scholarly journals Polyglactin 910 versus irradiated polyglactin 910 for subcuticular closure in elective surgeries: a randomized double-blind study

2020 ◽  
Vol 8 (1) ◽  
pp. 242
Author(s):  
Darpan Bansal ◽  
Gurpreet Singh Bhangu ◽  
Shivkaran Kaur Gill ◽  
Divya Julka
Keyword(s):  
Tensile Strength ◽  
Suture Material ◽  
Wound Dehiscence ◽  
Double Blind Study ◽  
Skin Closure ◽  
Suture Materials ◽  
Polyglactin 910 ◽  
Chi Square ◽  
Double Blind

Background: All suture materials are treated as foreign bodies and bring out a reaction in the tissues. The severity and duration of response depends on the type of suture material used. The choice of suture material is based on the concept that it should provide adequate tensile strength across the wound until tissue tensile strength has adequately developed, approximation of the epithelial portion has occurred and that the suture material should be absorbed after serving its function. this study was done to compare irradiated polyglactin 910 (Vicryl Rapide) versus polyglactin 910 (Vicryl) for subcuticular skin closure in patients of elective surgeries and to note post-operative wound inflammation, pain, dehiscence and quality of scar.Methods: 60 consecutive patients undergoing elective surgeries in department of surgery SGRD hospital were taken up for the study from April 2020 to June 2020. After randomization the subjects were divided into two groups. Subcuticular skin closure at the end of surgery was done using a 3-0 polyglactin 910 in group A and 3-0 irradiated polyglactin 910 in group B with cutting needle in both groups. Postoperatively the wound was inspected on day 3, 5, 7 and again 3 weeks after surgery.Results:  Postoperatively the wounds were observed for the signs of inflammation and infection. Each was given a wound score according to scoring system. Statistical analysis by SPSS 17.0 software and chi-square test. Irradiated polyglactin 910 showed less inflammation, pain and dehiscence along with good quality of scar as compared to polyglactin 910 on comparison.Conclusions: It was concluded that irradiated polyglactin 910 was a better choice for suture material than polyglactin 910 for subcuticular skin closure in terms of postoperative pain, wound dehiscence and quality of scar.

Final results from ClarIDHy, a global, phase 3, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4069-4069
Author(s):  
Ghassan K. Abou-Alfa ◽  
Teresa Macarulla ◽  
Milind M. Javle ◽  
Robin Kate Kelley ◽  
Sam Joseph Lubner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Endpoint ◽  
Failure Time ◽  
Objective Response ◽  
Idh1 Mutation ◽  
High Rate ◽  
Double Blind Study ◽  
Double Blind ◽  
Grade 3

