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

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ClinicalTrials.gov Identifier: NCT03216824
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wendy Hall, University of British Columbia

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).

Condition or disease Intervention/treatment Phase
Central Line Complication Other: Dressing Other: No-Dressing Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CVAD-Associated Skin Impairment: A Pilot Study Comparing Dressing to No-Dressing in Adult Allogeneic Stem Cell Transplant Recipients
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Active Comparator: Dressing
A dressing is maintained on the CVAD exit site.
Other: Dressing
A dressing is maintained on the CVAD exit site.

Experimental: No-Dressing
The CVAD exit site is not covered with a dressing.
Other: No-Dressing
The CVAD exit site is not covered with a dressing.




Primary Outcome Measures :
  1. CVAD-associated skin impairment (CASI) rate [ Time Frame: 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). ]
    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.


Secondary Outcome Measures :
  1. CVAD-related bloodstream infection (CRBSI) rate [ Time Frame: All episodes of CRBSI will be captured during the six week study follow-up period. ]
    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.

  2. Rate of moderate and severe CVAD-associated skin impairment (CASI) [ Time Frame: 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. ]
    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.


Other Outcome Measures:
  1. Feasibility Outcome 1: Enrollment rate [ Time Frame: 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. ]
    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.

  2. Feasibility Outcome 2: Time to complete enrollment [ Time Frame: 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. ]
    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.

  3. Feasibility Outcome 3: CASI assessment completion rate [ Time Frame: 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. ]
    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.

  4. Feasibility Outcome 4: Reasons for lack of compliance with CASI assessment [ Time Frame: 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. ]
    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.

  5. Feasibility Outcome 5: Total number of duplicate CASI assessments [ Time Frame: 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. ]
    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.

  6. Feasibility Outcome 6: Rate of discordant findings for duplicate CASI assessments [ Time Frame: 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. ]
    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).

  7. Feasibility Outcome 7: Rate of discordant findings for individual elements for duplicate CASI assessments [ Time Frame: 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. ]
    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).

  8. Feasibility Outcome 8: Missing data rate [ Time Frame: 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. ]
    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.

  9. Feasibility Outcome 9: Type of missing data [ Time Frame: 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. ]
    Specific data items with a missing data rate > 5% will be identified. A feasibility threshold has not been established for this outcome.

  10. Feasibility Outcome 10: Participant-dependent compliance [ Time Frame: 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. ]
    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.

  11. Feasibility Outcome 11: Duration of Follow-Up [ Time Frame: 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. ]
    If > 20% of participants are withdrawn from the study prior to week six, then this will be considered a significant feasibility issue.

  12. Feasibility Outcome 12: Reasons for Early Withdrawal [ Time Frame: 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. ]
    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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216824


Contacts
Contact: Holly M. Kerr, R.N. 604-875-4111 ext 54073 Holly.Kerr@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9.
Contact: Holly M. Kerr, R.N.    604-875-4111 ext 54073    Holly.Kerr@vch.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Wendy A. Hall, PhD University of British Columbia

Publications:
Keeler, M., Haas, B., Northam, S., Nieswiadomy, M., McConnel, C., & Savoie, L. Analysis of costs and benefits of transparent, gauze, or no dressing for a tunnelled central venous catheter in Canadian stem cell transplant recipients. Canadian Oncology Nursing Journal. 25(3): 289-298, 2015.
Orsino, L., Bargelli, A., Cappucciati, L., Fanchin, G., Galati, G., Manzin, F., ... Vendemiati, S. Observational study of SorbaView® 2000, SorbaView® ultimate and SecureView® port AFZ dressings used on central venous catheters in eleven italian oncology, hematology and pain centers. Journal of the Association for Vascular Access, 14(1): 14-19, 2009.

Responsible Party: Wendy Hall, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03216824     History of Changes
Other Study ID Numbers: H17-01002
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No