Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Hospital Birmingham NHS Foundation Trust
This study will be a United Kingdom wide multi-centre trial. A minimum of 40 patients in each arm will be recruited. Subjects will be identified using a standardised exit site assessment tool by PD nurses in participating units during the routine care of their PD population. Any subject with an over-granulating exit site deemed to meet the agreed standard for treatment will be invited to participate.
Therapy will be administered for two weeks followed by an additional two weeks if clinically indicated. Treatment must be according to randomisation for the first 28 days. If after 14 days the over-granulation is worse than at day 0, then a medical decision to continue treatment may be taken. A further two weeks of the designated treatment may then be administered although this can be discontinued at any point if a satisfactory clinical response is observed.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has been established on PD for \> 3 months
Subject has an over-granulating exit site judged to require treatment according to standard (appendix 1)
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
You may not be if
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
