Clinical trial NCT01996930: Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Failure
Chronic Renal Failure
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Complete response rate in over-granulation severity
timeFrame: 14 days
Secondary outcomes:
measure: Partial response rate of over-granulation to treatment
timeFrame: 14 days and 28 days
measure: Recurrence of over-granulation
timeFrame: at 28 days and 56 days
measure: Exit site infection rate
timeFrame: within 28 days and 56 days
measure: Exit site swab results
timeFrame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
measure: Patient reported pain, discomfort and satisfaction score
timeFrame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
measure: Occurrence of redness, ulceration or infection using a standardised exit site assessment tool
timeFrame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28, Day 56
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Stoke on Trent
country: United Kingdom
facility: University Hospital of North Staffordshire NHS Trust
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Lukas Foggensteiner, BM FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References: