A prospective, randomised controlled trial to determine the safety and efficacy of steroid impregnated tape compared to standard therapy with silver nitrate in the treatment of over-granulating peritoneal dialysis catheter exit sites - Steroid tape to treat overgranulating PD exit sites

niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 80 人开始时间: 2013年9月26日最近更新: 2019年6月30日

适应症

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•Inclusion criteria;
•Subject has been established on Peritoneal Dialysis for > 3 months
•Subject has an over-granulating exit site judged to require treatment according to standard
•If patient has exit site infection, they must currently be treated with antibiotics and the site must be clinically improving.
•Subject is > 18 years of age
•Subject is able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Exclusion criteria;
•Subject has had peritonitis treated in the previous month
•Subject has been treated with silver nitrate or topical steroids in the previous 2 weeks
•Subject is receiving oral steroids
•Patient is unable to give informed consent
•Patient is participating in a clinical trial of an intervention relating to PD catheters.
•Subject is pregnant or unwilling to use an effective method of contraception during the course of the study

发起方

niversity Hospitals Birmingham NHS Foundation Trust