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For triclosan‐coated sutures, the WHO guidelines made a conditional recommendation for use based on moderate-quality evidence available. There were five randomised controlled trials from middle-income countries (Brazil, India, and Thailand with 1755 patients in total), all of which were at high risk of bias. Of 17 randomised trials, only one was high quality (849 patients, one country, clean-contaminated surgery only).
Flacon medical skin#
The recommendation from the WHO Global Guidelines for the Prevention of Surgical Site Infection (November, 2016) of alcoholic chlorhexidine solution for surgical skin preparation was based on evidence of low-to-moderate quality. With both strata combined, there were no differences using alcoholic chlorhexidine or triclosan-coated sutures. For both strata, there was no evidence of a difference in the risk of SSI with alcoholic chlorhexidine versus povidone–iodine (clean-contaminated stratum 15♳% vs 15♷%, relative risk 0♹7 contaminated or dirty stratum 28♳% vs 31♸%, relative risk 0♹1 ), or with triclosan-coated sutures versus non-coated sutures (clean-contaminated stratum 14♷% vs 16♳%, relative risk 0♹0 contaminated or dirty stratum 29♴% vs 30♷%, relative risk 0♹8 ). The overall SSI rate was 22♰% (1163/5284 clean-contaminated stratum 15♵%, contaminated or dirty stratum 30♰% ).
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Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening.Kidney or any other solid organ transplant recipient or a planned transplant during the study.Serum albumin Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit.B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit.History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screen A visit.Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at Screen A visit after a period of rest.Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit.Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to≤ 90 mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70 years):ġ) Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥ 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion) 2)The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference ≤ 25%
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Diagnosis of ADPKD by modified Pei-Ravine criteria: 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history.Male and female patients 12 ≤ age ≤ 70 upon study consent.Why Should I Register and Submit Results?.
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