The extremely resorbed mandible, 10-year results of a randomized controlled trial on 3 treatment strategies

2013 ◽  
Vol 25 (8) ◽  
pp. 926-932 ◽  
Author(s):  
Kees Stellingsma ◽  
Gerry M. Raghoebar ◽  
Anita Visser ◽  
Arjan Vissink ◽  
Henny J. A. Meijer
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Randomized Controlled

scholarly journals The coArtHA trial—identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Herry Mapesi ◽  
Ravi Gupta ◽  
Herieth Ismael Wilson ◽  
Blaise Lukau ◽  
Alain Amstutz ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Arterial Hypertension ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Link Type ◽  
Sub Saharan

Abstract Background Arterial hypertension is the most prevalent risk factor for cardiovascular disease in sub-Saharan Africa. Only a few and mostly small randomized trials have studied antihypertensive treatments in people of African descent living in sub-Saharan Africa. Methods In this open-label, three-arm, parallel randomized controlled trial conducted at two rural hospitals in Lesotho and Tanzania, we compare the efficacy and cost-effectiveness of three antihypertensive treatment strategies among participants aged ≥ 18 years. The study includes patients with untreated uncomplicated arterial hypertension diagnosed by a standardized office blood pressure ≥ 140/90 mmHg. The trial encompasses a superiority comparison between a triple low-dose antihypertensive drug combination versus the current standard of care (monotherapy followed by dual treatment), as well as a non-inferiority comparison for a dual drug combination versus standard of care with optional dose titration after 4 and 8 weeks for participants not reaching the target blood pressure. The sample size is 1268 participants with parallel allocation and a randomization ratio of 2:1:2 for the dual, triple and control arms, respectively. The primary endpoint is the proportion of participants reaching a target blood pressure at 12 weeks of ≤ 130/80 mmHg and ≤ 140/90 mmHg among those aged < 65 years and ≥ 65 years, respectively. Clinical manifestations of end-organ damage and cost-effectiveness at 6 months are secondary endpoints. Discussion This trial will help to identify the most effective and cost-effective treatment strategies for uncomplicated arterial hypertension among people of African descent living in rural sub-Saharan Africa and inform future clinical guidelines on antihypertensive management in the region. Trial registration Clinicaltrials.govNCT04129840. Registered on 17 October 2019 (https://www.clinicaltrials.gov/).

scholarly journals Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Andreas Älgå ◽  
Sidney Wong ◽  
Rawand Haweizy ◽  
Kalle Conneryd Lundgren ◽  
Johan von Schreeb ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Negative Pressure ◽  
Negative Pressure Wound Therapy ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Treatment Strategies ◽  
Wound Complications ◽  
Wound Therapy ◽  
Intention To Treat ◽  
Randomized Controlled

BACKGROUND In armed conflict, injuries commonly affect the extremities and contamination with foreign material often increases the risk of infection. The use of negative-pressure wound therapy has been described in the treatment of acute conflict-related wounds, but reports are retrospective and with limited follow-up. OBJECTIVE The objective of this study is to investigate the effectiveness and safety of negative-pressure wound therapy use in the treatment of patients with conflict-related extremity wounds. METHODS This is a multisite, superiority, pragmatic randomized controlled trial. We are considering for inclusion patients 18 years of age and older who are presenting with a conflict-related extremity wound within 72 hours after injury. Patients are block randomly assigned to either negative-pressure wound therapy or standard treatment in a 1:1 ratio. The primary end point is wound closure by day 5. Secondary end points include length of stay, wound infection, sepsis, wound complications, death, and health-related quality of life. We will explore economic outcomes, including direct health care costs and cost effectiveness, in a substudy. Data are collected at baseline and at each dressing change, and participants are followed for up to 3 months. We will base the primary statistical analysis on intention-to-treat. RESULTS The trial is ongoing. Patient enrollment started in June 2015. We expect to publish findings from the trial by the end of 2019. CONCLUSIONS To the best of our knowledge, there has been no randomized trial of negative-pressure wound therapy in this context. We expect that our findings will increase the knowledge to establish best-treatment strategies. CLINICALTRIAL ClinicalTrials.gov NCT02444598; http://clinicaltrials.gov/ct2/show/NCT02444598 (Archived by WebCite at http://www.webcitation.org/72hjI2XNX) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12334

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