4069 Background: CCA is a rare cancer for which there are limited effective therapies. IDH1 mutations occur in ̃20% of intrahepatic CCAs, resulting in production of the oncometabolite D-2-hydroxyglutarate, which promotes oncogenesis. IVO (AG-120) is a first-in-class, oral, small-molecule inhibitor of mutant IDH1 (mIDH1). ClarIDHy aimed to demonstrate the efficacy of IVO vs PBO in pts with unresectable or metastatic m IDH1 CCA. The primary endpoint was met with significant improvement in progression-free survival (PFS) by independent radiology center (IRC) with IVO vs PBO (hazard ratio [HR] = 0.37, p < 0.0001). Objective response rate (ORR) and stable disease for IVO were 2.4% (3 partial responses) and 50.8% (n = 63) vs 0% and 27.9% (n = 17) for PBO. IVO pts experienced significantly less decline in physical and emotional functioning domains of quality of life at cycle 2 day 1 vs PBO pts (nominal p < 0.05). Methods: Pts with m IDH1 CCA were randomized 2:1 to IVO (500 mg PO QD) or matched PBO and stratified by prior systemic therapies (1 or 2). Key eligibility: unresectable or metastatic m IDH1 CCA based on central testing; ECOG PS 0–1; measurable disease (RECIST v1.1). Crossover from PBO to IVO was permitted at radiographic progression. Primary endpoint: PFS by IRC. Secondary endpoints included overall survival (OS; by intent-to-treat), ORR, PFS (by investigator), safety, and quality of life. The planned crossover-adjusted OS was derived using the rank-preserving structural failure time (RPSFT) model. Results: As of 31 May 2020, ̃780 pts were prescreened for an IDH1 mutation and 187 were randomized to IVO (n = 126) or PBO (n = 61); 13 remain on IVO. Median age 62 y; M/F 68/119; 91% intrahepatic CCA; 93% metastatic disease; 47% had 2 prior therapies. 70% of PBO pts crossed over to IVO. OS data were mature, with 79% OS events in IVO arm and 82% in PBO. Median OS (mOS) was 10.3 months for IVO and 7.5 months for PBO (HR = 0.79; 95% CI 0.56–1.12; one-sided p = 0.093). The RPSFT-adjusted mOS was 5.1 months for PBO (HR = 0.49; 95% CI 0.34–0.70; p < 0.0001). Common all-grade treatment emergent adverse events (TEAEs, ≥ 15%) in the IVO arm: nausea 41%, diarrhea 35%, fatigue 31%, cough 25%, abdominal pain 24%, decreased appetite 24%, ascites 23%, vomiting 23%, anemia 18%, and constipation 15%. Grade ≥ 3 TEAEs were reported in 50% of IVO pts vs 37% of PBO pts, with grade ≥ 3 treatment-related AEs in 7% of IVO pts vs 0% in PBO. 7% of IVO pts experienced an AE leading to treatment discontinuation vs 9% of PBO pts. There were no treatment-related deaths. Conclusions: IVO was well tolerated and resulted in a favorable OS trend vs PBO despite a high rate of crossover. These data – coupled with statistical improvement in PFS, supportive quality of life data, and favorable safety profile – demonstrate the clinical benefit of IVO in advanced m IDH1 CCA. Clinical trial information: NCT02989857.

A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naïve to potent opioids

2010 ◽  
Vol 1 (3) ◽  
pp. 122-141 ◽  
Author(s):  
Harald Breivik ◽  
Tone Marte Ljosaa ◽  
Kristian Stengaard-Pedersen ◽  
Jan Persson ◽  
Hannu Aro ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Relief ◽  
Low Dose ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Skin Reactions ◽  
Local Skin

AbstractObjectivePatients with osteoarthritis (OA) pain often have insufficient pain relief from non-opioid analgesics. The aim of this trial was to study efficacy and tolerability of a low dose 7-day buprenorphine transdermal delivery system, added to a NSAID or coxib regimen, in opioid-naïve patients with moderate to severe OA pain.MethodsA 6 months randomised, double-blind, parallel-group study at 19 centres in Denmark, Finland, Norway, and Sweden, in which OA patients (>40 years) with at least moderate radiographic OA changes and at least moderate pain in a hip and/or knee while on a NSAID or a coxib were randomised to a 7-day buprenorphine patch (n = 100) or an identical placebo patch (n = 99). The initial patch delivered buprenorphine 5 μg/h. This was titrated to 10 or 20 μg/h, as needed. Rescue analgesic was paracetamol 0.5–4 g daily. Statistical analysis of outcome data was mainly with a general linear model, with treatment as factor, the primary joint of osteoarthritis, baseline scores, and season as covariates.ResultsMost patients had OA-radiographic grade II (moderate) or grade III (severe), only 8 in each group had very severe OA (grade IV). The median buprenorphine dose was 10 μg/h. 31 buprenorphine-treated patients and 2 placebo-treated patients withdrew because of side effects. Lack of effect caused 12 placebo-treated and 7 buprenorphine-treated patients to withdraw. The differences in effects between treatments: Daytime pain on movement, recorded every evening on a 0–10 numeric rating scale decreased significantly more (P = 0.029) in the buprenorphine group. Patients’ Global Impression of Change at the end of the double blind period was significantly improved in the buprenorphine group (P = 0.017). The chosen primary effect outcome measure, the Western Ontario and McMaster Universities (WOMAC) OA Index for Pain (P = 0.061), and secondary outcome measures, the WOMAC OA score for functional abilities (P = 0.055), and the WOMAC total score (P = 0.059) indicated more effects from buprenorphine than placebo, but these differences were not statistically significant. In a post-hoc, subgroup analysis with the 16 patients with radiographic grad IV (very severe) excluded, WOMAC OA Index for Pain was significantly (P = 0.039) reduced by buprenorphine, compared with placebo. WOMAC OA score for stiffness and the amount of rescue medication taken did not differ. Sleep disturbance, quality of sleep, and quality of life improved in both groups. Side effects: Typical opioid side effects caused withdrawal at a median of 11 days before completing the 168 days double blind trial in 1/3 of the buprenorphine group. Mostly mild local skin reactions occurred equally often (1/3) in both groups.ConclusionsAlthough the 24 hours WOMAC OsteoArthritis Index of pain was not statistically significantly superior to placebo, day-time movement-related pain and patients’ global impression of improvement at the end of the 6-months double blind treatment period were significantly better in patients treated with buprenorphine compared with placebo. Opioid side effects caused 1/3 of the buprenorphine-patients to withdraw before the end of the 6-months double blind study period.ImplicationsA low dose 7-days buprenorphine patch at 5–20 μg/h is a possible means of pain relief in about 2/3 of elderly osteoarthritis patients, in whom pain is opioid-sensitive, surgery is not possible, NSAIDs and coxibs are not recommended, and paracetamol in tolerable doses is not effective enough. Vigilant focus on and management of opioid side effects are essential.

