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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


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 treatment

Recurrence 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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

Page last updated: August 20, 2015

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