Multizentrische randomisierte und kontrollierte Studie zum Vergleich von Four layer Bandagen und Kurzzugbinden des venösen Ulkus

VASA ◽  
2001 ◽  
Vol 30 (2) ◽  
pp. 108-113 ◽  
Author(s):  
H. Partsch ◽  
R.J. Damstra ◽  
D.J. Tazelaar ◽  
S. Schuller-Petrovic ◽  
A.J. Velders ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Local Therapy ◽  
Healing Time ◽  
Complete Healing ◽  
Venous Ulcers ◽  
Kaplan Meier ◽  
Initial Area ◽  
Dutch Study ◽  
Ulcer Healing Rate ◽  
Randomised Controlled

Background: Aim of the study was to compare the healing rates of venous ulcers obtained with four-layer bandages (4LB) versus short stretch bandages (SSB). Design: Multicentre, randomised controlled trial performed in 5 centres of the Netherlands and in 2 centres in Austria ("PADS-study" = Profore™ Austrian Dutch Study). Patients and methods: 112 patients (53 treated with 4LB and 59 treated with SSB) completed at least one post-treatment follow-up, 90 completed the study. Bandaging and ulcer assessment was performed at weekly intervals. Randomisation was carried out for each centre and was stratified according to the size (more or less than 10 cm2) of the ulcerated area. Local therapy consisted of plain absorbing, non-adherent dressings. Time to complete healing was recorded up to a maximum of 16 weeks. The two treatment-groups were comparable regarding their baseline-characteristics. Results: In total 33/53 (62%) of ulcer-patients were healed in the 4LB group, compared with 43/59 (73%) in the SSB group (difference 11%, 95% CI –28% to 7%). 77% of the ulcers with an initial area less than 5cm2 healed as compared with 33% of the larger ulcers. The different healing rates in the centres could be explained by the different sizes of the treated ulcers. Based on Kaplan-Meier estimates the median healing time was 57 days for the 4LB (95% CI 47–85 days) and 63 days for the SSB (95% CI 43–70 days). Conclusion: The ulcer healing rate and the median healing time did not differ among the two types of bandages. The main discriminant criterion for healing was the initial ulcer size. In centres who are experienced users of short-stretch bandages, no statistically significant different healing rates of venous ulcers could be found after 4LB or SSB.

scholarly journals Protocol for a randomised controlled trial of 90% kanuka honey versus 5% aciclovir for the treatment of herpes simplex labialis in the community setting

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017766 ◽  
Author(s):  
Alex Semprini ◽  
Joseph Singer ◽  
Nicholas Shortt ◽  
Irene Braithwaite ◽  
Richard Beasley
Keyword(s):  
New Zealand ◽  
Herpes Simplex ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Healing Time ◽  
Research Network ◽  
Cold Sore ◽  
Cold Sores ◽  
Randomised Controlled ◽  
Medical Grade

IntroductionWorldwide, about 90% of people are infected with the herpes simplex virus, 30% of whom will experience recurrent herpes simplex labialis, commonly referred to as ‘cold sores’, which can last up to 10 days. The most common treatment is aciclovir cream which reduces healing time by just half a day compared with no specific treatment. This is a protocol for a randomised controlled trial (RCT) to determine the efficacy of medical grade kanuka honey-based topical treatment (Honevo) in reducing the healing time and pain of cold sores, compared with topical aciclovir treatment (Viraban).Methods and analysisThis open-label, parallel-group, active comparator superiority RCT will compare the efficacy of medical grade kanuka honey with 5% aciclovir cream in the treatment of cold sores in the setting of a pharmacy research network of 60 sites throughout New Zealand. Adults presenting with a cold sore (N=950) will be randomised by pharmacy-based investigators. The pharmacy-based investigators will dispense the investigational product to randomised participants and both study groups apply the treatment five times daily until their skin returns to normal or for 14 days, whichever occurs first. In response to a daily SMS message, participants complete an assessment of their cold sore healing, with reference to a visual guide, and transmit it to the investigators by a smartphone eDiary in real time. The primary outcome variable is time (in days) from randomisation to return to normal skin. Secondary endpoints include total healing time stratified by stage of the lesion at onset of treatment, highest pain severity and time to pain resolution.Ethics and disseminationNew Zealand Ethics Registration 15/NTB/93. Results will be published in a peer-reviewed medical journal, presented at academic meetings and reported to participants.Trial registration numberAustralia New Zealand Clinical Trials Registry: ACTRN12615000648527, pre-results.SCOTT Registration: 15/SCOTT/14Protocol version4.0 (12 June 2017)

scholarly journals Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Helen Tilbrook ◽  
Rachael O. Forsythe ◽  
Debbie Rolfe ◽  
Laura Clark ◽  
Martin Bland ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Venous Ulcers ◽  
Randomised Controlled

Evaluation of the Jobst UlcerCare System for the Treatment of Venous Ulcers

1998 ◽  
Vol 13 (4) ◽  
pp. 163-165 ◽  
Author(s):  
U. Baccaglini ◽  
E. Giraldi ◽  
G. Spreafico ◽  
P. Sorrentino ◽  
C. Castoro ◽  
...  
Keyword(s):  
Venous Ulcer ◽  
Healing Time ◽  
Complete Healing ◽  
Compression Stocking ◽  
Venous Ulcers ◽  
Ambulatory Patients ◽  
Elastic Stockings ◽  
University Of Padua ◽  
The University ◽  
Care System

Objective: To test the Jobst ulcer care system (JUCS), a combination of two elastic stockings and a dressing, for the treatment of venous ulcers. Design: Cohort study. Setting: Therapy was performed at home by the patient with weekly visits to the outpatient clinic at the teaching hospital of the University of Padua. Patients: Thirty-one consecutive ambulatory patients with confirmed venous ulcer. Treatment: Patients were instructed to wear the low-compression stocking (liner) day and night and the higher compression stocking (therapeutic stocking with zipper) during the day. The wound dressing (Cutinova foam) was changed as judged by the patient. Main outcome measures: Healing of the ulcer, and tolerance, safety and ease of using the JUCS by the patient. Results: Twenty-four patients completed the study; 23 Patients showed complete healing of the ulcer within 16 weeks and in the 24th patient the healing was completed in 18 weeks. The mean healing time was 5.8 weeks. Conclusions: The Jobst ulcer care system is effective in achieving ulcer healing and the elastic stockings showed no significant side-effects and were easy to use.

scholarly journals Onset of analgesia by a topically administered flurbiprofen lozenge: a randomised controlled trial using the double stopwatch method

2018 ◽  
Vol 12 (4) ◽  
pp. 208-216 ◽  
Author(s):  
Bernard Schachtel ◽  
Sue Aspley ◽  
Adrian Shephard ◽  
Emily Schachtel ◽  
Mary Beth Lorton ◽  
...  
Keyword(s):  
Pain Relief ◽  
Sore Throat ◽  
Median Time ◽  
Controlled Trial ◽  
Moderate Intensity ◽  
Onset Of Action ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Kaplan Meier ◽  
Randomised Controlled

Background: The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs. Objective: The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge. Methods: Adults with acute sore throat (n = 122) were examined to confirm the presence of tonsillopharyngitis (Tonsillo-Pharyngitis Assessment) and sore throat pain of at least moderate intensity (≥6 on a 0–10 Sore Throat Scale). Lozenges containing flurbiprofen 8.75 mg or inert ingredients (identically flavoured) were administered under double-blind conditions in the clinic while patients assessed pain and pain relief over 3 hours. Onset of analgesia was determined using the DSW method and reported as the Kaplan–Meier median time to meaningful relief. The median time to first perceived relief was also documented. Results: About 78% of flurbiprofen-treated patients reported meaningful pain relief compared with 48% of placebo-treated patients (p < 0.01); median time to meaningful relief for flurbiprofen-treated patients was 43 minutes (placebo-treated patients were right-censored due to non-responsivity; p = 0.01). Median time to first perceived pain relief was 11 minutes for flurbiprofen-treated patients and 19 minutes for placebo-treated patients (p = 0.03). Flurbiprofen lozenge was well tolerated, with no serious adverse events occurring and no patient discontinuing due to an adverse event. Conclusion: These results indicate that the DSW method can be successfully applied to the evaluation of the onset of action of a locally administered analgesic in patients with acute sore throat, demonstrating that the onset of action (time to meaningful pain relief) of flurbiprofen lozenge was <45 minutes.

