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

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.

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 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 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.

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.

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.

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.

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.

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).

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).

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.

Specific data items with a missing data rate > 5% will be identified. A feasibility threshold has not been established for this outcome.

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.

If > 20% of participants are withdrawn from the study prior to week six, then this will be considered a significant feasibility issue.

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.