Daflon 500 mg: Symptoms and Edema

Angiology ◽  
2005 ◽  
Vol 56 (6_suppl) ◽  
pp. S25-S32 ◽  
Author(s):  
Albert-Adrien Ramelet
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Venous Disease ◽  
Double Blind Study ◽  
Life Questionnaire ◽  
Double Blind ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Significant Difference

Patients suffering from any class of the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) classification of chronic venous disease (CVD) may be symptomatic (C0s-C6s). Leg heaviness, discomfort, itching, cramps, pain, paresthesia, and edema (C3) are the most frequent manifestations of CVD and a major reason for medical consultation. Daflon 500 mg (micronized purified flavonoid fraction [MPFF]) is an effective treatment for symptoms and edema in CVD as demonstrated in several randomized controlled studies. A 2-month, double-blind study in 40 patients established the superiority of Daflon 500 mg over placebo with regard to symptoms and objective signs. This was confirmed in another double-blind, placebo-controlled trial (2 months’ treatment, 160 patients), and in the Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids (RELIEF) study. The latter included 5,052 patients in 23 countries, using a visual analog scale for evaluating pain, leg heaviness, cramps, and a sensation of swelling. All symptoms showed significant and progressive improvement. The quality-of-life results (scores on the ChronIc Venous Insufficiency quality of life Questionnaire [CIVIQ]) paralleled those of symptoms. The decrease in the ankle and calf circumferences was significantly greater (p<0.001) in the group of patients treated with Daflon 500 mg in two studies, and correlated well with the improvement in the sensation of swelling (p<0.001). This was confirmed with more sophisticated measurement techniques as in the RELIEF study or in a trial assessing edema with an optoelectronic volumeter in 20 patients. A further double-blind, randomized, controlled study established a statistically significant difference in favor of Daflon 500 mg in comparison with diosmin, both on symptoms and edema. The therapeutic efficacy of Daflon 500 mg on CVD symptoms and edema has been demonstrated in double-blind, randomized, controlled studies. Further studies using a new approach may define the most precise and validated methodology for application in future research in phlebology.

scholarly journals Epidural Pethidine or Fentanyl during Caesarean Section: A Double-Blind Comparison

1989 ◽  
Vol 17 (2) ◽  
pp. 157-165 ◽  
Author(s):  
M. J. Paech
Keyword(s):  
Side Effects ◽  
Caesarean Section ◽  
Epidural Fentanyl ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Single Bolus Dose ◽  
Clinical Advantage ◽  
Blind Comparison

The onset, quality and duration of analgesia and side-effects of a single bolus dose of either epidural pethidine 50 mg or fentanyl 100 mcg, administered immediately post-delivery, were compared in a randomised, double-blind study of fifty-five women undergoing epidural caesarean section. The onset of effect was more rapid with fentanyl, a significantly larger number of women achieving complete pain relief fifteen minutes post-administration (P<0.05). The quality of analgesia was good in both groups and the quality and duration of effective analgesia not significantly different. The incidence and severity of side-effects were low, with no significant difference between groups. One patient in the pethidine group experienced early onset respiratory depression; however, she did not require active treatment. Epidural fentanyl 100 mcg appears to offer a small clinical advantage over pethidine 50 mg for intraoperative use during caesarean section.

