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Trial registered on ANZCTR


Registration number
ACTRN12617000110381
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
20/01/2017
Date last updated
12/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
SurgiSeal (Registered Trademark) (medical adhesive) to prevent ooze and early dressing failure for Peripherally Inserted Central Catheters (PICCs) (The STICC randomised controlled trial)
Scientific title
SurgiSeal (Registered Trademark) versus standard care (no adhesive) to achieve haemostasis and prevent early dressing failure among adult and paediatric patients requiring Peripherally Inserted Central Catheters (PICCs). (The STICC randomised controlled trial)
Secondary ID [1] 290946 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The STICC Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post PICC insertion bleeding/ooze 301679 0
PICC dressing failure 301702 0
Condition category
Condition code
Public Health 301386 301386 0 0
Health service research
Infection 301387 301387 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will have Peripherally Inserted Central Catheters (PICCs) used in adult and paediatric tertiary care settings. The dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserted the PICC).
Arm 1 (Control) (Standard Care: A polyurethane dressing and a sutureless stabilisation device. Within the adult setting a chlorhexidine gluconate-impregnated disc will also be applied.

Arm 2 (Intervention - TA): 2-3 drops (<1ml) of a tissue adhesive (TA) (SurgiSeal (Registered Trademark); Adhezion) at the PICC insertion site and standard care (a polyurethane dressing and a sutureless stabilisation device). Within the adult setting a chlorhexidine gluconate-impregnated disc will also be applied.

The randomly allocated grouping of products will be applied at the time of PICC insertion. TA (if allocated) will not be re-applied (once-only application). To maintain protocol fidelity, each participant will be visited on the day of insertion (during 1st dressing application), ensuring they receive the correct dressing allocation. (TA is not generally available in the tertiary ward setting at the recruiting sites so unintended re-application of TA is not expected.) The patient will also be assessed by the Research Nurse 24 hours later, and then assessed bi-weekly for the first week following PICC insertion to collect data on primary outcomes.

Participants will continue to have (minimum) weekly site cleaning and dressing changes (as per policy (7 days) and clinical indication (<7 days)) until the device is removed. All changes (after the initial dressing change) are subsequently uncontrolled.
Intervention code [1] 296891 0
Treatment: Other
Intervention code [2] 296893 0
Prevention
Comparator / control treatment
Control group patient will have their PICCs secured with a polyurethane dressing and a sutureless stabilisation device. (Within the adult setting a chlorhexidine gluconate-impregnated disc will also be applied.)
Control group
Active

Outcomes
Primary outcome [1] 300783 0
Early dressing failure: Delayed haemostasis at PICC insertion site, defined as requirement for PICC dressing replacement within 24 hours due to visible blood ooze.
Timepoint [1] 300783 0
24 hours following device insertion.
Primary outcome [2] 300784 0
Blood presence at PICC insertion wound: Amount (in cm) of blood ooze at insertion site.
Timepoint [2] 300784 0
24 hours following device insertion.
Secondary outcome [1] 330843 0
All-cause PICC failure: premature removal for any of: occlusion, infiltration [or extravasation], dislodgement, thrombosis, fracture, haematoma, local or catheter-associated bloodstream infection).
Timepoint [1] 330843 0
At the time of PICC removal.
Secondary outcome [2] 330851 0
PICC-associated bloodstream infection (CABSI): A laboratory confirmed BSI that is not secondary to an infection at another body site (excludes Mucosal Barrier Injury LCBSI), with PICC in place for >2 calendar days on the day of the BSI (day of PICC placement being Day 1) and the PICC was in place on the date of the event or the day before, when all elements of LCBI, were first present together (see CDC NHSN for full criteria) confirmed by a blinded infectious disease specialist using de-identified clinical and microbiological data.
Timepoint [2] 330851 0
At the time of PICC removal.
Secondary outcome [3] 330852 0
Local infection: Purulent phlebitis confirmed with a positive (>15cfu) swab, but with negative or no blood culture, confirmed by blinded infectious disease specialist.
Timepoint [3] 330852 0
At 24 hours;
Bi-weekly for the first week; and
At the time of PICC removal.
Secondary outcome [4] 330853 0
Occlusion: Complete: One (or more) lumen cannot be flushed or aspirated, or resolved post thrombolytic dwell, Partial: use of thrombolytic.
Timepoint [4] 330853 0
At the time of PICC removal.
Secondary outcome [5] 330854 0
Fracture: Visible split in PICC material with leakage or radiographic evidence of extravasation/infiltration into tissue, in a PICC formerly flushed to clear occlusion.
Timepoint [5] 330854 0
At the time of PICC removal.
Secondary outcome [6] 330855 0
Venous thrombosis: suspected: too painful for the patient to tolerate, or Confirmed Ultrasound/venographic confirmed thrombosed vessel at the PICC site in a symptomatic patient, or a symptomatic patient with a thrombus/fibrin sheath occluding one (or more) lumen at PICC removal.
Timepoint [6] 330855 0
At the time of PICC removal.
Secondary outcome [7] 330856 0
Safety endpoints: Any local or systemic allergic reactions (e.g. pruritis) and serious adverse events (e.g., intensive care admission).
Timepoint [7] 330856 0
At 24 hours after PICC insertion until the time of PICC removal. If an adverse event occurs the patient will be monitored until the skin reaction has resolved.
Secondary outcome [8] 330857 0
PICC and first dressing dwell time: hours from insertion/application until removal.
Timepoint [8] 330857 0
At 24 hours;
Bi-weekly for the first week; and
At the time of PICC removal.
Secondary outcome [9] 330858 0
Catheter tip colonization: (>15cfu)
Timepoint [9] 330858 0
At the time of PICC removal.
Secondary outcome [10] 330859 0
Patient / parent and staff acceptability: using 0-10 numeric rating scales.
Timepoint [10] 330859 0
At 7 days following PICC insertion.
Secondary outcome [11] 330860 0
Healthcare costs: Estimates of direct product costs, healthcare resource utilisation (including additional equipment, staff time) and failure-associated resource usage using previously established cost estimates.
Timepoint [11] 330860 0
At the time of trial completion.