scholarly journals Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial

2017 ◽  
Vol 51 (6) ◽  
pp. 605-614 ◽  
Author(s):  
Ruth M. Santamaría ◽  
N.P.T. Innes ◽  
Vita Machiulskiene ◽  
Julian Schmoeckel ◽  
Mohammad Alkilzy ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Survival Rates ◽  
Randomised Clinical Trial ◽  
Primary Molars ◽  
Management Options ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Caries Management ◽  
Caries Removal ◽  
Randomised Controlled

Less invasive caries management techniques for treating cavitated carious primary teeth, which involve the concept of caries control by managing the activity of the biofilm, are becoming common. This study aimed to compare the clinical efficacy (minor/major failures) and survival rates (successful cases without any failures) of 3 carious lesion treatment approaches, the Hall Technique (HT), non-restorative caries treatment (NRCT), and conventional restorations (CR), for the management of occlusoproximal caries lesions (ICDAS 3-5) in primary molars. Results at 2.5 years are presented. A total of 169 children (3- to 8-year-olds) were enrolled in this secondary care-based, 3-arm parallel-group, randomised controlled trial. Participants were allocated to: HT (n = 52; sealing caries with stainless-steel crowns without caries removal), NRCT (n = 52; opening up the cavity and applying fluoride varnish), CR (n = 65; control arm, complete caries removal and compomer restoration). Statistical analyses were: non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses. One hundred and forty-two participants (84%; HT = 40/52; NRCT = 44/52; CR = 58/65) had follow-up data of 1-33 months (mean = 26). Overall, 25 (HT = 2, NRCT = 9, CR = 14) of 142 participants (17.6%) presented with at least 1 minor failure (reversible pulpitis, caries progression, or secondary caries; p = 0.013, CI = 0.012-0.018; Mann-Whitney U test). Ten (HT = 1, NRCT = 4, CR = 5) of 142 participants (7.04%) experienced at least 1 major failure (irreversible pulpitis, abscess, unrestorable tooth; p = 0.043, CI = 0.034-0.045). Independent comparisons between 2 samples found that NRCT-CR had no statistically significant difference in failures (p > 0.05), but for CR-HT (p = 0.037, CI = 0.030-0.040) and for NRCT-HT (p = 0.011, CI = 0.010-0.016; Kruskal-Wallis test) significant differences were observed. Cumulative survival rates were HT = 92.5%, NRCT = 70.5%, and CR = 67.2% (p = 0.012). NRCT and CR outcomes were comparable. HT performed better than NRCT and CR for all outcomes. This study was funded by the Paediatric Dentistry Department, Greifswald University, Germany (Trial registration No. NCT01797458).

scholarly journals Role of Topical Cyclosporine in Prevention of Pterygium Recurrence, after Primary Excision

2019 ◽  
Vol 35 (3) ◽  
Author(s):  
Munawar Ahmed, Atif Mansoor Noman Ahmed, Ghazi Khan Mari Azfer Ahmed Mirza
Keyword(s):  
Controlled Trial ◽  
Healing Time ◽  
Complete Healing ◽  
Eye Drops ◽  
Once Daily ◽  
Randomized Controlled ◽  
Department Of Ophthalmology ◽  
Recurrent Pterygium