scholarly journals Self-perception of side effects by adolescents in a chlorhexidine-fluoride-based preventive oral health program

2006 ◽  
Vol 14 (4) ◽  
pp. 291-296 ◽  
Author(s):  
Ana Rita Duarte Guimaraes ◽  
Marco Aurélio Peres ◽  
Ricardo de Sousa Vieira ◽  
Rodrigo Melin Ferreira ◽  
Maria Letícia Ramos-Jorge ◽  
...  
Keyword(s):  
Oral Health ◽  
Side Effects ◽  
Adverse Effects ◽  
Health Program ◽  
Double Blind Study ◽  
Chi Square ◽  
Double Blind ◽  
Chi Square Test ◽  
Plaque Control ◽  
Descriptive Scale

OBJECTIVE: The objective of this study was to evaluate the incidence of adverse effects reported by adolescents following 14 days of use of a mouthrinse containing 0.05% NaF+0.12% chlorhexidine. METHODS: This double-blind study was developed as part of a randomized clinical trial. The adolescents enrolled to the study were randomly divided into two groups to use either: 0.05% NaF+0.12% chlorhexidine (G1, n=85) or 0.05% NaF (G2, n=85). Both groups used a 10mL solution of the mouthwash during 1 minute daily for 2 weeks under supervision. After that period, the subject's acceptance of taste was measured using a verbal descriptive scale (Labeled Magnitude Scale - LMS)11. Participants were also interviewed regarding the occurrence of possible adverse effects during treatment (temporary palate disorders, tooth staining or unpleasant taste). The proportional differences between the groups were tested using the chi-square test. RESULTS: Palate changes were reported by 26% of participants of each group; 17.7% of G1 and 32% of G2 reported an unpleasant taste (p = 0.062), while staining was reported by 55% of G1 and 68.9% of G2 (p = 0.117). Absenteeism rates were similar in both groups (G1= 2.58 ± 2.69; G2=2.81 ± 2.39), p=0.362. CONCLUSION: adherence was high in both groups and side effects reported by subjects were not perceived by them as being important. Since subjects' acceptance and compliance is fundamental to the success of an oral health program, chlorhexidine-fluoride could be a useful resource in a program of plaque control.

scholarly journals Comparative study of tissue response to polyglecaprone 25, polyglactin 910 and polytetrafluorethylene suture materials in rats

2002 ◽  
Vol 13 (2) ◽  
pp. 86-91 ◽  
Author(s):  
Hugo Nary Filho ◽  
Mariza Akemi Matsumoto ◽  
Aline Carvalho Batista ◽  
Luís César Lopes ◽  
Fernanda Costa Grizzo de Sampaio Góes ◽  
...  
Keyword(s):  
Suture Material ◽  
Oral Surgery ◽  
Subcutaneous Tissue ◽  
Tissue Response ◽  
Biological Behavior ◽  
Dorsal Region ◽  
Suture Materials ◽  
Polyglactin 910 ◽  
Hematoxylin And Eosin ◽  
Selection Of

The authors evaluated the biocompatibility of three suture materials, polyglecaprone 25, polyglactin 910 and polytetrafluorethylene, implanted into subcutaneous tissue in the dorsal region of 20 Wistar albinus rats. After periods of 2, 7, 14 and 21 days, the rats were sacrificed and the specimens were processed for routine histotechnical analysis and stained with hematoxylin and eosin. The rate of fibrosis, angioblastic and fibroblastic proliferation, and also the intensity of inflammation were observed with the optic microscope. The results showed that polyglecaprone 25 suture material induced a mild inflammatory reaction, followed by polyglactin 910 and polytetrafluorethylene, respectively. Such biological behavior must be considered during the selection of the suture material to be used in oral surgery.

