Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites
Information source: University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peritoneal Dialysis; Continuous Ambulatory Peritoneal Dialysis; End Stage Renal Failure; Chronic Renal Failure
Intervention: Haelan tape (steroid impregnated tape) (Drug); Silver Nitrate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Hospital Birmingham NHS Foundation Trust Official(s) and/or principal investigator(s): Lukas Foggensteiner, BM FRCP PhD, Principal Investigator, Affiliation: University Hospital Birmingham NHS Foundation Trust
Overall contact: Nicola E Anderson, MSc BA RN, Phone: 4407769648885, Email: nicola.anderson@uhb.nhs.uk
Summary
Kidney failure is a devastating illness requiring treatment with dialysis or transplantation
to preserve life. Individuals unable to have transplants are managed by peritoneal dialysis
(PD)or haemodialysis (HD). PD involves the placement of a soft, flexible plastic tube
(catheter) into the abdomen, allowing dialysis fluid to be drained in and out of the
peritoneal cavity. This catheter exits from a hole in the abdomen and occasionally patients
can have complications at this exit site. One possible complication is over-granulation.
Over-granulation occurs as the wound attempts to heal and the skin around the exit site
becomes red,'wet','bumpy' and stands 'proud' of the surrounding skin. An over-granulating
exit site can lead to discomfort, pain, bleeding and harbour infection. More serious
complications include dialysis failure, sepsis and death. There are several ways to treat
over-granulation but there is limited research evidence to demonstrate which treatment is
best. The study aims to compare current standard treatment which involves the application of
silver nitrate by qualified nursing staff to chemically burn the tissue away, with an
alternative treatment which involves the application of steroid impregnated tape to the area
of over-granulating tissue by the patient themselves.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Complete response rate in over-granulation severity
Secondary outcome: Partial response rate of over-granulation to treatmentRecurrence of over-granulation Exit site infection rate Exit site swab results Patient reported pain, discomfort and satisfaction score Occurrence of redness, ulceration or infection using a standardised exit site assessment tool
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
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
Locations and Contacts
Nicola E Anderson, MSc BA RN, Phone: 4407769648885, Email: nicola.anderson@uhb.nhs.uk
University Hospitals Birmingham NHS Foundation Trust, Birmingham B15 2TH, United Kingdom; Recruiting Lukas Foggensteiner, BSc BM PhD FRCP, Principal Investigator
Hull and East Yorkshire Hospitals NHS Trust, Hull HU3 2JZ, United Kingdom; Active, not recruiting
Leeds Teaching Hospitals NHS Trust, Leeds LS9 7TF, United Kingdom; Recruiting Graham Woodrow, MB ChB MRCP MD FRCP, Principal Investigator
Central Manchester University Hospitals NHS Foundation Trust, Manchester M13 9WL, United Kingdom; Recruiting Helen Hurst, PhD, Principal Investigator
Nottingham University Hospitals NHS Trust, Nottingham NG7 2UH, United Kingdom; Not yet recruiting Gavin McHaffie, Principal Investigator
University Hospital of North Staffordshire NHS Trust, Stoke on Trent ST4 6QG, United Kingdom; Recruiting Simon Davies, Principal Investigator
Additional Information
Starting date: December 2013
Last updated: December 5, 2014
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