection in the short- and the long-term and d) to identify the endonasal microbiota in septoplasty related SSI and in septoplasty related uneventful follow-up.

scholarly journals Clinical Results of the NUsurface® Meniscus Implant versus Non-Surgical Controls at 24 months: Data from a Pooled cohort of a randomized controlled study and single arm study

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0036
Author(s):  
R Alley ◽  
Richard Alfred ◽  
Richard Edelson ◽  
Jonathan Greenleaf ◽  
Wayne Gersoff ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Clinical Results ◽  
Long Term Results ◽  
Controlled Study ◽  
Control Group ◽  
Event Analysis ◽  
Reconstructive Procedures ◽  
Randomized Controlled ◽  
Early Results

Objectives: To demonstrate comparative KOOS outcomes (Symptoms, Pain, ADL, Sports/Rec, QoL, and Overall) of a synthetic meniscus implant versus non-surgical controls in treatment of persistent post meniscectomy knee pain. Methods: 242 patients enrolled in a pooled population, randomized controlled trial (RCT) and single-arm study, comparing the investigational device to non-surgical standard of care. Of the first 100 patients enrolled, whose follow-up has exceeded 24 months, 65 patients were treated with the meniscus implant, and 35 were treated non-surgically (Table 1). Validated KOOS scores at baseline, 6-week, 6-month, 12-month, and 24-month time points were obtained from all patients where a “clinically significant improvement” was considered to be an increase of 20 KOOS points, based on Roos et al., (2003). The investigational and control cohorts were compared at each time point using a two tailed t-test. All baseline cohort comparisons of demographics and KOOS scores were not statistically different (p>0.05). Results: Improvement in KOOS Pain for the investigational vs control cohorts at 6-months was 25.0 vs 10.5 points at 6-months, 31.1 vs 14.5 points at 12-months, and 29.5 vs 13.6 points at 24-months, respectively (Figure 1). Similarly, improvement in KOOS Overall for investigational vs controls was 23.3 vs 8.0 points at 6-months, 29.2 vs 11.4 points at 12-months, and 29.1 vs 13.4 points at 24-months, respectively. These data show a statistically significant improvement, above the clinically meaningful threshold, in the investigational arm versus the control arm as early as 6 months (p<0.001) and continues through the 12-month timepoint (p<0.001) and the 24-month timepoint (p<0.001). At 24 months, 5 (7.7%) investigational vs. 5 (14.3%) control patients were no longer qualified to remain in the study, and deemed study failures, due to removal of the investigational device, and due to non-surgical control patients receiving surgical intervention (Table 1). Adverse event analysis showed that at 12 months, more patients progressed to advanced knee reconstructive procedures in the non-surgical, control group (n=4, 11.4%) than in the surgical, investigational group (n=2, 3.1%). Conclusion: Early results of effectiveness using KOOS subscales and KOOS overall are encouraging. The investigational treatment showed statistically different outcomes, above the clinically important threshold, at 6, 12 and 24 months compared to non-surgical controls. The clinical study is ongoing, with long-term results to be reported in the future. [Table: see text][Figure: see text]

scholarly journals Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled Study

2021 ◽  
Author(s):  
Nien Xiang Tou ◽  
Shiou-Liang Wee ◽  
Wei Ting Seah ◽  
Daniella Hui Min Ng ◽  
Benedict Wei Jun Pang ◽  
...  
Keyword(s):  
Older Adults ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Controlled Study ◽  
Power Training ◽  
Frail Older Adults ◽  
Frailty Status ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

