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

NCT ID: NCT01996930

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Haelan tape (steroid impregnated tape)

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

Group Type ACTIVE_COMPARATOR

Haelan tape (steroid impregnated tape)

Intervention Type DRUG

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

Silver nitrate

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

Group Type ACTIVE_COMPARATOR

Silver Nitrate

Intervention Type DRUG

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

Interventions

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Haelan tape (steroid impregnated tape)

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

Intervention Type DRUG

Silver Nitrate

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

Intervention Type DRUG

Other Intervention Names

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MA PL00551/0014 Avoca Caustic Applicator 95% w/w cutaneous stick MA PL04286/0005

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr. Lukas Foggensteiner

Consultant Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukas Foggensteiner, BM FRCP PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham NHS Foundation Trust

Locations

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University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Site Status

Royal Devon & Exeter NHS Foundation Trust

Exeter, , United Kingdom

Site Status

Hull and East Yorkshire Hospitals NHS Trust

Hull, , United Kingdom

Site Status

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Royal Liverpool & Broadgreen University Hospitals NHS Trust

Liverpool, , United Kingdom

Site Status

Central Manchester University Hospitals NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, , United Kingdom

Site Status

University Hospital of North Staffordshire NHS Trust

Stoke-on-Trent, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2013-003867-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RRK 4249

Identifier Type: -

Identifier Source: org_study_id