Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01996930
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Lukas Foggensteiner, University Hospital Birmingham NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
Complete response rate in over-granulation severity [ Time Frame: 14 days ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
Complete response rate in over-granulation severity [ Time Frame: 14 days ]
The primary research objective of this study is to assess the total response at 14 days to treatment with either steroid impregnated tape (Haelan tape) or silver nitrate therapy on the over-granulated tissue surrounding the PD catheter exit site.
Change History Complete list of historical versions of study NCT01996930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
  • Partial response rate of over-granulation to treatment [ Time Frame: 14 days and 28 days ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    The local investigators will assess the exit site at protocol defined study visits using a standardised exit site assessment tool.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • Partial response rate of over-granulation to treatment [ Time Frame: 14 days and 28 days ]
    Partial response rate of over-granulation to treatment by either silver nitrate or steroid impregnated tape (Haelan tape)
  • Recurrence of over-granulation [ Time Frame: at 28 days and 56 days ]
    Following treatment, what is the rate of recurrence of over-granulation tissue at Day 28 and Day 56 of the study.
  • Exit site infection rate [ Time Frame: within 28 days and 56 days ]
    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 ]
    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 ]
    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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Peritoneal Dialysis
  • Continuous Ambulatory Peritoneal Dialysis
  • End Stage Renal Failure
  • Chronic Renal Failure
Intervention  ICMJE
  • 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 Name: MA PL00551/0014
  • 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
Study Arms  ICMJE
  • 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

    Intervention: Drug: Haelan tape (steroid impregnated tape)
  • 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
    Intervention: Drug: Silver Nitrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
80
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996930
Other Study ID Numbers  ICMJE RRK 4249
2013-003867-76 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Lukas Foggensteiner, University Hospital Birmingham NHS Foundation Trust
Study Sponsor  ICMJE University Hospital Birmingham NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lukas Foggensteiner, BM FRCP PhD University Hospital Birmingham NHS Foundation Trust
PRS Account University Hospital Birmingham NHS Foundation Trust
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP