Title: 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.
Funder: Department of Health (England)

Abstract: Background Peritoneal dialysis (PD) involves instilling dialysate into the peritoneal cavity through a catheter. The majority of the complications of PD relate to this catheter and include the formation of overgranulation tissue at the point of entry through the skin. Histologically, overgranulation tissue consists of a disorganised and exuberant granulation response with varying degrees of inflammation. It appears as the presence of protuberant, moist red tissue around the exit site. Lesions are painful and easily become infected[11]. Infected exit sites are a significant risk factor for infection of the peritoneal cavity which carries a high risk of PD modality failure and is associated with a significant mortality[6]. Overgranulation at the PD exit site occurs in 5% of the PD population per year and represents a significant practical clinical challenge. Conventional practice No randomised controlled trials of treatment of overgranulating PD exit sites exist. Conventional treatment recommended by the International Society of PD is with topical silver nitrate to achieve chemical cautery of the lesion[15]. This requires careful and repeated application by trained staff 2-3 times per week for 2-4 weeks. Complications include failure to respond, chemical burns to healthy skin and pain during application. Suggested alternatives include topical steroids but these are difficult to apply, fail to adhere to the wet lesion and are rarely used. There is also concern that steroids may increase susceptibility to infection or impair healing. Pilot Study An alternative to topical steroid ointments is steroid impregnated dressings. One such dressing (Haelan tape) consists of an occlusive material impregnated with 4 µg/cm2 fludroxycortide. This product is licensed for use in eczema and has been used in overgranulation of tracheostomy tubes with anecdotal success[16]. The tape can be cut to the dimensions of the lesion ensuring targeted treatment. Once applied the active ingredient is released over a 24 hours. A pilot study of Haelan tape was undertaken in the Queen Elizabeth Hospital Birmingham in which 15 consecutive patients with overgranulating exit sites were treated. Patients were instructed in applying the product and then self-applied the tape daily over 2-4 weeks. Response rate was 90% with low recurrence. One exit site infection was observed following treatment but no other significant complications were recorded and patient satisfaction was high. Proposed study We propose a prospective multicentre RCT over 36 months comparing silver nitrate with Haelan tape in the treatment of overgranulating PD exit sites. This study has been reviewed by the UK Renal Association PD Clinical Research Group and has their support. Patients would be randomised to receive silver nitrate or Haelan tape over 4 weeks with 8 weeks follow-up. The primary endpoint is response to treatment assessed by serial photography of the lesions scored by a blinded assessor. Secondary endpoints include exit site scoring using a validated scoring tool, patient satisfaction and exit site infection. The risk of promoting infection by applying a corticosteroid to exit sites remains unknown and this concern represents a significant question of the proposed study. Benefits to patients and NHS The pilot study suggested that Haelan tape treatment is at least as effective as silver nitrate with significant advantages. These include the elimination of complications such as pain and skin burns. Visits to the PD unit are substantially reduced in frequency and shortened resulting in significant savings in nursing time. The cost of the tape is low and comparable to silver nitrate. The proposed study seeks to validate the use of Haelan tape in this context and would provide the international PD community with a valuable treatment option underpinned by robust evidence.


Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RENAL AND UROGENITAL