Peritoneal DialysisPhase 3STOPNCT01996930
Steroid Impregnated Tape in the Treatment of Over-granulating Peritoneal Dialysis Exit Sites
A Phase 3 study testing Haelan tape (steroid impregnated tape) and Silver Nitrate in people with Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis, run by University Hospital Birmingham NHS Foundation Trust at 8 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis, Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Failure
- What is being tested?
- Haelan tape (steroid impregnated tape) and Silver Nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Dec 2013to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX2 5DW
Hull and East Yorkshire Hospitals NHS Trust
Hull, HU3 2JZ
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
University Hospital of North Staffordshire NHS Trust
Stoke-on-Trent, ST4 6QG
About this study
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
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.
Read the 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.
- Conditions
- Peritoneal Dialysis, Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Failure, Chronic Renal Failure
- Being tested
- Haelan tape (steroid impregnated tape), Silver Nitrate
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haelan tape (steroid impregnated tape)Drug
Also called MA PL00551/0014
Medicated plaster applied daily. Max daily dose = 0.1mg (25cm squared per day)Maximum duration of treatment = 28 days
Silver NitrateDrug
Also called Avoca Caustic Applicator 95% w/w cutaneous stick, MA PL04286/0005
Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days
| Study group | Role | What they receive |
|---|---|---|
| Haelan tape (steroid impregnated tape) | Active comparator | 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 Receives: Drug: Haelan tape (steroid impregnated tape) |
| Silver nitrate | Active comparator | Avoca caustic applicator 95% w/w cutaneous stick Cautery with silver nitrate cutaneous stick undertaken twice weekly Maximum duration of treatment = 28 days Receives: Drug: Silver Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate in over-granulation severity
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
Measured: 14 days
Secondary outcomes (6)
Partial response rate of over-granulation to treatment
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
Measured: 14 days and 28 days
Recurrence of over-granulation
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.
Measured: at 28 days and 56 days
Exit site infection rate
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)
Measured: within 28 days and 56 days
Exit site swab results
At defined time points the exit site will be swabbed by trained staff to detect the presence of micro-organisms
Measured: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
Patient reported pain, discomfort and satisfaction score
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.
Measured: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
Occurrence of redness, ulceration or infection using a standardised exit site assessment tool
The local investigators will assess the exit site at protocol defined study visits using a standardised exit site assessment tool.
Measured: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lukas Foggensteiner, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Lukas Foggensteiner, BM FRCP PhD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996930
- Sponsor's protocol ID
- RRK 4249
- Other IDs
- 2013-003867-76
- Acronym
- STOP
- Status last verified
- Oct 2017
- First submitted
- 21 Nov 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01996930
- Acronym / sponsor ID
- STOP / RRK 4249
- Conditions
- Peritoneal Dialysis, Continuous Ambulatory Peritoneal Dialysis, End Stage Renal Failure, Chronic Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haelan tape (steroid impregnated tape) | Active comparator | Drug: 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 |
| Silver nitrate | Active comparator | Drug: Silver NitrateAvoca caustic applicator 95% w/w cutaneous stick Cautery with silver nitrate cutaneous stick undertaken twice weekly Maximum duration of treatment = 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haelan tape (steroid impregnated tape)Also: MA PL00551/0014Medicated plaster applied daily. Max daily dose = 0.1mg (25cm squared per day)Maximum duration of treatment = 28 days | Drug | Haelan tape (steroid impregnated tape) |
| Silver NitrateAlso: Avoca Caustic Applicator 95% w/w cutaneous stick, MA PL04286/0005Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days | Drug | Silver nitrate |
Primary outcome
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
6 secondary outcomes
Partial response rate of over-granulation to treatment
Time frame: 14 days and 28 days
Recurrence of over-granulation
Time frame: at 28 days and 56 days
Exit site infection rate
Time frame: within 28 days and 56 days
Exit site swab results
Time frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
Patient reported pain, discomfort and satisfaction score
Time frame: Baseline (Day 0), Day 7, Day 14, Day 21, Day 28 and Day 56
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Foggensteiner, BM FRCP PhD principal investigator
University Hospital Birmingham NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haelan tape (steroid impregnated tape) and Silver Nitrate in people with Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis, run by University Hospital Birmingham NHS Foundation Trust at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate in over-granulation severity (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.