Recruiting

Polysporin Ointment

Sponsor:

University Health Network, Toronto

Code:

NCT02002169

Conditions

End Stage Renal Failure on Dialysis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shower Technique Protocol

Standard CVC Care

Study Details

Brief summary:

Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis (HD) patients with healed central venous catheter (CVC) exit sites, designed to permit showering but not increase infection risk.

Research question: Is it feasible to conduct a randomized control trial comparing the rate of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC care alone with 6 month follow up? Study Design: This pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to STP versus standard care after meeting predefined criteria to confirm healed tunneled CVC exit site.

Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of the CRB rate documentation in the satellite setting, percentage of patients screened, recruited, educated successfully in the STP (intervention arm), and aspects of STP (% of contaminated patients in the control arm).

Study Setting: In satellite units affiliated with 2 academic and 3 community centres in south central Ontario, Canada.

Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit sites.

Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each measure of feasibility has its statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.

Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and contamination.

Conditions

End Stage Renal Failure on Dialysis

Study ID

NCT02002169

Start date

Dec, 2012

Status verified date

Dec, 2013

Completion date

Nov, 2014

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Informed written consent obtained (English speaking)
  • Age >18 years
  • Requires a CVC as the vascular access: a) end stage kidney disease without a functioning surgically created access; b) end stage kidney disease whose peritoneal dialysis problems require transfer to HD for an anticipated prolonged period
  • Passed 2/3 tests of CVC exit site healing (see below)
  • Must be willing and able to take a shower as the standard form of body cleansing if randomized to STP
  • Trisodium citrate (4%) as standard CVC locking solution
  • CVC has been in situ for > 6 weeks

Exclusion criteria

  • Acute kidney failure, likely to be reversible with recovery of renal function
  • Non-Tunneled CVC
  • Antibiotic use by any route in the week prior to enrolling in the study, including intranasal mupirocin
  • On immunosuppressant therapy
  • Use of the CVC for purposes other than access for hemodialysis
  • Involvement in another interventional study related to their vascular access
  • CVC or patient life expectancy <6 months (e.g. active malignancy; serious comorbidity such as hepatic failure)
  • Routine use of tissue plasminogen activator or antibiotic as a locking solution
  • CVC insertion in location other than the neck/chest region (IJ or subclavian acceptable)

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Shower Technique Protocol (STP)

Participants will be given a minimum 30 minute personalized educational session by the study coordinator. They will be taught safe and clean techniques for showering with their CVC. If the participant passes the Shower Technique Test, they will be provided a pamphlet on the STP, not to be shared with other participants, to be kept as a reference and placed in their bathroom/household. They will also be given the necessary supplies for the STP.

active comparator: Standard CVC care

Standard CVC Care consists of cleansing with chlorhexidine 2% or povidone (if allergic to chlorhexidine) at the CVC exit site by trained HD nurses followed by placement of a dry gauze dressing by the HD nurse 1x/week or when clinically indicated. In order to participate in the standard CVC care arm, participating sites must have in their policy that it is trained HD nurses who will apply the Polysporin Triple Ointment after standard cleansing with chlorhexidine 2% or povidone during HD, according to guideline recommendations or as per hospital patient care standards and nursing regulations.

Interventions

Shower Technique Protocol

Video and educational pamphlets of the STP will be used to assist in training participants randomized to this intervention. The participant must successfully demonstrate the STP on a training mannequin and be deemed by the study coordinator as ready to independently and correctly perform it before proceeding.

Standard CVC Care

Nuanced differences may be present at participating units; however, the key components of the intervention are 1) HD nurse delivery of CVC care 2) chlorhexidine or povidone cleansing 3) dry gauze dressing 4) standardized frequency. For both STP and control arms, participants whose HD centre uses polysporin triple ointment as part of standard CVC care will continue to have it applied as per program policy.

Primary outcome measure

  • Primary Feasibility Measure of the HIPPO SAT trial: Defined by 5 outcomes [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Daisy Kosa, MSc. (c)

(905) 745-4773sarah.kosa@uhn.ca

Cathy Forrester, R.N.

(416) 340-4140cathy.forrester@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M4N 2C4

Contacts

S Daisy Kosa, BHSc

(905) 745-4773sarah.kosa@uhn.ca

Cathy Forrester, RN

(416) 340-4800cathy.forrester@uhn.ca

Principal Investigator:

Charmaine E Lok, MD, MSc

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 10, 2013

Last verified

Dec, 2013

Keywords

  • Catheter Related Bacteremia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2013-12-10.