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Efficacy of alternative dressing and securement options for peripherally inserted central catheters (PICCs) in the prevention of PICC failure and infection. the PISCES Trial

Factorial, superiority, randomised controlled trial testing alternative (1) dressing (chlorhexidine impregnated disc) and (2) securement (integrated securement device) to prevent PICC failure and catheter associated bloodstream infection in cancer patients: the PISCES Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000315415
Acronym
The PISCES trial
Enrollment
1027
Registered
2016-03-10
Start date
2016-06-14
Completion date
2020-09-01
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to evaluate the efficacy of alternative dressing and securement devices in preventing device failure and infection in peripherally inserted central catheters (PICCs) in cancer patients. You may be eligible to participate in this trial if you are a cancer patient of any age, with a haematological malignancy or solid tumour, and are having a PICC inserted as part of your therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of four PICC dressing/securement device combinations. These combinations are the standard securement device with a simple polyurethane dressing; the standard securement device with a simple polyurethane dressing and a chlorhexidine impregnated disc; an integrated securement device and simple polyurethane dressing combined into a single device; or an integrated securement device and chlorhexidine impregnated disc. The allocated dressing will be re-applied every 7 days or more frequently if required, until 8 weeks or until the time of device removal if removal is required earlier. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PICC securement devices and dressings are most effective in preventing PICC failure and infection in cancer patients.

Interventions

Participants in this study will have peripherally inserted central catheters (PICCs) used in cancer care services departments, including adult and paediatric populations. Consenting patients will have their PICC dressed and secured with one of the following randomly assigned options: Arm 1 (Control): Securement device (SSD) and simple polyurethane dressing (SP). Arm 2: Securement device; simple polyurethane dressing and a chlorhexidine impregnated (CHG) disc. Arm 3: Integrated securement devi

Participants in this study will have peripherally inserted central catheters (PICCs) used in cancer care services departments, including adult and paediatric populations. Consenting patients will have their PICC dressed and secured with one of the following randomly assigned options: Arm 1 (Control): Securement device (SSD) and simple polyurethane dressing (SP). Arm 2: Securement device; simple polyurethane dressing and a chlorhexidine impregnated (CHG) disc. Arm 3: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both SP and SD into one product. Arm 4: Integrated securement device and a chlorhexidine impregnated disc. Patients will be monitored daily to ensure protocol adherence. The randomly allocated dressing will be applied regularly every 7 days or as clinically indicated until either removal of device or until 8 weeks after device insertion (at which point the allocated dressing/securement will be removed and replaced with standard care).

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

1. Cancer patient (haematological malignancy or solid tumour) 2. PICC scheduled/expected use >24 hours 3. Informed written consent To ensure generalisability, PICCs inserted after-hours will also be studied if the following additional inclusion criteria are met: 4. <24 hours since PICC insertion 5. The treating clinician agree it is safe to replace the initial dressing/securement.

Exclusion criteria

1. Other CVC insertion (not PICC) 2. Current bloodstream infection (<48 hours) 3. PICC inserted through burned or diseased skin 4. Known allergy to any study product 5. Non-English speaking patients without interpreter 6, CHG disc/dressing already in place.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026