Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites

Last updated: October 31, 2017
Sponsor: University Hospital Birmingham NHS Foundation Trust
Overall Status: Completed

Phase

3

Condition

Kidney Failure

Kidney Failure (Pediatric)

Nephropathy

Treatment

N/A

Clinical Study ID

NCT01996930
RRK 4249
2013-003867-76
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has been established on PD for > 3 months

  • Subject has an over-granulating exit site judged to require treatment according tostandard (appendix 1)

  • If patient has exit site infection, they must currently be treated with antibioticsand the site must be clinically improving.

  • Subject is > 18 years of age

  • Subject is able to give informed consent

Exclusion

Exclusion Criteria:

  • Subject has had peritonitis treated in the previous month

  • Subject has been treated with silver nitrate or topical steroids in the previous 2weeks

  • Subject is receiving oral steroids

  • Patient is unable to give informed consent

  • Patient is participating in a clinical trial of an intervention relating to PDcatheters.

  • Subject is pregnant or unwilling to use an effective method of contraception duringthe course of the study

Study Design

Total Participants: 32
Study Start date:
December 01, 2013
Estimated Completion Date:
March 31, 2017

Study 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.

Connect with a study center

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH
    United Kingdom

    Site Not Available

  • Royal Devon & Exeter NHS Foundation Trust

    Exeter, EX2 5DW
    United Kingdom

    Site Not Available

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Royal Liverpool & Broadgreen University Hospitals NHS Trust

    Liverpool,
    United Kingdom

    Site Not Available

  • Central Manchester University Hospitals NHS Foundation Trust

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield,
    United Kingdom

    Site Not Available

  • University Hospital of North Staffordshire NHS Trust

    Stoke on Trent, ST4 6QG
    United Kingdom

    Site Not Available

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