A Rosa canina – Urtica dioica – Harpagophytum procumbens/zeyheri Combination Significantly Reduces Gonarthritis Symptoms in a Randomized, Placebo-Controlled Double-Blind Study

Planta Medica ◽  
2017 ◽  
Vol 83 (18) ◽  
pp. 1384-1391 ◽  
Author(s):  
Margret Moré ◽  
Joerg Gruenwald ◽  
Ute Pohl ◽  
Ralf Uebelhack
Keyword(s):  
Quality Of Life ◽  
Urtica Dioica ◽  
Womac Pain ◽  
Root Extract ◽  
Double Blind Study ◽  
Double Blind ◽  
Rosa Canina ◽  
Hplc Fingerprint ◽  
Harpagophytum Procumbens

AbstractThe special formulation MA212 (Rosaxan) is composed of rosehip (Rosa canina L.) puree/juice concentrate, nettle (Urtica dioica L.) leaf extract, and devilʼs claw (Harpagophytum procumbens DC. ex Meisn. or Harpagophytum zeyheri Decne.) root extract and also supplies vitamin D. It is a food for special medical purposes ([EU] No 609/2013) for the dietary management of pain in patients with gonarthritis.This 12-week randomized, placebo-controlled double-blind parallel-design study aimed to investigate the efficacy and safety of MA212 versus placebo in patients with gonarthritis.A 3D-HPLC-fingerprint (3-dimensional high pressure liquid chromatography fingerprint) of MA212 demonstrated the presence of its herbal ingredients. Ninety-two randomized patients consumed 40 mL of MA212 (n = 46) or placebo (n = 44) daily. The Western Ontario and McMaster Universities Arthritis Index (WOMAC), quality-of-life scores at 0, 6, and 12 weeks, and analgesic consumption were documented. Statistically, the initial WOMAC subscores/scores did not differ between groups. During the study, their means significantly improved in both groups. The mean pre-post change of the WOMAC pain score (primary endpoint) was 29.87 in the MA212 group and 10.23 in the placebo group. The group difference demonstrated a significant superiority in favor of MA212 (pU < 0.001; pt < 0.001). Group comparisons of all WOMAC subscores/scores at 6 and 12 weeks reached same significances. Compared to placebo, both physical and mental quality of life significantly improved with MA212. There was a trend towards reduced analgesics consumption with MA212, compared to placebo. In the final efficacy evaluation, physicians (pChi < 0.001) and patients (pChi < 0.001) rated MA212 superior to placebo. MA212 was well tolerated.This study demonstrates excellent efficacy for MA212 in gonarthritis patients.

The effect of lavandula angustifolia in the treatment of depression

2011 ◽  
Vol 26 (S2) ◽  
pp. 624-624 ◽  
Author(s):  
N. Parvin ◽  
S. Farzaneh ◽  
M. Nikfarjam ◽  
N. Shahinfard ◽  
N. Asarzadegan
Keyword(s):  
Depression Score ◽  
Control Group ◽  
Case Group ◽  
Double Blind Study ◽  
Control Groups ◽  
Chi Square ◽  
Double Blind ◽  
Treatment Of Depression ◽  
Severity Of Depression ◽  
And Control

Background and aimMedical plants have been used for centuries as a medicinal agent in treatment of depression and anxiety. The purpose of this study was to explore the effects of the lavendula officinalis on depression in patients using citalopram.MethodsThis clinical trial study was performed in Hajar hospital, Shahrekord, Iran. In this study eighty patients randomly allocated into two groups (40 patients in each group). Patients who complained from depression were studied during a two-month double-blind study. In control group, patients were given 20 mg citalopram twice daily plus placebo and case group were treated with 5 g arial part of dried Lavendula officinalis and citaloperam (20 mg, twice per day). After 4 and 8 weeks, patients were followed for evaluations of their depression and complications. Depression severity was scored using standard Hamilton’s depression questionnaire. Data were analyzed using Chi square and Paired-t test.ResultsAfter 1 month treatment, mean depression score in case and control groups were 15.2 ± 3.6 and 17.5 ± 3.5, respectively (P < 0.05). After 2 months the mean score of depression in case and control groups was 14.8 ± 4 and 16.8 ± 4.6, respectively (P < 0.01). The most common side effects in two groups were confusion and dry mouth, which were not significantly different between two groups.ConclusionLavendula officinalis has a positive effect on depressed patients and may be useful to decrease the severity of depression in patients using other antidepressants.

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