CancerPICCandGLUENCT05944900
Study Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone in Patients With Cancer.
A study testing Cyanoacrylate glue application in people with Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
This is a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Cyanoacrylate glue application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2023to 19 Jul 2024
- 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
- Male or female, 18 years of age or older on the date of signature the informed consent form
- Patient with a histological diagnosis of cancer
- Indication for central line chemotherapy or immunotherapy
- Placement of a single-lumen PICC in the non-tunneled upper limb planned on an ambulatory basis at the Centre
- Planned duration of PICC use > 30 days
- Dated and signed informed consent, indicating that the patient has been informed of all relevant aspects of the study prior to inclusion;
- Patient covered by a health insurance plan
Who cannot join
- Patient already included in the study ;
- Patient with known allergy to cyanoacrylates, Violet D\&C or formaldehyde;
- Patient not reachable by telephone ;
- Patient under guardianship;
- Patient does not speak French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Prospective, Single-center Trial Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone (Without Glue) in Patients With Cancer.
This is a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in cancer patients.
Read the detailed description
Peripherally Inserted Central Catheters (PICCs) are a form of vascular access inserted percutaneously into a vein, usually in the arm, with the distal end at the atrio cava junction (between the superior vena cava and the right atrium). They may be used for a prolonged period or for several days, repeatedly over time (as is the case for certain chemotherapies, parenteral nutrition or long-term intravenous treatments).
Their placement requires aseptic surgical conditions, and a team trained in the procedure, sometimes grouped together in a Vascular Access Unit (UAV).
A PICC is inserted by puncturing the skin and subcutaneous tissues, and securing the catheter with a "Statlock" type stabilizer. The catheter exit point must be covered, at a minimum by a sterile occlusive dressing with a transparent semi-permeable membrane, otherwise referred to as a "transparent dressing".
According to available data, tissue puncture results in bleeding at the puncture site in 25% to 40% of procedures. This bleeding necessitates the application of a sterile compress prior to covering with a transparent dressing. The skin puncture site (also known as the catheter exit point) requires the dressing to be repeated on D1 after insertion.
To sum up:
- If there is no bleeding, there is no need to apply a compress, and the dressing can be changed on D8 after application;
- In the presence of bleeding, a compress is applied and dressing change is mandatory on D1 after application.
PICC placement combined with the use of cyanoacrylate glue would reduce the risk of bleeding, and therefore the need to use of a compress, compared with a standard procedure (without the use of glue).
On this basis, the investigators propose to conduct a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in patients with cancer.
- Conditions
- Cancer
- Being tested
- Cyanoacrylate glue application
- Keywords
- Cancer, Peripherally Inserted Central Catheter (PICC), Cyanoacrylate Glue
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate glue applicationProcedure or surgery
The wound must be positioned in a horizontal plane, and the glueapplied uniformly overhanging the wound. Cyanoacrylate glue is contraindicated when adhesion cannot be achieved.
Cyanoacrylate glue should be applied in accordance with the instructions for use.
Wound-closing properties are only fully achieved once the first layer has fully polymerized. This depends on skin type, skin hydration and ambient humidity. If a second layer is applied, the polymerization time is extended accordingly.
| Study group | Role | What they receive |
|---|---|---|
| PICC placement according to standard practice + cyanoacrylate glue | Experimental | PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps).
The catheter will be secured by the Statlock system. Cyanoacrylate glue will be applied on the catheter exit point in accordance with the instructions for use.
A transparent dressing will be applied, with a compress in the event of bleeding. Receives: Procedure: Cyanoacrylate glue application |
| PICC placement according to standard practice | No intervention | PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps). The catheter will be secured by the Statlock system. A transparent dressing will be applied, with a compress in the event of bleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with successful PICC placement
Success is defined by the possibility of using a dressing without compression at application (at hour 0), i.e. without bleeding after the defined compression time.
Measured: Hour 0
Secondary outcomes (5)
Proportion of dressing changes within one hour
Proportion of patients requiring dressing changes at the CLB within one hour of the end of procedure
Measured: Up to hour 1
Proportion of dressing changes before day 8
Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 8)
Measured: Up to day 8
Proportion of dressing changes before day 30
Proportion of patients requiring dressing changes (home nursing/home care/home hospitalization) in the medium term (day 30)
Measured: Up to day 30
Incidence of PICC removal before day 30
Incidence of PICC removal for any reason within 30 days following placement.
Measured: Up to day 30
Incidence of PICC-related complications before day 30
Incidence of PICC-related complications (infection, thrombotic event, obstruction, displacement requiring PICC replacement or not) in the 30 days following placement.
Measured: Up to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start2 Aug 2023
- Primary completion19 Jun 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization (1:1 ratio) will be stratified according to the risk of haemostasis disorders (Presence of at least one risk factor (medication interfering with hemostasis, innate or acquired coagulation disorder, thrombocytopenia) vs. no risk).
