EUCTR2013-003867-76-GB
Active, Not Recruiting
Phase 1
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 sites80 target enrollmentSeptember 26, 2013
ConditionsOver-granulation of peritoneal dialysis exit site in patients with End Stage Renal FailureMedDRA version: 18.0 Level: PT Classification code 10034660 Term: Peritoneal dialysis System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.0 Level: LLT Classification code 10008831 Term: Chronic ambulatory peritoneal dialysis System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.0 Level: LLT Classification code 10067974 Term: Automated peritoneal dialysis System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.0 Level: PT Classification code 10067594 Term: Peritoneal dialysis complication System Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 18.0 Level: LLT Classification code 10064116 Term: Continuous ambulatory peritoneal dialysis System Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Biological Phenomena [G16]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Over-granulation of peritoneal dialysis exit site in patients with End Stage Renal Failure
- Sponsor
- niversity Hospitals Birmingham NHS Foundation Trust
- Enrollment
- 80
- Status
- Active, Not Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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