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

University of British Columbia

Status

Completed

Conditions

Central Line Complication

Treatments

Other: Dressing

Other: No-Dressing

Study type

Interventional

Funder types

Other

Identifiers

NCT03216824

H17-01002

Details and patient eligibility

About

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).

Full 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.

Enrollment

24 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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)