AbstractTranslation of community-based functional training for older adults to reduce frailty is still lacking. We evaluated the effectiveness and implementation of a community-delivered group-based functional power training (FPT) program for frail older adults within their neighborhoods. A two-arm, multicenter assessor-blind stratified randomized controlled trial was conducted at four local senior activity centers in Singapore. Sixty-one community-dwelling older adults with low handgrip strength were randomized to intervention (IG) or control (CG) group. The IG underwent the FPT program (power and balance exercises using simple equipment) delivered by a community service provider. The 12-week program comprised 2 × 60 min sessions/week. CG continued usual activities at the centers. Functional performance, muscle strength, and frailty status were assessed at baseline and 3 months. Program implementation was evaluated using RE-AIM framework. The program was halted due to Coronavirus Disease 2019-related suspension of senior center activities. Results are reported from four centers, which completed the program. IG showed significantly greater improvement in the Short Physical Performance Battery test as compared to CG (p = 0.047). No effects were found for timed up and go test performance, muscle strength, and frailty status. The community program exhibited good reach, effectiveness, adoption, and implementation. Our study demonstrated that FPT was associated with greater improvement in physical function in pre-frail/frail participants as compared to exercise activities offered at local senior activity centers. It is a feasible intervention that can be successfully implemented for frail older adults in their neighborhoods. Trial registration ClinicalTrials.gov, NCT04438876. Registered 19 June 2020–retrospectively registered.

scholarly journals Current FDA-Approved Therapies for High-Grade Malignant Gliomas

Biomedicines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 324
Author(s):  
Jacob P. Fisher ◽  
David C. Adamson
Keyword(s):  
Controlled Trial ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
High Grade ◽  
Tumor Treatment ◽  
Free Survival ◽  
Randomized Controlled ◽  
Significant Survival ◽  
One Year

The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months. Before this SOC was established, glioblastoma (GBM) patients typically lived for less than one year after diagnosis, and no adjuvant chemotherapy had demonstrated significant survival benefits compared with radiation alone. In 2005, the Stupp et al. randomized controlled trial (RCT) on newly diagnosed GBM patients concluded that RT plus TMZ compared to RT alone significantly improved overall survival (OS) (14.6 vs. 12.1 months) and progression-free survival (PFS) at 6 months (PFS6) (53.9% vs. 36.4%). Outside of TMZ, there are four drugs and one device FDA-approved for the treatment of HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ), and tumor treatment fields (TTFields). These treatments are now mainly used to treat recurrent HGGs and symptoms. TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC. TTFields is the newest addition to this list of FDA-approved treatments, but has not been universally accepted yet as part of SOC.

scholarly journals Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aaron Gazendam ◽  
◽  
Seper Ekhtiari ◽  
Nolan S. Horner ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Control ◽  
Shoulder Arthroscopy ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Standard Of Care ◽  
Opioid Prescription ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

scholarly journals Transconjunctival versus Transcutaneous Injection of Botulinum Toxin into the Lacrimal Gland to Reduce Lacrimal Production: A Randomized Controlled Trial

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 77
Author(s):  
Andrew G. Lee ◽  
Shin-Hyo Lee ◽  
Minsu Jang ◽  
Sang Jae Lee ◽  
Hyun Jin Shin
Keyword(s):  
Botulinum Toxin ◽  
Lacrimal Gland ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Delivery Routes ◽  
Tear Meniscus Height

The purpose of this study was to determine and compare the effects between injecting botulinum toxin A (BTX-A) transconjunctivally into the palpebral lobe and transcutaneously into the orbital lobe of the lacrimal gland in patients with epiphora due to lacrimal outflow obstruction. This randomized controlled study included 53 eyes of 31 patients with unilateral or bilateral epiphora. Patients were randomly allocated to receive an injection of BTX-A (3 units) either transconjunctivally (n = 15, 25 eyes) or transcutaneously (n = 16, 28 eyes). For objective assessments, the tear meniscus height and Schirmer’s I test with topical anesthesia were measured at baseline and after 2, 6, 12, and 24 weeks of follow-up. Subjective evaluations were performed using the Munk score. After BTX-A injection, patients in both groups experienced significant objective and subjective reductions in tearing at all follow-up times compared to pre-injection (success rate 86.8%), and the effect lasted for a mean duration of 5.63 months. The two delivery routes showed similar clinical effectiveness for a single injected dose of BTX-A. In conclusion, injecting BTX-A via either a transconjunctival or transcutaneous route helps to reduce normal tear production and results in significant improvements in the symptoms in patients with epiphora.

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