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NCT03216824 Clinical Trial

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

Central Line Complication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03216824
Other study ID # H17-01002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2017
Est. completion date November 4, 2018

Study information
Verified date October 2019
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

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Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Dressing
A dressing is maintained on the CVAD exit site.
• No-Dressing
The CVAD exit site is not covered with a dressing.

Locations
Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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Outcome
Type Measure Description Time frame Safety issue
Other Feasibility Outcome 1: Enrollment rate The enrollment rate will be determined by calculating the ratio of participants enrolled to the number of potentially eligible prospective participants invited to participate. The ratio will be reported as a percentage. It will be considered a feasibility concern if > 30% of potentially eligible prospective participants are not enrolled in the study. 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.
Other Feasibility Outcome 2: Time to complete enrollment The number of days from the start of enrollment to the end of enrollment (i.e. date 26th participant enrolled) will be calculated. An enrollment period that is > 25% longer than 16 weeks is considered a feasibility concern. 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.
Other Feasibility Outcome 3: CASI assessment completion rate The CASI assessment completion rate will be determined by calculating the ratio of completed CASI Assessment Forms to required CASI assessments. The CASI Assessment Form includes a 1:1 scale diagram of the CASI boundary area, a key that can be used to indicate specific type(s) of skin impairment on the diagram, and the modified ECOG Skin Toxicity Scale. The CASI assessment completion rate will be expressed as a percentage. A completion rate < 95% is considered a feasibility concern. 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.
Other Feasibility Outcome 4: Reasons for lack of compliance with CASI assessment The reasons for not completing the CASI Assessment Form will be categorized as: (1) error; (2) participant refused; (3) lack of nurse/researcher time; (4) lack of participant time; (5) participant absent; and (6) other. The frequency of each reason will be reported. A feasibility threshold has not been established for this outcome. 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.
Other Feasibility Outcome 5: Total number of duplicate CASI assessments A duplicate CASI assessment is scheduled to occur with every fifth CASI assessment in order to assess whether or not consistent data is captured using the CASI Assessment Form. It is possible some scheduled duplicate assessments may not occur. The intention of this outcome is to determine the number of duplicate CASI assessments performed. A feasibility threshold has not been established for this outcome. 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.
Other Feasibility Outcome 6: Rate of discordant findings for duplicate CASI assessments The ratio of total discordant findings in general to total findings in general with respect to the duplicate CASI Assessment Forms completed will be calculated and expressed as a percentage. If it is found that the discordant findings rate is > 10% this will be considered a feasibility concern (i.e. revision and further testing of the CASI Assessment Form is needed). 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.
Other Feasibility Outcome 7: Rate of discordant findings for individual elements for duplicate CASI assessments The ratio of discordant findings to total findings for each element of the CASI Assessment Form will be calculated and expressed as a percentage. If it is found that the discordant findings rate is > 10% for a specific element of the CASI Assessment Form, then this will be considered a feasibility concern (i.e. revision and further testing of this specific element in the CASI Assessment Form is needed). 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.
Other Feasibility Outcome 8: Missing data rate The missing data rate will be determined by calculating the ratio of missing data values to total possible data items. The result will be expressed as a percentage. Missing data > 10% is considered a serious feasibility issue. 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.
Other Feasibility Outcome 9: Type of missing data Specific data items with a missing data rate > 5% will be identified. A feasibility threshold has not been established for this outcome. 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.
Other Feasibility Outcome 10: Participant-dependent compliance Participants will be asked to complete a "Participant Feedback Survey" to assess their degree of compliance with study procedures. The survey includes four questions answered using a Likert scale (1-5). Mean scores will be calculated for each question. Mean scores which indicates a feasibility concern have been established a priori for each question. 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.
Other Feasibility Outcome 11: Duration of Follow-Up If > 20% of participants are withdrawn from the study prior to week six, then this will be considered a significant feasibility issue. 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.
Other Feasibility Outcome 12: Reasons for Early Withdrawal The reasons for early withdrawal will be reported by frequency according to the following categories: cuff extrusion; absolute neutrophil count < 0.5 x 10^9/L for > 7 consecutive days; temperature greater than or equal to 38 degrees Celsius at one or more time points for > 3 consecutive days; CVAD removed due to positive blood cultures or no longer needed; admission to hospital for a period > 14 days; participant withdrawal from the study. A feasibility threshold has not been established for this outcome. 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.
Primary 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 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.
Secondary 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.
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