Clinical trial NCT03216824: CVAD-Associated Skin Impairment in Allogeneic Stem Cell Transplant Recipients: Dressing vs No-Dressing
Official title: CVAD-Associated Skin Impairment: A Pilot Study Comparing Dressing to No-Dressing in Adult Allogeneic Stem Cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Line Complication
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: CVAD-associated skin impairment (CASI) rate
timeFrame: 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:
measure: CVAD-related bloodstream infection (CRBSI) rate
timeFrame: All episodes of CRBSI will be captured during the six week study follow-up period.
measure: Rate of moderate and severe CVAD-associated skin impairment (CASI)
timeFrame: 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:
measure: Feasibility Outcome 1: Enrollment rate
timeFrame: 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.
measure: Feasibility Outcome 2: Time to complete enrollment
timeFrame: 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.
measure: Feasibility Outcome 3: CASI assessment completion rate
timeFrame: 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.
measure: Feasibility Outcome 4: Reasons for lack of compliance with CASI assessment
timeFrame: 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.
measure: Feasibility Outcome 5: Total number of duplicate CASI assessments
timeFrame: 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.
measure: Feasibility Outcome 6: Rate of discordant findings for duplicate CASI assessments
timeFrame: 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.
measure: Feasibility Outcome 7: Rate of discordant findings for individual elements for duplicate CASI assessments
timeFrame: 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.
measure: Feasibility Outcome 8: Missing data rate
timeFrame: Data will be collected from the date 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.
measure: Feasibility Outcome 9: Type of missing data
timeFrame: Data will be collected from the date 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.
measure: Feasibility Outcome 10: Participant-dependent compliance
timeFrame: The "Participant Feedback Survey" is completed once. The time point is the last study visit. Survey collection will occur over a planned time period of 16 weeks.
measure: Feasibility Outcome 11: Duration of Follow-Up
timeFrame: Data will be collected from the start of enrollment until the final visit of the last participant enrolled in the study. The planned time period is 22 weeks.
measure: Feasibility Outcome 12: Reasons for Early Withdrawal
timeFrame: Data will be collected from the start of enrollment until the final visit of the last participant enrolled in the study. The planned time period is 22 weeks.
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Wendy A. Hall, PhD
role: PRINCIPAL_INVESTIGATOR
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