Purpose: To study the effect of cyclosporine on pterygium recurrence after primary excision Study Design: Non randomized controlled trial. Place and Duration of Study: The study was conducted in the department of Ophthalmology, Liaquat University of Medical and Health Sciences, Jamshoro from 2015 to 2017. Material and Methods: One hundred and thirty eyes of 65 patients having bilateral pterygium, at least 2 mm encroaching on the cornea, were selected for study. Dimensions of pterygium were measured on slit lamp. Half of the eyes were selected for post-operative cyclosporine and was named as cyclo- eye and fellow other eye was named as non-cyclo eye. Immediate post-operative treatment was tobramycin dexamethasone eye ointment twice and moxifloxacin eye drops three times daily until corneal epithelium was restored, followed by moxifloxacin and Cyclosporine eye drops twice daily until complete healing of ocular surface occurred and then cyclosporine 0.05% alone once daily in the evening up to three months. In the fellow eye tobramycin dexamethasone eye ointment and moxifloxacin eye drops were used for complete healing time followed by tears alone three times for three months. Follow up was done for six months. Results: Only Fifty-three patients who completed 6 months of follow-up were included in the results. In cyclo-eyes recurrent pterygium was observed only in 4 (07.55%) and in non-cyclo eyes recurrence was observed in 23 (43.40%) eyes. Mean healing time in cyclo-eyes was 21.1354 days and in non-cyclo-eyes, 15.0213 days. Conclusion: Cyclosporine is effective in reducing the recurrence rate of pterygium. Key Words: Pterygium, Cyclosporine, Cornea.

scholarly journals Universal Adhesives and Adhesion Modes in Non-Carious Cervical Restorations: 2-Year Randomised Clinical Trial

Polymers ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 33
Author(s):  
Patricia Manarte-Monteiro ◽  
Joana Domingues ◽  
Liliana Teixeira ◽  
Sandra Gavinha ◽  
Maria Conceição Manso
Keyword(s):  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Nonparametric Tests ◽  
Retention Rates ◽  
Cervical Lesions ◽  
Double Blind ◽  
Kaplan Meier ◽  
Etch And Rinse ◽  
Universal Adhesives ◽  
Randomised Controlled

This prospective, double-blind, six-arm parallel randomised controlled trial aimed to compare the performance of two universal adhesives (UAs) in non-carious cervical lesions (NCCLs), using the FDI criteria, and analysed if participants/NCCLs’ characteristics influenced the outcome. Thirty-eight 18- to 65-year-old participants were seeking routine dental care at a university clinic. At baseline, 210 NCCLs were randomly allocated to six groups (35 restorations’ each). The UAs tested were FuturabondU (FBU) and AdheseUniversal (ADU) applied in either etch-and-rinse (ER) and self-etch (SE) modes. FuturabondDC (FBDC) in SE and in SE with selective enamel etching (SE-EE) modes were controls. NCCLs were restored with AdmiraFusion. The analysis included nonparametric tests, Kaplan-Meier and log-rank tests (α = 0.05). At 2-years, of 191 restorations, ten were missed due to retention loss (all groups, p > 0.05). FBDC (p = 0.037) and FBU (p = 0.041) performed worse than ADU in SE mode. FBDC and FBU also showed worse functional success rate (p = 0.012, p = 0.007, respectively) and cumulative retention rates (p = 0.022, p = 0.012, respectively) than ADU. Some participants/NCCLs’ characteristics influenced (p < 0.05) the outcomes. FBU did not perform as well as ADU, especially in SE mode and due to functional properties. Participants’ age and NCCLs’ degree of dentin sclerosis and internal shape angle influenced FBU performance.

scholarly journals Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine and prevalence of molecular markers associated with resistance, Guinea: an open-label two-arm randomised controlled trial

2020 ◽  
Author(s):  
Abdoul Habib Beavogui ◽  
Alioune Camara ◽  
Alexandre Delamou ◽  
Abdoulaye Doumbouya ◽  
Karifa Kourouma ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
Molecular Markers ◽  
Randomised Controlled Trial ◽  
Treatment Failure ◽  
Uncomplicated Malaria ◽  
Controlled Trial ◽  
Artemisinin Resistance ◽  
Efficacy And Safety ◽  
Kaplan Meier ◽  
Randomised Controlled

