Trial record 2 of 96 for:    Open Studies | "Peritoneal Dialysis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital Birmingham NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Dr. Lukas Foggensteiner, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01996930
First received: November 21, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Peritoneal Dialysis
Continuous Ambulatory Peritoneal Dialysis
End Stage Renal Failure
Chronic Renal Failure
Drug: Haelan tape (steroid impregnated tape)
Drug: Silver Nitrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • Complete response rate in over-granulation severity [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    The primary research objective of this study is to assess the total response at 14 days to treatment with either steroid tape or silver nitrate therapy on the over-granulated tissue surrounding the PD exit site.

    Assessment is by two blinded independent investigators (patient and therapy administrators will not be blinded to the therapy received). At each of the study visits, a series of photographs will be taken according to a study specific standard operating procedure and the two assessors will score the exit sites from the photographic series. There is no standardised scoring system for over-granulating exit sites so a scale has been devised:

    Score 1: Complete response:complete disappearance of over-granulation Score 2: Partial response: reduction in size or an obvious reduction in intensity of over-granulation Score 3: No change, appearance identical to that of pre-treatment Score 4: Worse, increase in size or increased intensity of over-granulation



Secondary Outcome Measures:
  • Partial response rate of over-granulation to treatment [ Time Frame: 14 days and 28 days ] [ Designated as safety issue: No ]

    Partial response rate of over-granulation to treatment by either silver nitrate or steroid impregnated tape will assessed by two blinded independent investigators (patient and therapy administrators will not be blinded to the therapy received). At each of the study visits, a series of photographs will be taken according to a study specific standard operating procedure and the two assessors will score the exit sites from the photographic series. There is no standardised scoring system for over-granulating exit sites so a scale has been devised:

    Score 1: Complete response:complete disappearance of over-granulation Score 2: Partial response: reduction in size or an obvious reduction in intensity of over-granulation Score 3: No change, appearance identical to that of pre-treatment Score 4: Worse, increase in size or increased intensity of over-granulation


  • Recurrence of over-granulation [ Time Frame: at 28 days and 56 days ] [ Designated as safety issue: No ]
    Following treatment, what is the rate of recurrence of over-granulation tissue at Day 28 and Day 56 of the study. The local investigators will assess the exit site at protocol defined study visits using a standardised exit site assessment tool.

  • Exit site infection rate [ Time Frame: within 28 days and 56 days ] [ Designated as safety issue: Yes ]
    Following treatment, what is the rate of exit site infections within 28 and 56 days (An exit site infection is defined as occurring when a clinician decides treatment with antibiotics is required)

  • Exit site swab results [ Time Frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56 ] [ Designated as safety issue: Yes ]
    At defined time points the exit site will be swabbed by trained staff to detect the presence of micro-organisms

  • Patient reported pain, discomfort and satisfaction score [ Time Frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56 ] [ Designated as safety issue: No ]
    The study will assess patient reported pain and discomfort as well as satisfaction in terms of convenience and ease of use, with the treatment they received to treat their over-granulation tissue, through completion of a short non-validated patient questionnaire.

  • Occurrence of redness, ulceration or infection using a standardised exit site assessment tool [ Time Frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28, Day 56 ] [ Designated as safety issue: No ]
    The local investigators will assess the exit site at protocol defined study visits using a standardised exit site assessment tool.


Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

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
Other Names:
  • Halean
  • MA PL00551/0014
Active Comparator: 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
Drug: Silver Nitrate
Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days
Other Names:
  • Avoca Caustic Applicator 95% w/w cutaneous stick
  • MA PL04286/0005

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996930

Contacts
Contact: Nicola E Anderson, MSc BA RN 4407769648885 nicola.anderson@uhb.nhs.uk

Locations
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Lukas Foggensteiner, BSc BM PhD FRCP         
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Graham Woodrow, MB ChB MRCP MD FRCP         
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Investigators
Principal Investigator: Lukas Foggensteiner, BM FRCP PhD University Hospital Birmingham NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr. Lukas Foggensteiner, Consultant Nephrologist, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01996930     History of Changes
Other Study ID Numbers: RRK 4249, 2013-003867-76
Study First Received: November 21, 2013
Last Updated: May 23, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Silver Nitrate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014