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

Study Overview
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Brief Summary
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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
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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.

Official Title
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CVAD-Associated Skin Impairment: A Pilot Study Comparing Dressing to No-Dressing in Adult Allogeneic Stem Cell Transplant Recipients

Conditions
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Central Line Complication

Intervention / Treatment
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* Other: Dressing
* Other: No-Dressing


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dressing<br>A dressing is maintained on the CVAD exit site. | Other: Dressing<br>* A dressing is maintained on the CVAD exit site.<br>|
| Experimental: No-Dressing<br>The CVAD exit site is not covered with a dressing. | Other: No-Dressing<br>* The CVAD exit site is not covered with a dressing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CVAD-related bloodstream infection (CRBSI) rate | CRBSI is defined as a bloodstream infection linked to a CVAD using a laboratory method with high sensitivity and specificity. In this study differential time to positivity (DTP) will be used to confirm CRBSI. Concomitant peripheral and CVAD blood cultures will be drawn at the new onset of a temperature equal to or greater than 38° C. A set of cultures in which the CVAD culture turns positive two or more hours before a positive peripheral culture will be considered one episode of CRBSI. The rate of CRBSI will be reported according to the number of CRBSI episodes per 1,000 catheter days. | 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) | All episodes of CASI that meet the modified ECOG Skin Toxicity Scale criteria for levels 2, 3 or 4 will be included to calculate the rate of moderate and severe 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. |