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire WALLON, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944900
- Sponsor's protocol ID
- ET23-122
- Acronym
- PICCandGLUE
- Status last verified
- Sep 2024
- First submitted
- 5 Jul 2023
- Last updated
- 27 Sep 2024
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Single-center Trial Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone (Without Glue) in Patients With Cancer.
- ClinicalTrials.gov ID
- NCT05944900
- Acronym / sponsor ID
- PICCandGLUE / ET23-122
- Conditions
- Cancer
- Keywords
- Cancer, Peripherally Inserted Central Catheter (PICC), Cyanoacrylate Glue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 13 Jul 2023 (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 is a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in cancer patients.
Detailed description
Peripherally Inserted Central Catheters (PICCs) are a form of vascular access inserted percutaneously into a vein, usually in the arm, with the distal end at the atrio cava junction (between the superior vena cava and the right atrium). They may be used for a prolonged period or for several days, repeatedly over time (as is the case for certain chemotherapies, parenteral nutrition or long-term intravenous treatments).
Their placement requires aseptic surgical conditions, and a team trained in the procedure, sometimes grouped together in a Vascular Access Unit (UAV).
A PICC is inserted by puncturing the skin and subcutaneous tissues, and securing the catheter with a "Statlock" type stabilizer. The catheter exit point must be covered, at a minimum by a sterile occlusive dressing with a transparent semi-permeable membrane, otherwise referred to as a "transparent dressing".
According to available data, tissue puncture results in bleeding at the puncture site in 25% to 40% of procedures. This bleeding necessitates the application of a sterile compress prior to covering with a transparent dressing. The skin puncture site (also known as the catheter exit point) requires the dressing to be repeated on D1 after insertion.
To sum up:
- If there is no bleeding, there is no need to apply a compress, and the dressing can be changed on D8 after application;
- In the presence of bleeding, a compress is applied and dressing change is mandatory on D1 after application.
PICC placement combined with the use of cyanoacrylate glue would reduce the risk of bleeding, and therefore the need to use of a compress, compared with a standard procedure (without the use of glue).
On this basis, the investigators propose to conduct a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in patients with cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization (1:1 ratio) will be stratified according to the risk of haemostasis disorders (Presence of at least one risk factor (medication interfering with hemostasis, innate or acquired coagulation disorder, thrombocytopenia) vs. no risk).
| Arm | Type | Receives |
|---|---|---|
| PICC placement according to standard practice + cyanoacrylate glue | Experimental | Procedure: Cyanoacrylate glue applicationPICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps). The catheter will be secured by the Statlock system. Cyanoacrylate glue will be applied on the catheter exit point in accordance with the instructions for use. A transparent dressing will be applied, with a compress in the event of bleeding. |
| PICC placement according to standard practice | No intervention | –PICC placement will be performed according to standard practice (Safe Insertion of PICC protocol (SIP2) steps). The catheter will be secured by the Statlock system. A transparent dressing will be applied, with a compress in the event of bleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18 years of age or older on the date of signature the informed consent form
- Patient with a histological diagnosis of cancer
- Indication for central line chemotherapy or immunotherapy
- Placement of a single-lumen PICC in the non-tunneled upper limb planned on an ambulatory basis at the Centre
- Planned duration of PICC use > 30 days
Key exclusion criteria (5 listed)
- Patient already included in the study ;
- Patient with known allergy to cyanoacrylates, Violet D\&C or formaldehyde;
- Patient not reachable by telephone ;
- Patient under guardianship;
- Patient does not speak French.
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 |
|---|---|---|
| Cyanoacrylate glue applicationThe wound must be positioned in a horizontal plane, and the glueapplied uniformly overhanging the wound. Cyanoacrylate glue is contraindicated when adhesion cannot be achieved. Cyanoacrylate glue should be applied in accordance with the instructions for use. Wound-closing properties are only fully achieved once the first layer has fully polymerized. This depends on skin type, skin hydration and ambient humidity. If a second layer is applied, the polymerization time is extended accordingly. | Procedure or surgery | PICC placement according to standard practice + cyanoacrylate glue |
Primary outcome
Rate of patients with successful PICC placement
Time frame: Hour 0
Success is defined by the possibility of using a dressing without compression at application (at hour 0), i.e. without bleeding after the defined compression time.
5 secondary outcomes
Proportion of dressing changes within one hour
Time frame: Up to hour 1
Proportion of dressing changes before day 8
Time frame: Up to day 8
Proportion of dressing changes before day 30
Time frame: Up to day 30
Incidence of PICC removal before day 30
Time frame: Up to day 30
Incidence of PICC-related complications before day 30
Time frame: Up to day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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.
Grégoire WALLON, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyanoacrylate glue application in people with Cancer, run by Centre Leon Berard at 1 site in France.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 27 Sep 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with successful PICC placement (time frame: Hour 0). 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 27 Sep 2024.