CVAD-Associated Skin Impairment in Allogeneic Stem Cell Transplant Recipients: Dressing vs No-Dressing

NCT ID: NCT03216824

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2018-11-04

Brief Summary

Central venous access device (CVAD)-associated skin impairment (CASI) is a common problem in allogeneic hematopoietic stem cell transplant (HSCT) recipients. In this prospective randomized pilot study, dressing the CVAD exit site will be compared to no-dressing with respect to CASI and CVAD-related bloodstream infection (CRBSI) rates in adult outpatient HSCT recipients. The purpose of this study is to gain information that can be used to design a large randomized controlled trial (RCT).

Detailed Description

Central venous access device (CVAD)-associated skin impairment (CASI) is common in adult allogeneic hematopoietic stem cell (HSCT) recipients. CASI is defined as chemical, mechanical or microbiological damage to the skin occurring within a 7 cm radius of a CVAD exit site. CASI is associated with discomfort, complex dressing changes, and increased infection risk due to disruption of skin barrier function. Allogeneic hematopoietic stem cell transplant (HSCT) recipients receiving post-transplant care in the outpatient HSCT setting may be at higher risk of CASI. No-dressing of embedded tunneled CVAD (T-CVAD) exit sites may decrease CASI without increased risk of CVAD-related bloodstream infection (CRBSI), but no studies have been conducted to test this hypothesis. A pilot study will determine the practicality of testing this hypothesis. The proposed pilot study will be conducted at an outpatient HSCT clinic located at a large tertiary hospital. The primary aim is to evaluate the logistics of comparing no-dressing to dressing in the outpatient adult allogeneic HSCT population. A total of 26 allogeneic HSCT recipients will be enrolled. Enrollment will commence once the following conditions are met: REB approval, institutional approval, and assignment of an NCT ID number. Eligible participants will have embedded T-CVADs, be within 35 to 60 days of transplant, meet criteria for neutrophil engraftment, and be without pre-existing severe CASI. Participants will be randomized to either a dressing or no-dressing group. A modified version of the Eastern Cooperative Oncology Group (ECOG) skin toxicity scale will be used to grade CASI at baseline and weekly for up to six weeks. Primary and secondary endpoints will be tested statistically to generate estimates of effect size and standard deviations, for the purpose of future study design. Information useful for planning large-scale studies will be reported, such as enrollment metrics, participant compliance, procedure fidelity, and missing data characteristics. Feedback will be collected from participants regarding their study experience.

Conditions

Central Line Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dressing

A dressing is maintained on the CVAD exit site.

Group Type: ACTIVE_COMPARATOR

Dressing

Intervention Type: OTHER

A dressing is maintained on the CVAD exit site.

No-Dressing

The CVAD exit site is not covered with a dressing.

Group Type: EXPERIMENTAL

No-Dressing

Intervention Type: OTHER

The CVAD exit site is not covered with a dressing.

Interventions

Dressing

A dressing is maintained on the CVAD exit site.

Intervention Type: OTHER

No-Dressing

The CVAD exit site is not covered with a dressing.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Able to provide informed consent
• 19 years of age or over
• Recipient of an allogeneic HSCT (sibling, haploidentical, or unrelated donor) within the past 35-60 days
• Receiving post-allogeneic HSCT follow-up care at the outpatient HSCT clinic at the study centre
• Possessing a tunneled CVAD with cuff (either Hickman™, Leonard™ or Broviac™) inserted greater than 40 days prior to screening visit
• An embedded T-CVAD exit site (i.e. subcutaneous tissue attached to the internal cuff and prior removal of the exit site suture)
• Documented neutrophil engraftment
• Free of temperature equal to or greater than to 38° C in the past seven days

Exclusion Criteria

• An infection requiring systemic IV therapy within the last seven days
• A history of abdominal abscess or endocarditis
• Active discharge and/or bleeding from the T-CVAD exit site
• Severe CASI (i.e. greater than grade 3 as per the Modified ECOG Skin Toxicity Scale)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Wendy Hall

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy A. Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

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Other Identifiers

H17-01002

Identifier Type: -

Identifier Source: org_study_id