Eligibility
Key inclusion criteria
Require PICC insertion for fluid or medication administration;
Likely to remain an inpatient for 24 hours (or more);
Able to provide informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous enrolment in the current study this admission;
Other vascular access types (e.g., jugular central venous access device);
Current catheter-related bloodstream infection;
PICC to be inserted through diseased, burned, hirsute, broken or impaired skin (e.g., burn) at the PICC site;
Allergy to any study product; and
Non-English speaking without an interpreter.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research nurses (ReNs) will screen patients daily and liaise heavily with the staff responsible for inserting the majority of PICCs (radiology staff, vascular access specialists, medical registrars and anaesthetists). All eligible patients (or their representative) will be approached for written informed consent by the ReN or inserter. If this is given, the staff member will log in to a centralised web-based randomisation service customised for the trial and be advised of group allocation. Computer generated allocation is provided by an independent randomisation service. Allocation is fully concealed until the patient is randomised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation: Randomisation will be in a 1:1 ratio between the two study groups (stratification by hospital site).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To detect significantly reduced dressing failure (replacement within 24 hours) in the TA group by 25% (from 75% in the standard care group to 50% in the TA group), a superiority design requires 74 patients per group with 90% power (p=0.05). Allowing 10% for potential drop outs/cross overs, we will recruit 82 patients/group. All randomised patients will be analysed by intention to treat, irrespective of treatment. Any protocol deviations will be reported and a per protocol analysis also undertaken to assess the potential effect of these. Descriptive statistics will be used to describe the sample and to compare groups at baseline. Chi-square/Fisher’s Exact Test will be used to compare the frequency of early dressing failure between groups. PICC failure will be compared between groups using incidence rates per 1000 catheter days (95% confidence intervals). Incidence rate ratios will be calculated and Kaplan Meier curves drawn with failure between groups compared using the log rank test. A multivariable Cox logistic regression will explore the effects of group, hospital site, baseline patient and PICC characteristics, and potential confounders. Costs will be assessed considering purchase price, staff time and the costs of treating complications, compared with a statistical test appropriate for the observed distribution of costs. Values of p=0.05 will be considered significant for all analyses. Data will be exported into Stata (College Station, TX: StataCorp LP).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
164
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7334 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 7335 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 15120 0
4029 - Herston
Recruitment postcode(s) [2] 15121 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 295371 0
Commercial sector/Industry
Name [1] 295371 0
Adhezion Biomedical, LLC
Country [1] 295371 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 294194 0
None
Name [1] 294194 0
Not Applicable
Address [1] 294194 0
Not Applicable
Country [1] 294194 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296701 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 296701 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Ethics committee country [1] 296701 0
Australia
Date submitted for ethics approval [1] 296701 0
28/11/2016
Approval date [1] 296701 0
22/12/2016
Ethics approval number [1] 296701 0
HREC/16/QRCH/370
Ethics committee name [2] 296702 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 296702 0
Office for Research (Bray Centre)
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Ethics committee country [2] 296702 0
Australia
Date submitted for ethics approval [2] 296702 0
04/01/2017
Approval date [2] 296702 0
09/01/2017
Ethics approval number [2] 296702 0
NRS/2017/016

Summary
Brief summary
The primary aim of this study is to identify clinical, cost-effective methods to promote haemostasis and prevent PICC dressing failure and associated workloads. The randomised controlled trial also aims to compare current PICC dressing techniques with tissue adhesive (TA) in terms of haemostasis, dressing duration, workload and healthcare costs; and evaluate the acceptability of this product to paediatric and adult patients and health professionals.

You may be eligible to participate in this trial if you are receiving treatment in a tertiary health-care setting and a receiving a Peripherally Inserted Central Catheter (PICC) as part of your prescribed care (no age limits).

All participants enrolled in this trial will be randomly allocated (by chance) to receive (1) standard care with tissue adhesive (TA) at the PICC insertion site or (2) standard care (with no tissue adhesive).

If you are allocated to the Tissue Adhesive (TA) group, the medical-grade glue will be applied at the time of PICC insertion only (one-time application). All participants: standard care dressing and securement will continue to be applied (routinely or as clinically indicated) from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine dressing changes, side effects, device failures and infections. It is hoped that the findings of this trial will provide information of the efficacy and acceptability of medical-grade tissue adhesive to promote haemostatis at the PICC insertion site (to prevent early dressing failure).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71810 0
Prof Claire Rickard
Address 71810 0
Menzies Health Institute Queensland
Griffith University, Nathan campus
170 Kessels Road
Nathan, QLD 4111
Country 71810 0
Australia
Phone 71810 0
+61737356460
Fax 71810 0
+61737355431
Email 71810 0
[email protected]
Contact person for public queries
Name 71811 0
Emily Larsen
Address 71811 0
Centre for Clinical Nursing (Nursing and Midwifery Research Centre)
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 71811 0
Australia
Phone 71811 0
+61736468725
Fax 71811 0
Email 71811 0
[email protected]
Contact person for scientific queries
Name 71812 0
Claire Rickard
Address 71812 0
Menzies Health Institute Queensland
Griffith University, Nathan campus
170 Kessels Road
Nathan, QLD 4111
Country 71812 0
Australia
Phone 71812 0
+61737356460
Fax 71812 0
+61737355431
Email 71812 0
[email protected]

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No Supporting Document Provided



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