Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres Pilot Study

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• Scarborough General Hospital

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• Trillium Health Centre

  collaborator OTHER

• York Central Hospital, Ontario

  collaborator OTHER

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Charmaine Lok, MD, MSc · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-07-31

Completion

2014-11-30

Countries

• Canada

Study Locations