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

NCT01996930 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-11-06

No results posted yet for this 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.

Conditions

  • Peritoneal Dialysis
  • Continuous Ambulatory Peritoneal Dialysis
  • End Stage Renal Failure
  • Chronic Renal Failure

Interventions

DRUG

Haelan tape (steroid impregnated tape)

Medicated plaster applied daily. Max daily dose = 0.1mg (25cm squared per day)Maximum duration of treatment = 28 days

DRUG

Silver Nitrate

Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days

Sponsors & Collaborators

  • University Hospital Birmingham NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Lukas Foggensteiner, BM FRCP PhD · University Hospital Birmingham NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01996930 on ClinicalTrials.gov