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

University Hospital Birmingham NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Continuous Ambulatory Peritoneal Dialysis; Chronic Renal Failure; Peritoneal Dialysis; End Stage Renal Failure

Treatments: Drug: Haelan tape (steroid impregnated tape); Drug: Silver Nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01996930

2013-003867-76 (EudraCT Number)

RRK 4249

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Haelan tape (steroid impregnated tape)

Active Comparator group

Description:

Haelan tape, medicated tape for cutaneous use, containing 4mcg Fludroxycortide per centimetre squared. Maximum daily dosage of 0.1mg = 25cm squared per day. Application = once daily and left in situ for 24 hours Maximum duration of treatment = 28 days

Treatment:

Drug: Haelan tape (steroid impregnated tape)

Silver nitrate

Active Comparator group

Description:

Avoca caustic applicator 95% w/w cutaneous stick Cautery with silver nitrate cutaneous stick undertaken twice weekly Maximum duration of treatment = 28 days

Treatment:

Drug: Silver Nitrate