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

NCT03216824 | Completed

• 1 other identifier: H17-01002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Central Line Complication

Outcome Measures

Primary Outcomes (1)

• CVAD-associated skin impairment (CASI) rate

  CASI is defined as: chemical, mechanical or microbiological damage to the skin occurring within a 7 cm radius of a CVAD exit site (i.e. the "CASI boundary area"). Skin damage will be measured using a modified ECOG Skin Toxicity Scale. The scale has five levels of measurement with "0" = no CASI, and "1, 2, 3 and 4" corresponding to increasing levels of CASI severity. A finding of CASI of any severity will be counted as one episode of CASI. The rate of CASI will be reported as total CASI episodes.

  The first CASI assessment will occur within one week of randomization. CASI assessments will be conducted every seven days with up to six assessments in total (i.e. the study follow-up period is six weeks).

Secondary Outcomes (2)

• CVAD-related bloodstream infection (CRBSI) rate

  All episodes of CRBSI will be captured during the six week study follow-up period.

• Rate of moderate and severe CVAD-associated skin impairment (CASI)

  The first CASI assessment will occur within one week of randomization. CASI assessments will be conducted every seven days with up to six assessments in total.

Other Outcomes (12)

• Feasibility Outcome 1: Enrollment rate

  Enrollment data will be collected from the start date of enrollment until the date that the total number of required participants has been enrolled. The planned time period is 16 weeks.

• Feasibility Outcome 2: Time to complete enrollment

  Enrollment data will be collected from the start date of enrollment until the date 26th participant is enrolled. The planned time period is 16 weeks.

• Feasibility Outcome 3: CASI assessment completion rate

  CASI assessment data will be collected from the start of enrollment until the date of the final CASI assessment for the last participant enrolled in the study. The planned time period is 22 weeks.

Study Arms (2)

Dressing

ACTIVE COMPARATOR

A dressing is maintained on the CVAD exit site.

Other: Dressing

No-Dressing

EXPERIMENTAL

The CVAD exit site is not covered with a dressing.

Other: No-Dressing

Interventions

Dressing OTHER

A dressing is maintained on the CVAD exit site.

Dressing

No-Dressing OTHER

The CVAD exit site is not covered with a dressing.

No-Dressing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9., Canada

Location

Related Publications (20)

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MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Wendy A. Hall, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group will maintain a dressing on the CVAD exit site as per institutional practice. The second group will not cover the CVAD exit site with a dressing (i.e. no-dressing).

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: July 13, 2017
• Study Start: September 14, 2017
• Primary Completion: November 4, 2018
• Study Completion: November 4, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)