NCT01996930

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Hospital Birmingham NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2013-11-27
• Last updated: 2017-11-06

Locations

8 sites across 1 country: United Kingdom