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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust
• Treatments: Flurandrenolone; Silver Nitrate

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