Abstract Background Anti-malarial resistance is a threat to recent gains in malaria control. This study aimed to assess the efficacy and safety of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the management of uncomplicated malaria and to measure the prevalence of molecular markers of resistance of Plasmodium falciparum in sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016.Methods This was a two-arm randomised controlled trial of the efficacy of AL and ASAQ among children aged 6-59 months with uncomplicated Plasmodium falciparum malaria in two sites. Children were followed for 28 days to assess clinical and parasitological response. The primary outcome was the Kaplan-Meier estimate of Day 28 (D28) efficacy after correction by microsatellite-genotyping. Pre-treatment (D0) and day of failure samples were assayed for molecular markers of resistance in the pfk13 and pfmdr1 genes.Results A total of 421 participants were included with 211 participants in the Maferinyah site and 210 in Labé. No early treatment failure was observed in any study arms. However, 22 (5.3%) participants developed a late treatment failure (8 in the ASAQ arm and 14 in the AL arm), which were further classified as 2 recrudescences and 20 reinfections. The Kaplan-Meier estimate of the corrected efficacy at D28 was 100% for both AL and ASAQ in Maferinyah site and 99% (95% Confidence Interval: 97.2-100%) for ASAQ and 99% (97.1-100%) for AL in Labé. The majority of successfully analysed D0 (98%, 380/389) and all day of failure (100%, 22/22) samples were wild type for pfk13. All 9 observed pfk13 mutations were polymorphisms not associated with artemisinin resistance. The NFD haplotype was the predominant haplotype in both D0 (197/362, 54%) and day of failure samples (11/18, 61%) successfully analysed for pfmdr1. Conclusion This study observed high efficacy and safety of both ASAQ and AL in Guinea, providing evidence for their continued use to treat uncomplicated malaria. Continued monitoring of ACT efficacy and safety and molecular makers of resistance in Guinea is important to detect emergence of parasite resistance and to inform evidence-based malaria treatment policies.

scholarly journals Wool-derived keratin dressings versus usual care dressings for treatment of slow healing venous leg ulceration: a randomised controlled trial (Keratin4VLU)

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036476
Author(s):  
Andrew Jull ◽  
Angela Wadham ◽  
Chris Bullen ◽  
Varsha Parag ◽  
Carolina Weller ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Risk Difference ◽  
Complete Healing ◽  
Community Dwelling ◽  
Ulcer Area ◽  
Randomised Controlled

ObjectiveTo determine the effect of a keratin dressing for treating slow-to-heal venous leg ulcers (VLU) on VLU healing.DesignPragmatic parallel group randomised controlled trial.SettingCommunity-dwelling participants.ParticipantsPeople aged 18 or more years with VLU (either present for more than 26 weeks or ulcer area larger than 5 cm2 or both).InterventionWool-derived keratin dressing or usual care formulary of non-medicated dressings, on a background treatment with compression.Primary and secondary outcome measuresHealing at 24 weeks based on blinded assessment of ulcer photographs. Other outcomes included time to complete healing, change in ulcer area to 24 weeks, change in health-related quality of life and incidence of adverse events.ResultsWe screened 1068 patients with VLU and randomised 143 participants (51.1% of target recruitment), 71 to the keratin dressing group and 72 to the usual care group.The mean age was 66.1 years (SD 15.9) and 53 participants (37.1%) were women. There were no significant differences between the groups on the primary outcome (risk difference −6.4%, 95% CI −22.5% to 9.7%), change in ulcer area (−1.9 cm2, 95% CI −16.5 to 12.8 cm2), time to complete healing (HR 0.80, 95% CI 0.52 to 1.23) or the incidence of adverse events (incidence rate ratio 1.19, 95% CI 0.89 to 1.59) in the intention-to-treat analyses. However, the direction of effect on the primary outcome was reversed in a per protocol analysis specified a priori (risk difference 6.2%, 95% CI −12.4% to 24.9%).ConclusionThe effect of adding a keratin dressing to the treatment regimen for prognostically slow-to-heal VLU remains unclear.Trial registration numberNCT02896725

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