Infection, BacterialNCT04800575
Comparison of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Central Venous Catheter
A study testing semi-permeable film and sterile gauze and tape in people with Infection, Bacterial, run by Peking University People's Hospital at 1 site in China.
Trial summary
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- semi-permeable film and sterile gauze and tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years; requiring hemodialysis treatment by non-tunneled CVC inserted through subclavian vein, femoral vein, internal jugular vein by nephrologists team, allowing sufficient blood flow; competent to provide informed consent.
Who cannot join
- current systemic antibiotic therapy as a result of bacteremia in the previous 21 days; pregnancy; with a known dermatitis at the exit site or known hypersensitivity to a component of either dressing; require antibiotic lock or antibiotic ointment in exit-site for infection prevention locally
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Junqing Liang, Graduate, +8615201091164, yinpin777@126.com
Weilin Zhang
About this study
Official title: Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
Read the detailed description
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 1:1 ratio. Experiment group use semi-permeable film as dressing in exit-site of CVC, and a sterile gauze and tape in control group. Both groups share same disinfection and dressing change procedure. Dressings will be replaced per hemodialysis session, or as needed. Socio-demographic data and disease-related information will be collected, as well as catheterization site, physician, skin and exit status of the catheterization site at baseline. Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session, such as sign of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation and dryness, dressing intactness. Before the 2nd dressing change, skin around exit of CVC under dressing area will be swabbed by a cotton swab. Nursing time of dressing change will be recorded by a third nurses. Cost and benefit will be calculated and compared by the end.
- Conditions
- Infection, Bacterial
- Being tested
- semi-permeable film, sterile gauze and tape
- Keywords
- hemodialysis, Semi-permeable film
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-permeable filmDevice
Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.
sterile gauze and tapeDevice
Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.
| Study group | Role | What they receive |
|---|---|---|
| Semi-permeable film dressing | Experimental | Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off. Receives: Device: semi-permeable film |
| sterile gauze and tape dressing | Other | Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off. Receives: Device: sterile gauze and tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
exit-site infection
redness, tenderness, swelling and/or with exudation within 2 cm around exit of CVC in the skin
Measured: before disinfectant and dressing change at every hemodialysis session within 2 weeks
Secondary outcomes (5)
catheter-related blood stream infection(CRBSI)
At least one blood culture from peripheral venous puncture was collected at CVC removal and whenever a catheter-related infection or other type of sepsis was suspected (temperature 38.2°C or 36.5°C or chills, leukocytes 10,000 or 4,000, or other signs of sepsis according the diagnosis of CDC
Measured: within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
skin erythema and dryness under the dressing area
The following scale was used for erythema [modified from Fitzpatrick et al. (20)]: 0 ¼ none; 0.5 ¼ equivocal erythema; 1 ¼ slight redness, spotty and diffuse; 2 ¼ moderate uniform redness; 3 ¼ intense redness; 4 ¼ fiery red with oedema.The following scale was used for dryness:0 ¼ none; 1 ¼ slight scaling, dryness; 2 ¼ moderate scaling, dryness; 3 ¼ severe dryness with large flakes. The sum score of dryness and erythema over all assessment times served as outcome parameter.
Measured: before disinfectant and dressing change at every hemodialysis session within 2 weeks
total bacterial count
cotton swab in skin within 2 cm around the exit-site of CVC under the dressing
Measured: Once only. At the time of the 2nd dressing change after CVC insertion of each patient(dressing change usually happened at each hemodialysis therapy session)
dressing intactness
if all the corners or edges of dressing is intact, count how many corners or edges rolled up or fell off
Measured: before disinfectant and dressing change at every hemodialysis session within 2 weeks
nursing time for dressing change
how much time a dressing change procedure cost in minutes. Nursing time are recorded by other nurse using a clock while the nurse change dressing for a patient.the whole time cost of the nurse doing dressing change should be the outcome.
Measured: at any of the session, once only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start17 May 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Junqing, Peking University People's Hospital
- Investigators
- Liangying Gan, Study director, Department of Nephrology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800575
- Sponsor's protocol ID
- RDN2020-02
- Status last verified
- Sep 2021
- First submitted
- 9 Mar 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Sterile Gauze and Semi-permeable Film Dressing for Hemodialysis Non-tunneling Central Venous Catheter
- ClinicalTrials.gov ID
- NCT04800575
- Acronym / sponsor ID
- RDN2020-02
- Conditions
- Infection, Bacterial
- Keywords
- hemodialysis, Semi-permeable film
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
Detailed description
This prospective single center RCT aims to compare sterile gauze and tape versus Semi-permeable film dressing on the incidence of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation, total bacterial count, dressing intactness and cost-benefit, nursing workload in hemodialysis patients with a non-tunneled hemodialysis catheter.
154 eligible patients in our HD center will be enrolled consecutively and randomly allocated to one of the two groups according to computer-generated randomization sequences in a 1:1 ratio. Experiment group use semi-permeable film as dressing in exit-site of CVC, and a sterile gauze and tape in control group. Both groups share same disinfection and dressing change procedure. Dressings will be replaced per hemodialysis session, or as needed. Socio-demographic data and disease-related information will be collected, as well as catheterization site, physician, skin and exit status of the catheterization site at baseline. Data as listed in the beginning will be recorded in the next 2 weeks follow-up at every session, such as sign of exit-site infection, CRBSIs (catheter-related bloodstream infections), skin irritation and dryness, dressing intactness. Before the 2nd dressing change, skin around exit of CVC under dressing area will be swabbed by a cotton swab. Nursing time of dressing change will be recorded by a third nurses. Cost and benefit will be calculated and compared by the end.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semi-permeable film dressing | Experimental | Device: semi-permeable filmExperiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off. |
| sterile gauze and tape dressing | Other | Device: sterile gauze and tapeControl group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age more than 18 years; requiring hemodialysis treatment by non-tunneled CVC inserted through subclavian vein, femoral vein, internal jugular vein by nephrologists team, allowing sufficient blood flow; competent to provide informed consent.
Key exclusion criteria (1 listed)
- current systemic antibiotic therapy as a result of bacteremia in the previous 21 days; pregnancy; with a known dermatitis at the exit site or known hypersensitivity to a component of either dressing; require antibiotic lock or antibiotic ointment in exit-site for infection prevention locally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi-permeable filmExperiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off. | Device | Semi-permeable film dressing |
| sterile gauze and tapeControl group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off. | Device | sterile gauze and tape dressing |
Primary outcome
exit-site infection
Time frame: before disinfectant and dressing change at every hemodialysis session within 2 weeks
redness, tenderness, swelling and/or with exudation within 2 cm around exit of CVC in the skin
5 secondary outcomes
catheter-related blood stream infection(CRBSI)
Time frame: within 2-week follow-up or before withdrawn of hemodialysis therapy if the patient cannot reach 2 weeks
skin erythema and dryness under the dressing area
Time frame: before disinfectant and dressing change at every hemodialysis session within 2 weeks
total bacterial count
Time frame: Once only. At the time of the 2nd dressing change after CVC insertion of each patient(dressing change usually happened at each hemodialysis therapy session)
dressing intactness
Time frame: before disinfectant and dressing change at every hemodialysis session within 2 weeks
nursing time for dressing change
Time frame: at any of the session, once only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangying Gan study director
Department of Nephrology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semi-permeable film and sterile gauze and tape in people with Infection, Bacterial, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junqing Liang, Graduate (+8615201091164 ext. 8832, yinpin777@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exit-site infection (time frame: before disinfectant and dressing change at every hemodialysis session within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.